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

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Nivolumab

Criteria

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.