<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/NCT03833479</url>
  </required_header>
  <id_info>
    <org_study_id>GEICO 78-C (ATOMICC)</org_study_id>
    <secondary_id>2018-002155-15</secondary_id>
    <nct_id>NCT03833479</nct_id>
  </id_info>
  <brief_title>TSR-042 as Maintenance Therapy for Patients With High-risk Locally Advanced Cervical Cancer After Chemo-radiation (ATOMICC)</brief_title>
  <acronym>ATOMICC</acronym>
  <official_title>A Randomized, Open Label, Phase II Trial of Anti-PD1, TSR-042, as Maintenance Therapy for Patients With High-risk Locally Advanced Cervical Cancer After Chemo-radiation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo Español de Investigación en Cáncer de Ovario</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>TESARO/GSK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Apices Soluciones S.L.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Grupo Español de Investigación en Cáncer de Ovario</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with locally advanced cervical cancer (LACC) despite definitive chemo-radiotherapy,&#xD;
      has a poor progression-free survival (PFS) and overall survival (OS). The hypothesis is that&#xD;
      the use of TSR-042, checkpoint inhibitor, as consolidation therapy following concurrent&#xD;
      chemo-radiation would increase PFS in these patients. The incorporation of immunotherapy&#xD;
      after chemo-radiation is one the best scenarios for this approach, since takes advantages of&#xD;
      &quot;the ideal microenvironment&quot; created after radiation. In a similar rationale, the phase 3&#xD;
      study that compared the anti-programmed death ligand 1 antibody durvalumab as consolidation&#xD;
      therapy with placebo in patients with stage III NSCLC who did not have disease progression&#xD;
      after two or more cycles of platinum-based chemoradiotherapy, showed that progression-free&#xD;
      survival was significantly longer with durvalumab than with placebo in all sub-groups&#xD;
      regardless of response obtained to chemotherapy, namely patients with stable disease (SD)&#xD;
      gained the same benefit that patients with partial response (PR). Due to the aforementioned&#xD;
      biology of cervical cancer, the proven activity of anti programmed cell death protein 1&#xD;
      (Anti-PD1) agents in metastatic and/or recurrent cervical cancer and the poor PFS and OS in&#xD;
      patients with LACC despite definitive chemo-radiotherapy, we consider to analyze the Anti-PD1&#xD;
      agent, TSR-042 as maintenance therapy after concurrent chemo-radiation (CCRT)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 28, 2019</start_date>
  <completion_date type="Anticipated">October 2025</completion_date>
  <primary_completion_date type="Anticipated">October 2025</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>30 months</time_frame>
    <description>Time from the date of randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first based on investigator assessment using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency and severity of adverse events (AEs)</measure>
    <time_frame>30 months</time_frame>
    <description>Incidence, nature and severity of adverse events (AEs) assessed by CTCAE version 4.03</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>30 months</time_frame>
    <description>Time from the date of randomization to the date of death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcomes (PROs) of health-related quality of life (HRQOL)</measure>
    <time_frame>30 months</time_frame>
    <description>Mean changes from baseline score assessed by the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcomes (PROs) of health-related quality of life (HRQOL)</measure>
    <time_frame>30 months</time_frame>
    <description>Mean changes from baseline score assessed by EQ -5D-5L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcomes (PROs) of fatigue</measure>
    <time_frame>30 months</time_frame>
    <description>Mean changes from baseline score assessed by the PROMIS-Cancer-Fatigue Short Form 4a.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcomes (PROs) of pain</measure>
    <time_frame>30 months</time_frame>
    <description>Mean changes from baseline score assessed by a single item of the Brief Pain Inventory (BPI).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">132</enrollment>
  <condition>Cervical Cancer</condition>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>No further treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>No further treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TSR-042</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TSR-042 treatment administered using a 30 -minute IV infusion (with a -5 minute and +15 minute window permitted).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Further Treatment</intervention_name>
    <description>No further treatment</description>
    <arm_group_label>No further treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TSR-042</intervention_name>
    <description>Fixed 500 mg TSR-042 dose Q3W for the first 4 doses followed by a fixed 1000 mg TSR-042 dose Q6W for up to 24 months</description>
    <arm_group_label>TSR-042</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent before any study-specific procedure&#xD;
&#xD;
          2. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status&#xD;
             of ≤ 1&#xD;
&#xD;
          3. Participant must be a female ≥ 18 years of age&#xD;
