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