<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04409002</url>
  </required_header>
  <id_info>
    <org_study_id>19-538</org_study_id>
    <nct_id>NCT04409002</nct_id>
  </id_info>
  <brief_title>Niraparib + Dostarlimab + RT in Pancreatic Cancer</brief_title>
  <official_title>A Phase II Study of Niraparib and Dostarlimab With Radiation in Patients With Metastatic Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tesaro, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is being done to see how the combination of dostarlimab, niraparib, and&#xD;
      radiation therapy works in controlling metastatic pancreatic cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This two-stage single arm phase II trial will evaluate the efficacy of niraparib with&#xD;
      dostarlimab and radiation therapy in patients with metastatic pancreatic cancer&#xD;
&#xD;
      The research study procedures include screening for eligibility and study treatment including&#xD;
      evaluations and follow up visits.&#xD;
&#xD;
      The names of the experimental interventions involved in this study are:&#xD;
&#xD;
        -  Dostarlimab&#xD;
&#xD;
        -  Niraparib&#xD;
&#xD;
        -  Radiation Therapy&#xD;
&#xD;
      It is expected that about 25 people will take part in this research study. An initial 15&#xD;
      participants will be enrolled during the first stage and evaluated for treatment disease&#xD;
      control, if none of the initial 15 participants achieve disease control the study will be&#xD;
      terminated.&#xD;
&#xD;
      It is expected participants will be on the research study for as long as the experimental&#xD;
      interventions are safe, and their metastatic pancreatic cancer does not progress with up to 5&#xD;
      years of follow up after participants stop taking the experimental interventions.&#xD;
&#xD;
      This research study is a Phase II clinical trial. Phase II clinical trials test the safety&#xD;
      and effectiveness of an investigational intervention to learn whether the intervention works&#xD;
      in treating a specific disease. &quot;Investigational&quot; means that the intervention is being&#xD;
      studied.&#xD;
&#xD;
      The U.S. Food and Drug Administration (FDA) has not approved dostarlimab as a treatment for&#xD;
      any disease. Dostarlimab is a type of antibody (a protein that attaches to other cells to&#xD;
      fight off infection) that is believed to work by attaching to a protein called PD-1 on&#xD;
      Tcells.&#xD;
&#xD;
      This PD-1 protein controls parts of the immune system (the system in the body that fights off&#xD;
      infections and diseases) by shutting down certain immune responses responsible for&#xD;
      recognizing and destroying cancer cells. The investigators believe that dostarlimab will&#xD;
      inhibit the PD-1 protein, thus allowing the immune cells to recognize and destroy cancer&#xD;
      cells. The FDA has not approved niraparib for metastatic pancreatic cancer, but it has been&#xD;
      approved for other uses. Niraparib is a type of drug called a &quot;PARP inhibitor&quot;, which blocks&#xD;
      DNA (the genetic material of cells) damage from being repaired or may prevent damage from&#xD;
      occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells&#xD;
      by not allowing the cancer cells to repair its DNA damage or prevent DNA damage from&#xD;
      occurring. It is believed that the combination of dostarlimab, niraparib, and radiation&#xD;
      therapy may have a greater effect on metastatic pancreatic cancer cells than when these&#xD;
      interventions are used alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Actual">February 25, 2022</completion_date>
  <primary_completion_date type="Actual">January 19, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease Control Rate With RECIST 1.1 Criteria</measure>
    <time_frame>up to 17 months</time_frame>
    <description>Disease control rate (DCR) is the percentage of participants who experienced a complete response (CR), partial response (PR), or stable disease (SD) assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria below.&#xD;
CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
PR = At least 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters.&#xD;
SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the baseline sum diameters while on study.&#xD;
Progressive Disease (PD) = At least 20% increase in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters while on study. Appearance of one or more new lesions is also considered progression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate With irRECIST Criteria</measure>
    <time_frame>up to 17 months</time_frame>
    <description>Disease control rate (DCR) is the percentage of participants who experienced a immune-related complete response (irCR), partial response (irPR), or stable disease (irSD) assessed by the Immune-Related Response Evaluation Criteria In Solid Tumors (irRECIST) criteria below.&#xD;
irCR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
irPR = At least 30% decrease in the sum of longest diameters of target lesions, compared to baseline.&#xD;
irSD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, compared to baseline.&#xD;
Immune-related Progressive Disease (irPD) = At least 20% increase in the sum of longest diameters of target lesions AND at least 5mm absolute increase, compared to baseline. Appearance of one or more new lesions is also considered progression. Confirmation scan required at least 4 weeks later.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival</measure>
    <time_frame>up to 17 months</time_frame>
    <description>Progression-free survival (PFS) is defined as the time duration from the first day of protocol treatment to the earlier date of disease progression or death due to any cause. PFS time will be censored at the date of last follow-up for surviving patients with disease control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>up to 17 months</time_frame>