&#xD;
          4. Life expectancy ≥3 months&#xD;
&#xD;
          5. Participant must have biopsy-confirmed squamous cell carcinoma, adenocarcinoma, or&#xD;
             adenosquamous carcinoma of the cervix.&#xD;
&#xD;
          6. Patients must have archival tumor tissue available that is formalin-fixed and paraffin&#xD;
             embedded.&#xD;
&#xD;
          7. At diagnosis:&#xD;
&#xD;
               -  Federation of Gynecologists and Obstetricians (FIGO) stages IB2, IIA2, IIB with&#xD;
                  pelvic lymph node involvement: Biopsy-proven pelvic node involvement, 2 or more&#xD;
                  positive nodes by magnetic resonance imaging (MRI) or computed tomography (CT)&#xD;
                  (≥1.5 cm shortest dimension), 2 or more positive nodes by Positron Emission&#xD;
                  Tomography (PET) (with standardized uptake values (SUV) ≥2.5)&#xD;
&#xD;
               -  FIGO stages IIIA, IIIB, IVA&#xD;
&#xD;
               -  Any FIGO stage with para-aortic lymph node involvement: Biopsy-proven para-aortic&#xD;
                  node involvement, 1 or more positive nodes by MRI or CT (≥1.5 cm shortest&#xD;
                  dimension), 1 or more positive pelvic nodes by PET (with SUV ≥ 2.5)&#xD;
&#xD;
          8. Subjects must have received combination chemotherapy and radiotherapy (CCRT) with&#xD;
             curative intent. Patients must have received at least 4 doses of weekly cisplatin.&#xD;
&#xD;
          9. Patients must have completed definitive treatment, namely chemo-radiation, up to 12&#xD;
             weeks prior to sign the Informed Consent form.&#xD;
&#xD;
         10. Toxicities resulting from chemo-radiation must resolve to ≤ Grade 1 prior to&#xD;
             randomization.&#xD;
&#xD;
         11. Participant must have adequate organ function, defined as follows:&#xD;
&#xD;
               -  Absolute neutrophil count ≥ 1,500/µL&#xD;
&#xD;
               -  Platelets ≥ 100,000/µL&#xD;
&#xD;
               -  Hemoglobin ≥ 9 g/dL&#xD;
&#xD;
               -  Serum creatinine ≤ 1.5× upper limit of normal (ULN) or calculated creatinine&#xD;
                  clearance ≥ 50 mL/min using Cockcroft-Gault equation for patients with creatinine&#xD;
                  levels &gt; 1.5× institutional ULN&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5× ULN OR direct bilirubin ≤ 1× ULN&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN&#xD;
                  unless liver metastases are present, in which case they must be ≤ 5× ULN&#xD;
&#xD;
               -  International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN unless&#xD;
                  patient is receiving anticoagulant therapy as long as PT or partial&#xD;
                  thromboplastin (PTT) is within therapeutic range of intended use of&#xD;
                  anticoagulants. Activated partial thromboplastin time (aPTT) ≤1.5× ULN unless&#xD;
                  patient is receiving anticoagulant therapy as long as PT or PTT is within&#xD;
                  therapeutic range of intended use of anticoagulants&#xD;
&#xD;
         12. Participant must agree to not donate blood during the study or for 90 days after the&#xD;
             last dose of study treatment.&#xD;
&#xD;
         13. Negative Test Results for Hepatitis&#xD;
&#xD;
         14. Female participant has a negative serum pregnancy test within 72 hours prior to taking&#xD;
             study treatment if of childbearing potential and agrees to abstain from activities&#xD;
             that could result in pregnancy from screening through 150 days after the last dose of&#xD;
             study treatment, or is of nonchildbearing potential.&#xD;
&#xD;
         15. Participant must agree to not breastfeed during the study or for 150 days after the&#xD;
             last dose of study treatment.&#xD;
&#xD;
         16. Male partners must agree to use an adequate method of contraception starting with the&#xD;
             first dose of study treatment through 150 days after the last dose of study treatment.&#xD;
&#xD;
         17. Participant must be able to understand the study procedures and agree to participate&#xD;
             in the study by providing written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Histological types other than in inclusion criteria, like sarcomas, small cell&#xD;
             carcinoma with neuroendocrine differentiation, non-epithelial cancers.&#xD;
&#xD;
          2. FIGO Stage IVB (cancer has spread distantly).&#xD;
&#xD;
          3. Subjects who have undergone a previous hysterectomy defined as removal of the entire&#xD;
             uterus or will have a hysterectomy as part of their initial cervical cancer therapy.&#xD;
&#xD;
          4. Has not achieved at least a partial response by Response Evaluation Criteria in Solid&#xD;
             Tumors (RECIST) v1.1 after completion of CCRT administered with curative intent.&#xD;
&#xD;
          5. Patients previously treated with chemotherapy except when used concurrently with&#xD;
             radiation therapy. Patients who have received either concurrent paclitaxel with&#xD;
             radiation therapy or carboplatin/paclitaxel as adjuvant therapy are ineligible for the&#xD;
             study.&#xD;
&#xD;
          6. Prior treatment with any anti-vascular endothelial growth factor (anti-VEGF) drug,&#xD;
             including bevacizumab, CD137 agonists or immune checkpoint blockade therapies,&#xD;
             anti-PD1, or anti-PDL1 therapeutic antibodies or anti-CTLA 4.&#xD;
