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

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
Overall Status
Recruiting
CT.gov ID
NCT03642067
Collaborator
Bristol-Myers Squibb (Industry)
96
1
3
59.6
1.6

Study Details

Study Description

Brief Summary

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 12, 2019
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort A/B: Nivolumab and Relatlimab

480mg/160mg (co-administered)

Drug: Nivolumab
Patients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).
Other Names:
  • anti-PD-1, OPDIVO
  • Drug: Relatlimab
    Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).
    Other Names:
  • BMS-986016
  • Experimental: Cohort C: Nivolumab and Relatlimab

    480mg/ 960mg or 480mg/480mg (sequential administration)

    Drug: Nivolumab
    Patients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).
    Other Names:
  • anti-PD-1, OPDIVO
  • Drug: Relatlimab
    Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).
    Other Names:
  • BMS-986016
  • Experimental: Cohort C: Nivolumab and Relatlimab (co-administration)

    480mg/160mg (co-administration)

    Drug: Nivolumab
    Patients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).
    Other Names:
  • anti-PD-1, OPDIVO
  • Drug: Relatlimab
    Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).
    Other Names:
  • BMS-986016
  • Outcome Measures

    Primary Outcome Measures

    1. Cohort A/B: Objective response rate (ORR) [4 years]

      The proportion of subjects with partial response (PR) or complete response (CR) according to RECIST 1.1.

    2. Cohort C: Objective response rate (ORR) [4 years]

      The proportion of subjects with partial response (PR) or complete response (CR) according to RECIST 1.1.

    Secondary Outcome Measures

    1. Number of participants experiencing study drug-related toxicities [4 years]

      Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age ≥18 years.

    • ECOG performance status 0 or 1

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

    • Cohort A: Primary lesion has a composite PD-L1/Mucin (CPM) score ≥ 15%.

    • Cohort B: Primary lesion has a composite PD-L1/Mucin (CPM) score < 15%.

    • Cohort C: Prior surgical resection of primary tumor. Prospective biomarker evaluation not required.

    • 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. Patients with previously treated brain metastases may participate if they are stable for 4 weeks prior to beginning treatment, have no new or enlarging brain metastases, and are not using steroids for at least 1 week prior to initiation of study treatment.

    • 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.

    • Had any cytotoxic drug within 4 weeks prior to initiation of 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.

    • Requires daily supplemental oxygen.

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland United States 21231

    Sponsors and Collaborators

    • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Bristol-Myers Squibb

    Investigators

    • Principal Investigator: Dung Le, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    ClinicalTrials.gov Identifier:
    NCT03642067
    Other Study ID Numbers:
    • J18119
    • IRB00173537
    • CA224-068
    First Posted:
    Aug 22, 2018
    Last Update Posted:
    Mar 16, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 16, 2022