    <description>Overall survival (OS) is defined as the time duration from the first day of protocol treatment to the date of death due to any cause, and will be censored at the date of last follow-up for patients still alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment-Related Adverse Events Per CTCAE v5.0</measure>
    <time_frame>up to 19 weeks</time_frame>
    <description>Treatment-related adverse events (TRAEs) are evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, as grades 3-5 and at least possibly attributed to study treatment. TRAEs are evaluated from the start of study treatment through 30-days after the last treatment dose.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Pancreatic Cancer</condition>
  <condition>Metastatic Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Niraparib+Dostarlimab + Radiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each study treatment cycle lasts 21 days&#xD;
Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment&#xD;
Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study&#xD;
Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Niraparib</intervention_name>
    <description>Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment</description>
    <arm_group_label>Niraparib+Dostarlimab + Radiation</arm_group_label>
    <other_name>Zejula</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dostarlimab</intervention_name>
    <description>Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study</description>
    <arm_group_label>Niraparib+Dostarlimab + Radiation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation</intervention_name>
    <description>Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1</description>
    <arm_group_label>Niraparib+Dostarlimab + Radiation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed metastatic adenocarcinoma of pancreatic&#xD;
             origin.&#xD;
&#xD;
          -  Age &gt; 18 years.&#xD;
&#xD;
          -  ECOG performance status ≤ 1.&#xD;
&#xD;
          -  Life expectancy of greater than 3 months.&#xD;
&#xD;
          -  Participants must have normal organ and marrow function as defined below:&#xD;
&#xD;
               -  leukocytes ≥ 2,000/mcL&#xD;
&#xD;
               -  absolute neutrophil count ≥ 1,500/mcL&#xD;
&#xD;
               -  platelets ≥ 100,000/mcL&#xD;
&#xD;
               -  hemoglobin ≥ 9 g/dL&#xD;
&#xD;
               -  AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal(subjects with&#xD;
                  liver metastases can have an AST (SGOT) ≤ 5 x ULN&#xD;
&#xD;
               -  creatinine ≤ 1.5 x ULN OR&#xD;
&#xD;
               -  creatinine clearance* ≥ 60 mL/min (if using the Cockcroft-Gault formula)&#xD;
&#xD;
               -  total bilirubin ≤ 1.5 x ULN (subjects with Gilbert Syndrome can have a total&#xD;
                  bilirubin &lt; 3 x ULN)&#xD;
&#xD;
               -  INR, PT, aPTT ≤ 1.5 x ULN (subjects receiving anticoagulant therapy must have PT&#xD;
                  or PTT within therapeutic range) *Creatinine clearance should be calculated per&#xD;
                  the following: CrCl (mL/min) = (140 - age [years]) x weight [kg] x 1.23 (x 0.85&#xD;
                  if female)/ Serum creatinine (micromol/L)&#xD;
&#xD;
          -  Women of childbearing potential (WoCBP) must have a negative serum or urine pregnancy&#xD;
             test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to&#xD;
             initiating protocol therapy.&#xD;
&#xD;
        Non childbearing potential is defined as follows (by other than medical reasons):&#xD;
&#xD;
          -  ≥45 years of age and has not had menses for &gt;1 year&#xD;
&#xD;
          -  Patients who have been amenorrhoeic for &lt;2 years without history of a hysterectomy and&#xD;
             oophorectomy must have a follicle stimulating hormone value in the postmenopausal&#xD;
             range upon screening evaluation&#xD;
&#xD;
          -  Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented&#xD;
             hysterectomy or oophorectomy must be confirmed with medical records of the actual&#xD;
             procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical&#xD;
             records of the actual procedure, otherwise the patient must be willing to use 2&#xD;
             adequate barrier methods throughout the study, starting with the screening visit&#xD;
             through 150 days after the last dose of study treatment. See Section 4.4 for a list of&#xD;
             acceptable birth control methods. Information must be captured appropriately within&#xD;
             the site's source documents. Note: Abstinence is acceptable if this is the established&#xD;
             and preferred contraception for the patient.&#xD;
&#xD;
               -  Women of childbearing potential must agree to use appropriate method(s) of&#xD;
                  contraception. WOCBP should use an adequate method to avoid pregnancy for 6&#xD;
                  months (30 days plus the time required for niraparib to undergo five&#xD;
                  half-lives/150 days) after the last dose of investigational drug.&#xD;
&#xD;
               -  Women must not be breastfeeding during the study or for 150 days after the last&#xD;
                  dose of investigational drug.&#xD;
&#xD;
               -  Men who are sexually active with WoCBP must use any contraceptive method with a&#xD;
                  failure rate of less than 1% per year. Men receiving protocol therapy and who are&#xD;
                  sexually active with WoCBP will be instructed to adhere to contraception for a&#xD;
                  period of 6 months (150 days) after the last dose of investigational product.&#xD;
