Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer

Prior treatment

• 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:
• 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.

Other illness

• 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.

Other

• Trifluridine-tipiracil, regorafenib, or fruquitinib.

• 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.