Clinical Trials /

Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer

NCT03642067

Description:

The purpose of this study is to evaluate the safety and clinical activity of nivolumab and relatlimab in patients with metastatic or locally advanced microsatellite stable (MSS) colorectal cancer.

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer
  • Official Title: Phase A Phase 2 Study Evaluating Response and Biomarkers in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer Treated With Nivolumab in Combination With Relatlimab

Clinical Trial IDs

  • ORG STUDY ID: J18119
  • SECONDARY ID: IRB00173537, CA224-068
  • NCT ID: NCT03642067

Conditions

  • Microsatellite Stable (MSS) Colorectal Adenocarcinomas
  • Colorectal Adenocarcinoma

Interventions

DrugSynonymsArms
Nivolumabanti-PD-1, OPDIVONivolumab and Relatlimab
RelatlimabBMS-986016Nivolumab and Relatlimab

Purpose

The purpose of this study is to evaluate the safety and clinical activity of nivolumab and relatlimab in patients with metastatic or locally advanced microsatellite stable (MSS) colorectal cancer.

Trial Arms

NameTypeDescriptionInterventions
Nivolumab and RelatlimabExperimentalPatients will receive treatment every 28 days for up to 2 years. Nivolumab (480 mg) will be administered IV on day 1 (28 day cycle). Relatlimab (160 mg) will be administered IV on day 1 (28 day cycle).
  • Nivolumab
  • Relatlimab

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥18 years.

          -  ECOG performance status 0 or 1

          -  Have metastatic or locally advanced microsatellite stable (MSS) colorectal
             adenocarcinoma.

          -  Must have received at least one chemotherapy regimen.

          -  Patients with the presence of at least one measurable lesion using RECIST 1.1.

          -  Patients must have available archival tissue from the surgical resection of their
             primary tumor.

          -  Patient's acceptance of tumor biopsies.

          -  Life expectancy of greater than 3 months.

          -  Patients must have adequate organ and marrow function defined by study - specified
             laboratory tests.

          -  Documented LVEF ≥ 50% - 6 month prior to drug administration.

          -  Must use acceptable form of birth control while on study.

          -  Ability to understand and willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Known history or evidence of brain metastases.

          -  Require any antineoplastic therapy.

          -  History of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or
             anti-Lag-3 antibodies.

          -  Had chemotherapy, radiation, or steroids within 14 days prior to study treatment.

          -  Hypersensitivity reaction to any monoclonal antibody.

          -  Has uncontrolled intercurrent acute or chronic medical illness.

          -  Has an active known or suspected autoimmune disease.

          -  Has a diagnosis of immunodeficiency.

          -  Prior tissue or organ allograft or allogeneic bone marrow transplantation.

          -  Requires daily supplemental oxygen

          -  History of interstitial lung disease.

          -  Significant heart disease

          -  History of encephalitis, meningitis, or uncontrolled seizures in the year prior to
             informed consent.

          -  Infection with HIV or hepatitis B or C at screening.

          -  Has an active infection.

          -  Unable to have blood drawn.

          -  Patient with uncontrolled intercurrent illness including, but not limited to,
             uncontrolled infection, symptomatic congestive heart failure, unstable angina
             pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
             limit compliance with study requirements.

          -  Woman who are pregnant or breastfeeding.
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:4 years
Safety Issue:
Description:The proportion of subjects with partial response (PR) or complete response (CR) according to RECIST 1.1.

Secondary Outcome Measures

Measure:Number of participants experiencing study drug-related toxicities
Time Frame:4 years
Safety Issue:
Description:Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0
Measure:Overall survival (OS)
Time Frame:4 years
Safety Issue:
Description:Number of months from the date of first treatment until death or end of follow-up.
Measure:Progression free survival (PFS)
Time Frame:4 years
Safety Issue:
Description:Number of months from treatment to disease progression (PD) or relapse from complete response (CR) as assessed using RECIST 1.1 criteria, or death due to any cause.
Measure:Time to Progression (TTP)
Time Frame:4 years
Safety Issue:
Description:Number of months from the date of first treatment to the date of documented disease progression (PD or relapse from CR as assessed using RECIST 1.1 criteria).
Measure:Disease control rate (DCR)
Time Frame:4 years
Safety Issue:
Description:Percentage of participants achieving stable disease (SD) or better (SD + partial response (PR) + CR).
Measure:Best overall response (BOR)
Time Frame:4 years
Safety Issue:
Description:Best response recorded from the start of the treatment until disease progression/recurrence per RECIST 1.1 criteria.
Measure:Duration of response (DOR)
Time Frame:4 years
Safety Issue:
Description:Number of months from the first documentation of a response to date of disease progression.
Measure:Duration of clinical benefit (DCB)
Time Frame:4 years
Safety Issue:
Description:Number of months from the date of first treatment to date of disease progression in those achieving a PR or CR.
Measure:Time to objective response (TTOR)
Time Frame:4 years
Safety Issue:
Description:Number of months from the date of first treatment to the date of documented partial or complete response.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Trial Keywords

  • Relatlimab
  • Nivolumab
  • Immunotherapy
  • Anti-PD-1
  • Anti-LAG-3
  • Antibody
  • MSS
  • PD-L1
  • Microsatellite stability
  • Colorectal cancer
  • Colon cancer
  • Rectal cancer

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