Phase 2 study for people with Colorectal Cancer

Reproduced exactly, unedited. Written for researchers rather than for patients.

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 less) 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.