                  (Women who are not of childbearing potential, i.e. are postmenopausal as defined&#xD;
                  in the eligibility criteria or surgically sterile, as well as azoospermic men do&#xD;
                  not require contraception.) Ability to understand and the willingness to sign a&#xD;
                  written informed consent document&#xD;
&#xD;
               -  If applicable, stable dose of dexamethasone of 10mg or less for 4 weeks prior to&#xD;
                  initiation of investigational protocol therapy. Regimen must be completed &gt;14&#xD;
                  days prior to treatment start.&#xD;
&#xD;
               -  One previously unirradiated lesion amenable to radiotherapy at a dose of 8 Gy x 3&#xD;
                  and can meet dose constraints, and another unirradiated measurable lesion &gt; 1 cm&#xD;
                  in size outside the radiation field that can be used as measurable disease.&#xD;
&#xD;
               -  Patients must have had at least one line of prior treatment. Any prior line of&#xD;
                  treatment is permitted, including adjuvant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants who meet any of the following criteria will be excluded:&#xD;
&#xD;
          -  Systemic anticancer or biological therapy including prior chemotherapy, immunotherapy,&#xD;
             targeted small molecule therapy within 14 days prior to investigational agent, or&#xD;
             those who have not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due&#xD;
             to agents administered more than 2 weeks earlier. Participants with ≤ grade 2&#xD;
             neuropathy are an exception to these criteria and may qualify for the study. If the&#xD;
             participant received major surgery, then they must have recovered adequately from the&#xD;
             toxicity and/or complications from the intervention prior to starting therapy.&#xD;
&#xD;
          -  Received investigational therapy ≥ 4 weeks, or within a time interval less than at&#xD;
             least 5 half-lives of the investigational agent, whichever is shorter, prior&#xD;
             initiating protocol therapy.&#xD;
&#xD;
          -  Major surgery ≤ 3 weeks prior to initiating protocol therapy and/or not recovered from&#xD;
             any surgical effects.&#xD;
&#xD;
          -  Received radiation therapy encompassing &gt;20% of the bone marrow within 2 weeks; or any&#xD;
             radiation therapy within 1 week prior to day 1 of protocol therapy.&#xD;
&#xD;
          -  Received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating&#xD;
             protocol therapy&#xD;
&#xD;
          -  Received colony-stimulating factors (e.g., granulocyte colony-stimulating factor,&#xD;
             granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin)&#xD;
             within 4 weeks prior to initiating protocol therapy. Known history of Grade 3 or 4&#xD;
             anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted &gt; 4&#xD;
             weeks and was related to the most recent treatment.&#xD;
&#xD;
          -  Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).&#xD;
&#xD;
          -  Active, known or suspected autoimmune disease that has required systemic treatment&#xD;
             within the past 2 years other than vitiligo, type I diabetes mellitus, residual&#xD;
             hypothyroidism due to autoimmune condition only requiring hormone replacement,&#xD;
             psoriasis not requiring systemic treatment, or conditions not expected to recur in the&#xD;
             absence of an external trigger.&#xD;
&#xD;
          -  Any condition requiring systemic treatment with either corticosteroids (&gt; 10 mg daily&#xD;
             prednisone equivalents) or other immunosuppressive medications within 14 days of study&#xD;
             drug administration. Inhaled or topical steroids and adrenal replacement doses &gt; 10 mg&#xD;
             daily prednisone equivalents are permitted in the absence of active autoimmune&#xD;
             disease. Participants are permitted to use topical, ocular, intraarticular,&#xD;
             intranasal, and inhalational corticosteroids (with minimal systemic absorption).&#xD;
             Physiologic replacement doses of systemic corticosteroids are permitted, even if &gt; 10&#xD;
             mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis&#xD;
             (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g.,&#xD;
             delayed-type hypersensitivity reaction caused by contact allergen) is permitted.&#xD;
&#xD;
          -  Known history of active TB (Bacillus Tuberculosis). Testing is not required for&#xD;
             eligibility purposes.&#xD;
&#xD;
          -  Known hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic&#xD;
             acid (HCV antibody) indicating acute or chronic infection. Testing is not required for&#xD;
             eligibility purposes.&#xD;
&#xD;
          -  Known history of testing positive for human immunodeficiency virus (HIV) or known&#xD;
             acquired immunodeficiency syndrome (AIDS). These participants are at increased risk of&#xD;
             lethal infections when treated with marrow suppressive therapy. Testing is not&#xD;
             required for eligibility purposes.&#xD;
&#xD;
          -  Known ≥ Grade 3 immune-related AE with prior immunotherapy, with the exception of&#xD;
             non-clinically significant lab abnormalities.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, recent (within 90 days) myocardial infarction or psychiatric&#xD;
             illness/social situations that would limit compliance with study requirements.&#xD;
&#xD;
          -  Known psychiatric or substance abuse disorders that would interfere with cooperation&#xD;
