<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/NCT03817125</url>
  </required_header>
  <id_info>
    <org_study_id>PICI0014</org_study_id>
    <nct_id>NCT03817125</nct_id>
  </id_info>
  <brief_title>Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention</brief_title>
  <acronym>MCGRAW</acronym>
  <official_title>A Multicenter Phase 1b Randomized, Placebo-controlled, Blinded Study to Evaluate the Safety, Tolerability and Efficacy of Microbiome Study Intervention Administration in Combination With Anti-PD-1 Therapy in Adult Patients With Unresectable or Metastatic Melanoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Parker Institute for Cancer Immunotherapy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seres Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Parker Institute for Cancer Immunotherapy</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 study is designed to evaluate the safety and tolerability of treatment with oral&#xD;
      microbiome study intervention (SER-401) or matching placebo in combination with&#xD;
      anti-programmed cell death 1 (anti-PD-1) therapy (nivolumab) in participants with&#xD;
      unresectable or metastatic melanoma. The study also intends to assess clinical outcomes, the&#xD;
      impact of microbiome study intervention administration on the microbiome profile, and its&#xD;
      association with clinical and immunological outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1b, multicenter, randomized, placebo-controlled, blinded study in adult&#xD;
      participants with anti-PD-1 therapy naïve, unresectable or metastatic melanoma to evaluate&#xD;
      the safety and tolerability of SER-401, or matching placebo in combination with anti-PD-1&#xD;
      therapy (nivolumab). Prior to initiating microbiome study intervention and nivolumab,&#xD;
      participants will undergo an antibiotic or antibiotic placebo treatment lead-in to prime the&#xD;
      gut microbiome for engraftment of the oral microbiome study intervention. Study intervention&#xD;
      groups will be assessed for safety, changes in the microbiome, changes in the percentage of&#xD;
      tumoral CD8 T cells, and antitumor activity. Participants must have measurable disease that&#xD;
      can be biopsied and consent to baseline and on-treatment biopsies, as well as stool and blood&#xD;
      biomarker collection throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 28, 2019</start_date>
  <completion_date type="Actual">March 4, 2022</completion_date>
  <primary_completion_date type="Actual">March 4, 2022</primary_completion_date>
  <phase>Phase 1</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>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Participants will be randomly assigned in a 2:1 ratio to oral microbiome study intervention or matching placebo. Nivolumab will be administered open-label as standard of care to all groups. Investigators, site personnel, and participants will remain blinded to the assignment of microbiome study intervention throughout the course of the study. Select Sponsor personnel, including but not limited to the Medical Monitor, Clinical Scientists, Biostatistician, and Patient Safety, will be unblinded to treatment assignment for ongoing safety monitoring.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients with Adverse Events (AEs)</measure>
    <time_frame>Up to 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determination of the engraftment of SER-401 bacteria in microbiome study intervention group relative to placebo.</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR) at Weeks 24 and 52</measure>
    <time_frame>Up to week 52</time_frame>
    <description>Defined as complete response (CR) or partial response (PR) as best response by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR) at Weeks 24 and 52</measure>
    <time_frame>Up to week 52</time_frame>
    <description>Defined as CR, PR, or stable disease (SD) for ≥ 24 weeks as best response by RECIST v1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS) Progression free survival</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Defined as the time from randomization to date of first documented progression of disease, date of death due to any cause, or date of most recent participant contact that documented progression-free status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival [OS]</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Defined as the time from randomization until death or last contact if still alive at the time of final data collection (after completion of anti-PD-1 therapy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Defined as time from date of documented CR or PR to date of first documented progression of disease, date of death due to any cause, or date of most recent participant contact that documented response (ie, scan date).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the percentage of CD8 cells in tumor tissue from baseline at Cycle 2.</measure>
