Description:
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.
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.
Recruiting
Phase 2
Drug | Synonyms | Arms |
---|---|---|
Nivolumab | anti-PD-1, OPDIVO | Cohort 1: Nivolumab and Relatlimab |
Relatlimab | BMS-986016 | Cohort 1: Nivolumab and Relatlimab |
Nivolumab | anti-PD-1, OPDIVO | Cohort 2: Nivolumab and Relatlimab |
Relatlimab | BMS-986016 | Cohort 2: Nivolumab and Relatlimab |
Name | Type | Description | Interventions |
---|---|---|---|
Cohort 1: Nivolumab and Relatlimab | Experimental | 480mg/160mg (co-administered) |
|
Cohort 2: Nivolumab and Relatlimab | Experimental | 480mg/960mg (sequential administration) |
|
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. - 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Number of participants experiencing study drug-related toxicities |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
August 19, 2021