Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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:
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:
|
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:
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:
|
Outcome Measures
Primary Outcome Measures
- Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [4 years]
Secondary Outcome Measures
- Number of participants experiencing study drug-related toxicities [4 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years.
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Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
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Have metastatic or locally advanced mismatch repair deficient/MSI-H disease.
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Patients must have received prior PD-1/PD-L1 inhibitor therapy
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Patients with the presence of at least one measurable lesion.
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Life expectancy of greater than 3 months.
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Patients must have adequate organ and marrow function defined by study - specified laboratory tests.
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Documented left ventricular ejection fraction (LVEF) ≥ 50% - 6 month prior to drug administration.
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Must use acceptable form of birth control while on study.
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Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
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Known history or evidence of brain metastases.
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Require any antineoplastic therapy.
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History of prior treatment with anti-LAG3.
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Had chemotherapy, radiation, or steroids within 14 days prior to study treatment.
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Had any investigational cytotoxic drug within 4 weeks prior to study treatment.
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Have received any investigational drugs, a live vaccine, any allergen hyposensitization therapy, growth factors or major surgery within 28 days prior to study treatment.
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Major surgery
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Hypersensitivity reaction to any monoclonal antibody.
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Has an active known or suspected autoimmune disease.
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Has a diagnosis of immunodeficiency.
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Prior tissue or organ allograft or allogeneic bone marrow transplantation.
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Requires daily supplemental oxygen
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History of interstitial lung disease.
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Significant heart disease
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History of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent.
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Infection with HIV or hepatitis B or C at screening.
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Has an active infection.
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Unable to have blood drawn.
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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.
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Prior life-threatening toxicity to anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4
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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.- J18102
- IRB00173534