    <time_frame>At cycle 2 (each cycle is 28 days)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Metastatic Melanoma</condition>
  <arm_group>
    <arm_group_label>SER-401 Matching Placebo/ Nivolumab</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will undergo a 4-day lead-in pretreatment with antibiotic placebo, then matching placebo for SER-401 and nivolumab (480 mg) treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SER-401/ Nivolumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will undergo a 4-day lead-in pretreatment with antibiotic (vancomycin) to prime the gut microbiome for engraftment of the oral microbiome study intervention, then SER-401 and nivolumab treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for antibiotic</intervention_name>
    <description>Placebo for antibiotic will be administered orally four times a day for 4 days, followed by a 2-3 day washout.</description>
    <arm_group_label>SER-401 Matching Placebo/ Nivolumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vancomycin pretreatment</intervention_name>
    <description>Vancomycin (125mg) will be administered orally four times a day, followed by a 2-3 day washout.</description>
    <arm_group_label>SER-401/ Nivolumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Nivolumab (480 mg) will be administered intravenously (IV) according to institutional guidelines every 4 weeks for up to 12 cycles. A cycle is defined as 4 calendar weeks.</description>
    <arm_group_label>SER-401 Matching Placebo/ Nivolumab</arm_group_label>
    <arm_group_label>SER-401/ Nivolumab</arm_group_label>
    <other_name>Opdivo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching Placebo for SER-401</intervention_name>
    <description>Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase.</description>
    <arm_group_label>SER-401 Matching Placebo/ Nivolumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SER-401</intervention_name>
    <description>Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase.</description>
    <arm_group_label>SER-401/ Nivolumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participant must be willing to provide a baseline stool sample.&#xD;
&#xD;
          2. Histologically-confirmed Stage IV cutaneous melanoma or Stage III cutaneous, acral or&#xD;
             mucosal melanoma that is judged inoperable. Participants with a history of uveal&#xD;
             melanoma are not eligible.&#xD;
&#xD;
          3. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version&#xD;
             1.1 (RECIST v1.1; ie, defined as at least 1 lesion that can be accurately measured in&#xD;
             at least 1 dimension [longest diameter to be recorded] with a minimum size of ≥ 10 mm&#xD;
             by computerized tomography [CT] scan or caliper measurement on clinical exam or ≥ 20&#xD;
             mm by chest X-ray).&#xD;
&#xD;
               1. Malignant lymph nodes must be ≥ 15 mm in short axis when assessed by CT scan to&#xD;
                  be considered pathologically enlarged and measurable.&#xD;
&#xD;
               2. Participants must have at least one measurable lesion by RECIST and a separate&#xD;
                  lesion amenable to biopsy that has not been previously irradiated.&#xD;
&#xD;
             i. Participants must be willing to undergo a newly-obtained core needle or incisional&#xD;
             biopsy at baseline (prior to antibiotic or antibiotic placebo administration). Fine&#xD;
             needle aspiration is not acceptable.&#xD;
&#xD;
          4. Participants must be willing to undergo tumor biopsy on treatment.&#xD;
&#xD;
          5. Prior adjuvant or neoadjuvant melanoma therapy is permitted if completed at least 6&#xD;
             weeks prior to randomization and all related AEs have either returned to baseline or&#xD;
             stabilized.&#xD;
&#xD;
               1. Prior anti-CTLA-4 therapy in the adjuvant setting is allowed if completed at&#xD;
                  least 12 weeks prior to the first dose of anti-PD-1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participants who require hemodialysis.&#xD;
&#xD;
          2. Participants with a history of another cancer in the last 5 years, except for: a)&#xD;
             curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma&#xD;
             in situ; c) localized prostate cancer not requiring systemic therapy; and c) other&#xD;
