Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
Overall Status
Recruiting
CT.gov ID
NCT03607890
Collaborator
Bristol-Myers Squibb (Industry)
42
1
2
58.5
0.7

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 microsatellite instability high (MSI-H) solid tumors refractory to prior PD-(L)1 therapy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 2 Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor
Actual Study Start Date :
Nov 16, 2018
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1: 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 2: Nivolumab and Relatlimab

    480mg/960mg or 480mg/160mg (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
  • Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [4 years]

    Secondary Outcome Measures

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

    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.

    • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

    • Have metastatic or locally advanced mismatch repair deficient/MSI-H disease.

    • Patients must have received prior PD-1/PD-L1 inhibitor therapy

    • Patients with the presence of at least one measurable lesion.

    • Life expectancy of greater than 3 months.

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

    • Documented left ventricular ejection fraction (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-LAG3.

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

    • Had any investigational cytotoxic drug within 4 weeks prior to study treatment.

    • Have received any investigational drugs, a live vaccine, any allergen hyposensitization therapy, growth factors or major surgery within 28 days prior to study treatment.

    • Major surgery

    • Hypersensitivity reaction to any monoclonal antibody.

    • 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.

    • Prior life-threatening toxicity to anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4

    • 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, Johns Hopkins Medical Institution

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    ClinicalTrials.gov Identifier:
    NCT03607890
    Other Study ID Numbers:
    • J18102
    • IRB00173534
    First Posted:
    Jul 31, 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