Study on Pembrolizumab/Quavonlimab Combination Versus Other Treatments for Advanced Colorectal Cancer with Specific Genetic Features

Inclusion Criteria

• Diagnosed with Stage IV colorectal cancer with specific genetic markers (MSI-H or dMMR).
• Expected to live at least 3 more months.
• Female participants must not be pregnant or breastfeeding and must use effective birth control if they are of childbearing potential.
• Have cancer that can be measured by scans.
• Provide a tumor sample for testing.
• Have good organ function.

Cohort A:

• Previously treated for Stage IV colorectal cancer and the cancer has progressed or the patient could not tolerate standard treatments, which include specific chemotherapy drugs and possibly certain antibodies.

Cohort B:

• Have not received any prior chemotherapy or immunotherapy for Stage IV colorectal cancer.

Exclusion Criteria

• Have received certain types of immune therapies before.
• Have had other cancer treatments or experimental drugs recently.
• Have not fully recovered from surgery or have complications from it.
• Have had recent radiation therapy.
• Have received a live vaccine recently.
• Are participating in another clinical trial or have used experimental devices recently.
• Have immune system deficiencies or are on high doses of steroids or other immune-suppressing drugs.
• Have another active cancer that needs treatment.
• Have cancer that has spread to the brain or spinal cord.
• Have severe allergies to the study drugs.
• Have active autoimmune diseases needing treatment.
• Have a history of lung inflammation needing steroids.
• Have a history of pancreatitis.
• Have muscle disorders with high creatine kinase levels.
• Have high levels of protein in urine.
• Have active infections needing treatment.
• Have HIV or active hepatitis B or C infections.
• Have serious heart conditions.
• Have fluid buildup in the body needing treatment.
• Have any condition that could interfere with the study or is not in the participant's best interest.
• Have psychiatric or substance abuse issues affecting study participation.
• Have had a tissue or organ transplant.