             primary tumors with no known active disease present that, in the opinion of the&#xD;
             Investigator and the Sponsor, will not affect participant outcome in the setting of&#xD;
             the current diagnosis.&#xD;
&#xD;
          3. Any known, untreated brain metastases. Participants with brain metastases are eligible&#xD;
             if these have been treated, and provided:&#xD;
&#xD;
               1. Brain metastases must be stable (image-documented) 4 weeks after completion of&#xD;
                  treatment for brain metastases and require treatment with less than 10 mg/day&#xD;
                  prednisone equivalent for at least 2 weeks prior to study intervention&#xD;
                  administration.&#xD;
&#xD;
               2. Neurological symptoms should be absent or returned to baseline.&#xD;
&#xD;
          4. Prior checkpoint inhibitor therapy with anti-PD-1 or anti-PD-L1 in the adjuvant&#xD;
             setting.&#xD;
&#xD;
             a. Exception: Participants with stage 3 or 4 cutaneous melanoma status post-resection&#xD;
             who have received up to one year of adjuvant anti-PD-1 therapy who have recurred &gt; 6&#xD;
             months after their last dose of anti-PD-1 therapy are eligible.&#xD;
&#xD;
          5. Other prior systemic treatment (ie, anticancer chemotherapy, immunotherapy, or&#xD;
             investigational agents) for unresectable or metastatic melanoma EXCEPT:&#xD;
&#xD;
               1. Prior BRAF-targeted therapy (ie, BRAF or BRAF-MEK) in the metastatic setting is&#xD;
                  allowed if completed at least 4 weeks prior to the first dose of anti-PD-1.&#xD;
&#xD;
               2. Prior anti-CTLA 4 therapy in the adjuvant setting are allowed if completed at&#xD;
                  least 12 weeks prior to the first dose of anti-PD-1.&#xD;
&#xD;
          6. History of active inflammatory bowel disease (eg, active Crohn's disease or ulcerative&#xD;
             colitis) with diarrhea OR major gastrointestinal surgery (not including appendectomy&#xD;
             or cholecystectomy) within 3 months of enrollment (ie, signed informed consent for the&#xD;
             study), OR any history of total colectomy or bariatric surgery (bariatric surgery&#xD;
             which does not disrupt the gastrointestinal lumen, ie, restrictive procedures such as&#xD;
             banding, are permitted).&#xD;
&#xD;
          7. Any diagnosis of autoimmune disease. Participants with Type I diabetes mellitus,&#xD;
             hypothyroidism only requiring hormone replacement, adrenal insufficiency on&#xD;
             replacement dose steroids, skin disorders (such as vitiligo, psoriasis or alopecia)&#xD;
             not requiring systemic treatment, or conditions not expected to recur in the absence&#xD;
             of an external trigger are permitted to enroll.&#xD;
&#xD;
             a. Participants with controlled Type 1 diabetes mellitus on a stable insulin regimen&#xD;
             may be eligible.&#xD;
&#xD;
          8. Has a condition requiring systemic treatment with either corticosteroids (&gt; 10 mg&#xD;
             daily prednisone equivalents) or other immunosuppressive medications within 14 days of&#xD;
             study intervention administration or has a contrast allergy requiring premedication&#xD;
             with corticosteroids. Inhaled or topical steroids, and adrenal replacement doses &gt; 10&#xD;
             mg daily prednisone equivalents are permitted in the absence of active autoimmune&#xD;
             disease.&#xD;
&#xD;
          9. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced),&#xD;
             organizing pneumonia (ie, bronchiolitis obliterans, cryptogenic organizing pneumonia,&#xD;
             etc.), or evidence of active pneumonitis on screening chest CT scan.&#xD;
&#xD;
             a. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.&#xD;
&#xD;
         10. Has a transplanted organ or has undergone allogeneic bone marrow transplant.&#xD;
&#xD;
         11. Has received a live vaccine within 30 days prior to first dose. Participants must not&#xD;
             receive live, attended influenza vaccine (eg, FluMist) within 30 days prior to Cycle&#xD;
             1, Day 1 or at any time during the study and 100 days after last dose of nivolumab.&#xD;
&#xD;
         12. Has used antibiotics within 30 days prior to randomization or has planned or required&#xD;
             need for antibiotic prophylaxis for more than 24 consecutive hours during the course&#xD;
             of the study.&#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>Parker Institute for Cancer Immunotherapy</last_name>
