TriangleThe film gives the main points. The full list below is copied from the registry; the study team makes the final decision.
- Age18 Years to no maximum
- SexAll
- Healthy volunteersNo
You may be able to join if
- Key Inclusion Criteria:
- Medical History/Physical Characteristics
- Histologically or cytologically confirmed unresectable, recurrent, or locally advanced or metastatic microsatellite stable colorectal cancer (MSS CRC) (adenocarcinoma, excluding appendix cancer).
- Documented MSS or proficient mismatch repair (pMMR) disease by local assessment using a validated polymerase chain reaction (PCR) (microsatellite status) and/or immunohistochemistry (IHC) mismatch repair (MMR) assay is required.
- Has received up to 2 prior lines of systemic therapy for advanced or metastatic CRC, which must have included at least fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapies if indicated; and if applicable: anti-vascular endothelial growth factor (VEGF) therapy, anti epidermal growth factor receptor (EGFR) therapy, encorafenib or adagrasib/sotorasib.
- Documented progressive disease (PD) by computed tomography (CT) or magnetic resonance imaging (MRI) during or after the most recent therapy per RECIST Version 1.1 criteria by investigator assessment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Laboratory Assessments
- Have adequate organ function.
- Key Exclusion Criteria with:
- Medical Conditions/History:
- Significant cardiovascular disease.
- History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years.
- History of (noninfectious) pneumonitis/interstitial lung disease or current pneumonitis/ interstitial lung disease.
- History of gastrointestinal (GI) perforation, permanent ileostomy, abdominal abscess or fistula within 6 months, active or uncontrolled GI bleeding within 4 weeks, or any condition associated with significant risk of bleeding or perforation (eg, untreated varices, tumor erosion, recent GI surgery).
- Prior/Concurrent Therapy or Clinical Study Experience
- Prior treatment with:
- Trifluridine-tipiracil, regorafenib, or fruquitinib.
- Any immuno-oncology therapy.
- Anticancer biologic agent within 4 weeks prior to randomization or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to randomization and have not recovered (ie, Grade 2 or higher is considered not recovered) from AEs from prior anticancer therapy at the time of randomization. Individuals in observational studies are eligible.
- Allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation. Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.