NCT07527858
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentGilead Sciences
~170 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:DenikitugNivolumabBevacizumabTrifluridine-Tipiracil
At a glance
Recruiting sites
7 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over Up to 60 months
Conditions
Where it's being run
14 sites across 10 statesSouth Korea4
Massachusetts2
Connecticut1
Missouri1
South Dakota1
Virginia1
CA1
Queensland1
Study leadership
- Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Have adequate organ function.
Exclusion
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).
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.
What this trial measures
- Objective Response Rate (ORR)Up to 60 months
ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST Version 1.1.