Study on Nivolumab and Relatlimab for Advanced Cancers Resistant to Previous PD-(L)1 Treatment

Inclusion Criteria

• Must be 18 years or older.
• Have a good overall health status, able to carry out daily activities with minimal restrictions.
• Have advanced or metastatic cancer with a specific genetic feature called mismatch repair deficiency or MSI-H.
• Must have previously been treated with PD-1 or PD-L1 inhibitors.
• Have at least one tumor that can be measured by scans.
• Expected to live for more than 3 months.
• Have adequate organ and bone marrow function based on specific lab tests.
• Heart function must be normal, with a pumping ability of 50% or higher, checked within the last 6 months.
• Must agree to use effective birth control during the study.
• Able to understand and willing to sign a consent form to participate.

Exclusion Criteria

• Have a history or current evidence of cancer spread to the brain.
• Need any cancer treatment other than the study drugs.
• Have been treated with anti-LAG3 drugs before.
• Have had chemotherapy, radiation, or steroids within 14 days before starting the study.
• Have taken any experimental cancer drugs within 4 weeks before the study.
• Have received any experimental drugs, live vaccines, allergy shots, growth factors, or major surgery within 28 days before the study.
• Have had major surgery recently.
• Have allergies to any monoclonal antibody drugs.
• Have an active or suspected autoimmune disease.
• Have a diagnosis of immune system deficiency.
• Have had a tissue or organ transplant or bone marrow transplant from another person.
• Need daily oxygen support.
• Have a history of lung disease affecting the tissue between the air sacs.
• Have significant heart disease.
• Have had brain inflammation, meningitis, or uncontrolled seizures in the past year.
• Have an active infection with HIV, hepatitis B, or hepatitis C.
• Have any active infection.
• Unable to have blood drawn for tests.
• Have uncontrolled health issues, such as severe infections, heart failure, unstable chest pain, irregular heartbeats, or mental health conditions that would interfere with the study.
• Have had severe side effects from previous treatments with PD-1, PD-L1, PD-L2, or CTLA4 inhibitors.
• Are pregnant or breastfeeding.