             with the requirements of the trial.&#xD;
&#xD;
          -  Known additional malignancy diagnosed, detected or treated ≤ 2 years prior to&#xD;
             initiation of protocol therapy . Exceptions include basal cell carcinoma of the skin&#xD;
             and squamous cell carcinoma of the skin that has undergone potentially curative&#xD;
             therapy or in situ cervical cancer.&#xD;
&#xD;
          -  Known history of, or any evidence of active, non-infectious pneumonitis or&#xD;
             interstitial lung disease.&#xD;
&#xD;
          -  Active infection requiring systemic therapy&#xD;
&#xD;
          -  Has received a live vaccine within 30 days of planned start of study therapy. Note:&#xD;
&#xD;
        Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are&#xD;
        allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated&#xD;
        vaccines, and are not allowed.&#xD;
&#xD;
          -  Known hypersensitivity to niraparib and dostarlimab components or excipients.&#xD;
&#xD;
          -  History of severe hypersensitivity reaction to any monoclonal antibody&#xD;
&#xD;
          -  Participants with known brain metastases should be excluded from this clinical trial&#xD;
             because of their poor prognosis and because they often develop progressive neurologic&#xD;
             dysfunction that would confound the evaluation of neurologic and other adverse events.&#xD;
&#xD;
        Further imaging is not required for eligibility purposes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theodore S Hong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital Cancer Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <results_first_submitted>June 14, 2023</results_first_submitted>
  <results_first_submitted_qc>June 14, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 3, 2023</results_first_posted>
  <last_update_submitted>June 30, 2023</last_update_submitted>
  <last_update_submitted_qc>June 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Theodore Sunki Hong</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Pancreatic Cancer</keyword>
  <keyword>Metastatic Pancreatic Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Niraparib</mesh_term>
    <mesh_term>Dostarlimab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication</ipd_time_frame>
    <ipd_access_criteria>Contact the Partners Innovations team at http://www.partners.org/innovation</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 21, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT04409002/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Niraparib+Dostarlimab + Radiation</title>
          <description>Each study treatment cycle lasts 21 days&#xD;
Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment&#xD;
Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study&#xD;
Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1&#xD;
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment&#xD;
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study&#xD;
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease progression prior to starting study treatment</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Niraparib+Dostarlimab + Radiation</title>
          <description>Each study treatment cycle lasts 21 days&#xD;
Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment&#xD;
Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study&#xD;
Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1&#xD;
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment&#xD;
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study&#xD;
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age 30-39 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 40-49 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 50-59 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 60-69 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 70-79 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Disease Control Rate With RECIST 1.1 Criteria</title>
        <description>Disease control rate (DCR) is the percentage of participants who experienced a complete response (CR), partial response (PR), or stable disease (SD) assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria below.&#xD;
CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
PR = At least 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters.&#xD;
SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the baseline sum diameters while on study.&#xD;
Progressive Disease (PD) = At least 20% increase in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters while on study. Appearance of one or more new lesions is also considered progression.</description>
        <time_frame>up to 17 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Niraparib+Dostarlimab + Radiation</title>
            <description>Each study treatment cycle lasts 21 days&#xD;
Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment&#xD;
Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study&#xD;
Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1&#xD;
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment&#xD;
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study&#xD;
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate With RECIST 1.1 Criteria</title>
          <description>Disease control rate (DCR) is the percentage of participants who experienced a complete response (CR), partial response (PR), or stable disease (SD) assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria below.&#xD;
CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
PR = At least 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters.&#xD;
SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the baseline sum diameters while on study.&#xD;