&#xD;
          7. Patients with a concomitant malignancy other than non-melanoma skin cancer.&#xD;
&#xD;
          8. History of autoimmune disease&#xD;
&#xD;
          9. History of idiopathic pulmonary fibrosis, organizing pneumonia , drug-induced&#xD;
             pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening&#xD;
             chest CT scan.&#xD;
&#xD;
         10. History of interstitial lung disease.&#xD;
&#xD;
         11. Active tuberculosis.&#xD;
&#xD;
         12. Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1.&#xD;
&#xD;
         13. Administration of a live, attenuated vaccine within 14 days before Cycle 1, Day 1 or&#xD;
             anticipation that such a live attenuated vaccine will be required during the study&#xD;
             Influenza vaccination should be given during influenza season only. Patients must not&#xD;
             receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to&#xD;
             Cycle 1, Day 1 or at any time during the study.&#xD;
&#xD;
         14. Treatment with systemic immunostimulatory agents within 6 weeks or 5 half-lives of the&#xD;
             drug, whichever is shorter, prior to Cycle 1, Day 1.&#xD;
&#xD;
         15. Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1,&#xD;
             Day 1.&#xD;
&#xD;
         16. Women that are breastfeeding or pregnant.&#xD;
&#xD;
         17. Demonstration of any other disease, neurological or metabolic dysfunction, found upon&#xD;
             physical examination or laboratory tests involving a reasonable suspicion of the&#xD;
             existence of a disease or condition that contraindicates the use of an experimental&#xD;
             drug, or that involves an increased risk to the patient of treatment-related&#xD;
             complications.&#xD;
&#xD;
         18. No medical or psychiatric illness that may impede the performance of a systemic or&#xD;
             surgical treatment&#xD;
&#xD;
         19. Participant must not be simultaneously enrolled in any interventional clinical trial&#xD;
&#xD;
         20. Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol&#xD;
             therapy and participant must have recovered from any surgical effects.&#xD;
&#xD;
         21. Participant must not have received investigational therapy ≤ 4 weeks, or within a time&#xD;
             interval less than at least 5 half-lives of the investigational agent, whichever is&#xD;
             shorter, prior initiating protocol therapy.&#xD;
&#xD;
         22. Participant has had radiation therapy encompassing &gt;20% of the bone marrow within 2&#xD;
             weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.&#xD;
&#xD;
         23. Participant must not have a known hypersensitivity to TSR-042 components or&#xD;
             excipients.&#xD;
&#xD;
         24. Participant must not have a serious, uncontrolled medical disorder or nonmalignant&#xD;
             systemic disease. Examples include, but are not limited to, uncontrolled ventricular&#xD;
             arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive&#xD;
             pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord&#xD;
             compression, superior vena cava syndrome, or any psychiatric disorder that prohibits&#xD;
             obtaining informed consent&#xD;
&#xD;
         25. Participant must not have known, symptomatic brain or leptomeningeal metastases&#xD;
&#xD;
         26. Patient experienced ≥ Grade 3 immune-related adverse events (AE) with prior&#xD;
             immunotherapy, with the exception of non-clinically significant lab abnormalities.&#xD;
&#xD;
         27. Participant has a known history of human immunodeficiency virus (type 1 or 2&#xD;
             antibodies).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female patients</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana Oaknin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Vall d'Hebron</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital General Universitario de Elche</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Fe</name>
      <address>
        <city>Valencia</city>
        <state>Comunidad Valenciana</state>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Donostia- Donostia Unibertsitate Ospitalea</name>
      <address>
        <city>Donostia</city>
        <state>Gipuzkoa</state>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Álvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Reina Sofía Cordoba</name>
      <address>
        <city>Cordoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICO Girona</name>
      <address>
        <city>Girona</city>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICO Hospitalet</name>
      <address>
        <city>Hospitalet del Llobregat</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universitaria de Navarra</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Virgen Arrixaca</name>
      <address>
        <city>Murcia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Morales Meseguer</name>
      <address>
        <city>Murcia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Victoria</name>
      <address>
        <city>Málaga</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Son Espases</name>
      <address>
        <city>Palma De Mallorca</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Son Llatzer</name>
      <address>
        <city>Palma De Mallorca</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Parc Taulí</name>