    <role>Study Director</role>
    <affiliation>Parker Institute for Cancer Immunotherapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Angeles Clinic and Research Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.gov/ct2/show/NCT02437487</url>
    <description>NCT02437487: SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)</description>
  </link>
  <link>
    <url>https://clinicaltrials.gov/ct2/show/NCT02530385</url>
    <description>NCT02530385: Fecal Microbiota Transplant for Obesity and Metabolism</description>
  </link>
  <link>
    <url>https://clinicaltrials.gov/ct2/show/NCT02618187</url>
    <description>NCT02618187: A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER- 287 in Subjects With Mild-to-Moderate Ulcerative Colitis Patients</description>
  </link>
  <link>
    <url>https://clinicaltrials.gov/ct2/show/NCT03341143</url>
    <description>NCT03341143: Fecal Microbiota Transplant (FMT) in Melanoma Patients</description>
  </link>
  <link>
    <url>https://clinicaltrials.gov/ct2/show/NCT03353402</url>
    <description>NCT03353402: Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy</description>
  </link>
  <link>
    <url>https://clinicaltrials.gov/ct2/show/NCT03637803</url>
    <description>NCT03637803: MRx0518 and Pembrolizumab Combination Study</description>
  </link>
  <link>
    <url>http://www.opdivohcp.com/?cid=sem_230964&amp;ovl=isi</url>
    <description>Opdivo (nivolumab) US Prescribing Information (USPI), Aug-2018</description>
  </link>
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  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>June 7, 2022</last_update_submitted>
  <last_update_submitted_qc>June 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Metastatic Melanoma</keyword>
  <keyword>anti-PD1</keyword>
  <keyword>Nivolumab</keyword>
  <keyword>Microbiome</keyword>
  <keyword>SER-401</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Vancomycin</mesh_term>
    <mesh_term>Nivolumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 9, 2022</submitted>
  </pending_results>
  <!-- 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/NCT03817125
org study id: PICI0014
nct id: NCT03817125
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is designed to evaluate the safety and tolerability of treatment with oral
      microbiome study intervention (SER-401) or matching placebo in combination with
      anti-programmed cell death 1 (anti-PD-1) therapy (nivolumab) in participants with
      unresectable or metastatic melanoma. The study also intends to assess clinical outcomes, the
      impact of microbiome study intervention administration on the microbiome profile, and its
      association with clinical and immunological outcomes.
This is a Phase 1b, multicenter, randomized, placebo-controlled, blinded study in adult
      participants with anti-PD-1 therapy naïve, unresectable or metastatic melanoma to evaluate
      the safety and tolerability of SER-401, or matching placebo in combination with anti-PD-1
      therapy (nivolumab). Prior to initiating microbiome study intervention and nivolumab,
      participants will undergo an antibiotic or antibiotic placebo treatment lead-in to prime the
      gut microbiome for engraftment of the oral microbiome study intervention. Study intervention
      groups will be assessed for safety, changes in the microbiome, changes in the percentage of
      tumoral CD8 T cells, and antitumor activity. Participants must have measurable disease that
      can be biopsied and consent to baseline and on-treatment biopsies, as well as stool and blood
      biomarker collection throughout the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Participants will be randomly assigned in a 2:1 ratio to oral microbiome study intervention or matching placebo. Nivolumab will be administered open-label as standard of care to all groups. Investigators, site personnel, and participants will remain blinded to the assignment of microbiome study intervention throughout the course of the study. Select Sponsor personnel, including but not limited to the Medical Monitor, Clinical Scientists, Biostatistician, and Patient Safety, will be unblinded to treatment assignment for ongoing safety monitoring.
measure: Percentage of patients with Adverse Events (AEs)
time frame: Up to 2 years
measure: Determination of the engraftment of SER-401 bacteria in microbiome study intervention group relative to placebo.
time frame: Up to 2 years
measure: Objective response rate (ORR) at Weeks 24 and 52
time frame: Up to week 52
description: Defined as complete response (CR) or partial response (PR) as best response by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 assessment.
