Study on Isunakinra and Pembrolizumab for Colorectal Cancer

Inclusion Criteria

• Have a confirmed diagnosis of colorectal cancer.
• The cancer must be RAS-mutated and microsatellite stable, with a high tumor mutational burden.
• Must have measurable disease based on scans.
• Have tried at least one previous treatment for metastatic cancer without success.
• Must wait at least 2 weeks after chemotherapy or radiation, and 4 weeks after immunotherapy, before starting the study.
• Must have recovered from any significant side effects of previous treatments.
• Be in good overall health with a performance status of 0 or 1.
• Have normal organ function and blood counts.
• Have good oxygen levels in the blood.

Exclusion Criteria

• Pregnant or breastfeeding women.
• Currently receiving other cancer treatments, unless specified in the inclusion criteria.
• Have any significant health issues that could affect treatment.
• Have mental health conditions that prevent understanding the study.
• Have active autoimmune diseases requiring treatment, except for stable conditions like vitiligo or alopecia.
• Using systemic steroids, except for specific low-dose uses.
• Participating in another clinical trial within 28 days before starting this study.
• Have untreated or recently treated brain metastases.
• Have severe allergies to pembrolizumab or similar drugs.
• Have serious or uncontrolled illnesses, such as heart problems or infections.
• HIV-positive patients.
• Unwilling to use effective contraception during and after the study.