      <address>
        <city>Sabadell</city>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Marqués de Valdecilla</name>
      <address>
        <city>Santander</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Terrassa</name>
      <address>
        <city>Terrassa</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Valenciano de Oncología</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara Oncology Training and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <state>Anadolu Bölgesi</state>
        <zip>06200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara City Hospital</name>
      <address>
        <city>Ankara</city>
        <state>Anadolu Bölgesi</state>
        <zip>06800</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hacettepe University</name>
      <address>
        <city>Ankara</city>
        <state>Anadolu Bölgesi</state>
        <zip>06800</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acibadem Maslak Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Sarıyer</state>
        <zip>34457</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
    <country>Turkey</country>
  </location_countries>
  <removed_countries>
    <country>Romania</country>
  </removed_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TSR-042</keyword>
  <keyword>Anti-PD1</keyword>
  <keyword>advanced cervical cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dostarlimab</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03833479
org study id: GEICO 78-C (ATOMICC)
secondary id: 2018-002155-15
nct id: NCT03833479
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with locally advanced cervical cancer (LACC) despite definitive chemo-radiotherapy,
      has a poor progression-free survival (PFS) and overall survival (OS). The hypothesis is that
      the use of TSR-042, checkpoint inhibitor, as consolidation therapy following concurrent
      chemo-radiation would increase PFS in these patients. The incorporation of immunotherapy
      after chemo-radiation is one the best scenarios for this approach, since takes advantages of
      "the ideal microenvironment" created after radiation. In a similar rationale, the phase 3
      study that compared the anti-programmed death ligand 1 antibody durvalumab as consolidation
      therapy with placebo in patients with stage III NSCLC who did not have disease progression
      after two or more cycles of platinum-based chemoradiotherapy, showed that progression-free
      survival was significantly longer with durvalumab than with placebo in all sub-groups
      regardless of response obtained to chemotherapy, namely patients with stable disease (SD)
      gained the same benefit that patients with partial response (PR). Due to the aforementioned
      biology of cervical cancer, the proven activity of anti programmed cell death protein 1
      (Anti-PD1) agents in metastatic and/or recurrent cervical cancer and the poor PFS and OS in
      patients with LACC despite definitive chemo-radiotherapy, we consider to analyze the Anti-PD1
      agent, TSR-042 as maintenance therapy after concurrent chemo-radiation (CCRT)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival
time frame: 30 months
description: Time from the date of randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first based on investigator assessment using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
measure: Frequency and severity of adverse events (AEs)
time frame: 30 months
description: Incidence, nature and severity of adverse events (AEs) assessed by CTCAE version 4.03
measure: Overall survival (OS)
time frame: 30 months
description: Time from the date of randomization to the date of death due to any cause
measure: Patient reported outcomes (PROs) of health-related quality of life (HRQOL)
time frame: 30 months
description: Mean changes from baseline score assessed by the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx)
measure: Patient reported outcomes (PROs) of health-related quality of life (HRQOL)
time frame: 30 months
description: Mean changes from baseline score assessed by EQ -5D-5L.
measure: Patient reported outcomes (PROs) of fatigue
time frame: 30 months
description: Mean changes from baseline score assessed by the PROMIS-Cancer-Fatigue Short Form 4a.
measure: Patient reported outcomes (PROs) of pain
time frame: 30 months
description: Mean changes from baseline score assessed by a single item of the Brief Pain Inventory (BPI).
arm group label: No further treatment
arm group type: Experimental
description: No further treatment
arm group label: TSR-042
arm group type: Experimental
description: TSR-042 treatment administered using a 30 -minute IV infusion (with a -5 minute and +15 minute window permitted).
intervention type: Other
intervention name: No Further Treatment
description: No further treatment
arm group label: No further treatment
intervention type: Drug
intervention name: TSR-042
description: Fixed 500 mg TSR-042 dose Q3W for the first 4 doses followed by a fixed 1000 mg TSR-042 dose Q6W for up to 24 months
arm group label: TSR-042
criteria: 
gender: Female
gender based: Yes
gender description: Female patients
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ana Oaknin, PhD
role: Principal Investigator
affiliation: Hospital Vall d'Hebron
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country: Spain
country: Turkey
country: Romania
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms
mesh term: Dostarlimab