Progressive Disease (PD) = At least 20% increase in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters while on study. Appearance of one or more new lesions is also considered progression.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate With irRECIST Criteria</title>
        <description>Disease control rate (DCR) is the percentage of participants who experienced a immune-related complete response (irCR), partial response (irPR), or stable disease (irSD) assessed by the Immune-Related Response Evaluation Criteria In Solid Tumors (irRECIST) criteria below.&#xD;
irCR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
irPR = At least 30% decrease in the sum of longest diameters of target lesions, compared to baseline.&#xD;
irSD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, compared to baseline.&#xD;
Immune-related Progressive Disease (irPD) = At least 20% increase in the sum of longest diameters of target lesions AND at least 5mm absolute increase, compared to baseline. Appearance of one or more new lesions is also considered progression. Confirmation scan required at least 4 weeks later.</description>
        <time_frame>up to 17 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Niraparib+Dostarlimab + Radiation</title>
            <description>Each study treatment cycle lasts 21 days&#xD;
Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment&#xD;
Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study&#xD;
Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1&#xD;
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment&#xD;
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study&#xD;
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate With irRECIST Criteria</title>
          <description>Disease control rate (DCR) is the percentage of participants who experienced a immune-related complete response (irCR), partial response (irPR), or stable disease (irSD) assessed by the Immune-Related Response Evaluation Criteria In Solid Tumors (irRECIST) criteria below.&#xD;
irCR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
irPR = At least 30% decrease in the sum of longest diameters of target lesions, compared to baseline.&#xD;
irSD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, compared to baseline.&#xD;
Immune-related Progressive Disease (irPD) = At least 20% increase in the sum of longest diameters of target lesions AND at least 5mm absolute increase, compared to baseline. Appearance of one or more new lesions is also considered progression. Confirmation scan required at least 4 weeks later.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival</title>
        <description>Progression-free survival (PFS) is defined as the time duration from the first day of protocol treatment to the earlier date of disease progression or death due to any cause. PFS time will be censored at the date of last follow-up for surviving patients with disease control.</description>
        <time_frame>up to 17 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Niraparib+Dostarlimab + Radiation</title>
            <description>Each study treatment cycle lasts 21 days&#xD;
Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment&#xD;
Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study&#xD;
Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1&#xD;
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment&#xD;
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study&#xD;
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival</title>
          <description>Progression-free survival (PFS) is defined as the time duration from the first day of protocol treatment to the earlier date of disease progression or death due to any cause. PFS time will be censored at the date of last follow-up for surviving patients with disease control.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="1.1" upper_limit="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>Overall survival (OS) is defined as the time duration from the first day of protocol treatment to the date of death due to any cause, and will be censored at the date of last follow-up for patients still alive.</description>
        <time_frame>up to 17 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Niraparib+Dostarlimab + Radiation</title>
            <description>Each study treatment cycle lasts 21 days&#xD;
Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment&#xD;
Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study&#xD;
Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1&#xD;
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment&#xD;
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study&#xD;
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Overall survival (OS) is defined as the time duration from the first day of protocol treatment to the date of death due to any cause, and will be censored at the date of last follow-up for patients still alive.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="1.5" upper_limit="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment-Related Adverse Events Per CTCAE v5.0</title>
        <description>Treatment-related adverse events (TRAEs) are evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, as grades 3-5 and at least possibly attributed to study treatment. TRAEs are evaluated from the start of study treatment through 30-days after the last treatment dose.</description>
        <time_frame>up to 19 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Niraparib+Dostarlimab + Radiation</title>
            <description>Each study treatment cycle lasts 21 days&#xD;
Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment&#xD;
Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study&#xD;
Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1&#xD;
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment&#xD;
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study&#xD;
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment-Related Adverse Events Per CTCAE v5.0</title>