measure: Disease control rate (DCR) at Weeks 24 and 52
time frame: Up to week 52
description: Defined as CR, PR, or stable disease (SD) for ≥ 24 weeks as best response by RECIST v1.1.
measure: Progression-free survival (PFS) Progression free survival
time frame: Up to 2 years
description: Defined as the time from randomization to date of first documented progression of disease, date of death due to any cause, or date of most recent participant contact that documented progression-free status
measure: Overall survival [OS]
time frame: Up to 2 years
description: Defined as the time from randomization until death or last contact if still alive at the time of final data collection (after completion of anti-PD-1 therapy).
measure: Duration of response
time frame: Up to 2 years
description: Defined as time from date of documented CR or PR to date of first documented progression of disease, date of death due to any cause, or date of most recent participant contact that documented response (ie, scan date).
measure: Change in the percentage of CD8 cells in tumor tissue from baseline at Cycle 2.
time frame: At cycle 2 (each cycle is 28 days)
arm group label: SER-401 Matching Placebo/ Nivolumab
arm group type: Placebo Comparator
description: Participants will undergo a 4-day lead-in pretreatment with antibiotic placebo, then matching placebo for SER-401 and nivolumab (480 mg) treatment.
arm group label: SER-401/ Nivolumab
arm group type: Experimental
description: Participants will undergo a 4-day lead-in pretreatment with antibiotic (vancomycin) to prime the gut microbiome for engraftment of the oral microbiome study intervention, then SER-401 and nivolumab treatment.
intervention type: Drug
intervention name: Placebo for antibiotic
description: Placebo for antibiotic will be administered orally four times a day for 4 days, followed by a 2-3 day washout.
arm group label: SER-401 Matching Placebo/ Nivolumab
intervention type: Drug
intervention name: Vancomycin pretreatment
description: Vancomycin (125mg) will be administered orally four times a day, followed by a 2-3 day washout.
arm group label: SER-401/ Nivolumab
intervention type: Drug
intervention name: Nivolumab
description: Nivolumab (480 mg) will be administered intravenously (IV) according to institutional guidelines every 4 weeks for up to 12 cycles. A cycle is defined as 4 calendar weeks.
arm group label: SER-401 Matching Placebo/ Nivolumab
arm group label: SER-401/ Nivolumab
other name: Opdivo
intervention type: Drug
intervention name: Matching Placebo for SER-401
description: Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase.
arm group label: SER-401 Matching Placebo/ Nivolumab
intervention type: Drug
intervention name: SER-401
description: Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase.
arm group label: SER-401/ Nivolumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Parker Institute for Cancer Immunotherapy
role: Study Director
affiliation: Parker Institute for Cancer Immunotherapy
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://clinicaltrials.gov/ct2/show/NCT02437487
description: NCT02437487: SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)
url: https://clinicaltrials.gov/ct2/show/NCT02530385
description: NCT02530385: Fecal Microbiota Transplant for Obesity and Metabolism
url: https://clinicaltrials.gov/ct2/show/NCT02618187
description: NCT02618187: A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER- 287 in Subjects With Mild-to-Moderate Ulcerative Colitis Patients
url: https://clinicaltrials.gov/ct2/show/NCT03341143
description: NCT03341143: Fecal Microbiota Transplant (FMT) in Melanoma Patients
url: https://clinicaltrials.gov/ct2/show/NCT03353402
description: NCT03353402: Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy
url: https://clinicaltrials.gov/ct2/show/NCT03637803
description: NCT03637803: MRx0518 and Pembrolizumab Combination Study
url: http://www.opdivohcp.com/?cid=sem_230964&ovl=isi
description: Opdivo (nivolumab) US Prescribing Information (USPI), Aug-2018
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responsible party type: Sponsor
mesh term: Melanoma
mesh term: Anti-Bacterial Agents
mesh term: Vancomycin
mesh term: Nivolumab
sharing ipd: Undecided
submitted: November 9, 2022