MSI-H Tumors Clinical Trial
Official title:
Phase 2 Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor
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.
| Status | Recruiting |
| Enrollment | 42 |
| Est. completion date | October 2024 |
| Est. primary completion date | October 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Bristol-Myers Squibb, National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | 4 years | ||
| Secondary | Number of participants experiencing study drug-related toxicities | 4 years |