          <description>Treatment-related adverse events (TRAEs) are evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, as grades 3-5 and at least possibly attributed to study treatment. TRAEs are evaluated from the start of study treatment through 30-days after the last treatment dose.</description>
          <units>treatment-related adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 3 TRAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 TRAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5 TRAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 17 months</time_frame>
      <desc>Adverse event evaluations per CTCAE v5.0</desc>
      <group_list>
        <group group_id="E1">
          <title>Niraparib+Dostarlimab + Radiation</title>
          <description>Each study treatment cycle lasts 21 days&#xD;
Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment&#xD;
Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study&#xD;
Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1&#xD;
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment&#xD;
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study&#xD;
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (Unspecified)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (Unspecified)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic valve disease</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye disorders - Other, specify</sub_title>
                <description>blood in the corner of right eye. no pain. no change in vision</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Scleral disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, specify</sub_title>
                <description>radiation induced proctitis</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Gastrointestinal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hemorrhoidal hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Oral hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Rectal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Localized edema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Portal vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteremia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Biliary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Endocarditis infective</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Thrush</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Gastric anastomotic leak</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Cardiac troponin T increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>CD4 lymphocytes decreased</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Thyroid stimulating hormone increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hypercalcemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hyperlipidemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Buttock pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Generalized muscle weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Muscle cramp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Muscle weakness lower limb</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify</sub_title>
                <description>Primary malignant neoplasm of endometrium</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Glucosuria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Renal calculi</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Urinary frequency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Urine discoloration</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Prostatic obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Reproductive system and breast disorders - Other, specify</sub_title>
                <description>Breast Cancer</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Vaginal dryness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Papulopustular rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Rash acneiform</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Skin ulceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Superficial thrombophlebitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>A two-stage design was used, requiring disease control in at least one of the first 15 patients before proceeding to the full accrual of 25 patients.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Theodore Hong, MD</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-726-6050</phone>
      <email>TSHONG1@mgh.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04409002
org study id: 19-538
nct id: NCT04409002
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This research is being done to see how the combination of dostarlimab, niraparib, and
      radiation therapy works in controlling metastatic pancreatic cancer.
This two-stage single arm phase II trial will evaluate the efficacy of niraparib with
      dostarlimab and radiation therapy in patients with metastatic pancreatic cancer

      The research study procedures include screening for eligibility and study treatment including
      evaluations and follow up visits.

      The names of the experimental interventions involved in this study are:

        -  Dostarlimab

        -  Niraparib

        -  Radiation Therapy

      It is expected that about 25 people will take part in this research study. An initial 15
      participants will be enrolled during the first stage and evaluated for treatment disease
      control, if none of the initial 15 participants achieve disease control the study will be
      terminated.

      It is expected participants will be on the research study for as long as the experimental
      interventions are safe, and their metastatic pancreatic cancer does not progress with up to 5
      years of follow up after participants stop taking the experimental interventions.

      This research study is a Phase II clinical trial. Phase II clinical trials test the safety
      and effectiveness of an investigational intervention to learn whether the intervention works
      in treating a specific disease. "Investigational" means that the intervention is being
      studied.

      The U.S. Food and Drug Administration (FDA) has not approved dostarlimab as a treatment for
      any disease. Dostarlimab is a type of antibody (a protein that attaches to other cells to
      fight off infection) that is believed to work by attaching to a protein called PD-1 on
      Tcells.

      This PD-1 protein controls parts of the immune system (the system in the body that fights off
      infections and diseases) by shutting down certain immune responses responsible for
      recognizing and destroying cancer cells. The investigators believe that dostarlimab will
      inhibit the PD-1 protein, thus allowing the immune cells to recognize and destroy cancer
      cells. The FDA has not approved niraparib for metastatic pancreatic cancer, but it has been
      approved for other uses. Niraparib is a type of drug called a "PARP inhibitor", which blocks
      DNA (the genetic material of cells) damage from being repaired or may prevent damage from
      occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells
      by not allowing the cancer cells to repair its DNA damage or prevent DNA damage from
      occurring. It is believed that the combination of dostarlimab, niraparib, and radiation
      therapy may have a greater effect on metastatic pancreatic cancer cells than when these
      interventions are used alone.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease Control Rate With RECIST 1.1 Criteria
time frame: up to 17 months
description: Disease control rate (DCR) is the percentage of participants who experienced a complete response (CR), partial response (PR), or stable disease (SD) assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria below.
CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
PR = At least 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters.
SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the baseline sum diameters while on study.
Progressive Disease (PD) = At least 20% increase in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters while on study. Appearance of one or more new lesions is also considered progression.
measure: Disease Control Rate With irRECIST Criteria
time frame: up to 17 months
description: Disease control rate (DCR) is the percentage of participants who experienced a immune-related complete response (irCR), partial response (irPR), or stable disease (irSD) assessed by the Immune-Related Response Evaluation Criteria In Solid Tumors (irRECIST) criteria below.
irCR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
irPR = At least 30% decrease in the sum of longest diameters of target lesions, compared to baseline.
irSD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, compared to baseline.
Immune-related Progressive Disease (irPD) = At least 20% increase in the sum of longest diameters of target lesions AND at least 5mm absolute increase, compared to baseline. Appearance of one or more new lesions is also considered progression. Confirmation scan required at least 4 weeks later.
measure: Progression-free Survival
time frame: up to 17 months
description: Progression-free survival (PFS) is defined as the time duration from the first day of protocol treatment to the earlier date of disease progression or death due to any cause. PFS time will be censored at the date of last follow-up for surviving patients with disease control.
measure: Overall Survival
time frame: up to 17 months
description: Overall survival (OS) is defined as the time duration from the first day of protocol treatment to the date of death due to any cause, and will be censored at the date of last follow-up for patients still alive.
measure: Number of Treatment-Related Adverse Events Per CTCAE v5.0
time frame: up to 19 weeks
description: Treatment-related adverse events (TRAEs) are evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, as grades 3-5 and at least possibly attributed to study treatment. TRAEs are evaluated from the start of study treatment through 30-days after the last treatment dose.
arm group label: Niraparib+Dostarlimab + Radiation
arm group type: Experimental
description: Each study treatment cycle lasts 21 days
Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
intervention type: Drug
intervention name: Niraparib
description: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
arm group label: Niraparib+Dostarlimab + Radiation
other name: Zejula
intervention type: Drug
intervention name: Dostarlimab
description: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
arm group label: Niraparib+Dostarlimab + Radiation
intervention type: Radiation
intervention name: Radiation
description: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
arm group label: Niraparib+Dostarlimab + Radiation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Theodore S Hong, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Theodore Sunki Hong
investigator title: Principal Investigator
mesh term: Pancreatic Neoplasms
mesh term: Niraparib
mesh term: Dostarlimab
sharing ipd: Yes
ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data can be shared no earlier than 1 year following the date of publication
ipd access criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: A two-stage design was used, requiring disease control in at least one of the first 15 patients before proceeding to the full accrual of 25 patients.
point of contact: 