Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer
A Phase 2, Open Label, Multicenter, Randomized Study, to Evaluate the Efficacy and Safety of Denikitug Monotherapy and Denikitug-based Combinations in Participants With Advanced Microsatellite Stable (MSS) Colorectal Cancer (CRC)
2 other identifiers
interventional
170
4 countries
14
Brief Summary
The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy and Denikitug-based Combinations in participants with advanced microsatellite stable (MSS) colorectal cancer (CRC). The primary objective of this study is to assess the effect of DEN as monotherapy and in combination with nivolumab (NIVO) or trifluridine-tipiracil (FTD-TPI) and bevacizumab (BVZ) on objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2026
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2026
CompletedFirst Posted
Study publicly available on registry
April 14, 2026
CompletedStudy Start
First participant enrolled
May 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
July 28, 2026
July 1, 2026
2.5 years
April 7, 2026
July 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
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.
Up to 60 months
Secondary Outcomes (9)
Duration of response (DOR)
Up to 60 months
Progression-Free Survival (PFS)
Up to 60 months
Overall Survival (OS)
Up to 60 months
Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
First dose date up to 120 days post last dose, up to 60 months
Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE v5.0
First dose date up to 120 days post last dose, up to 60 months
- +4 more secondary outcomes
Study Arms (4)
DEN monotherapy (Arm A)
EXPERIMENTALParticipants will receive DEN via intravenous (IV) infusion.
DEN in combination with NIVO (Arm B)
EXPERIMENTALParticipants will receive DEN as an IV infusion in combination with NIVO as an IV infusion.
DEN in combination with Trifluridine-Tipiracil (FTD-TPI) and BVZ (Arm C)
EXPERIMENTALParticipants will receive DEN as an IV infusion in combination with BVZ as an IV infusion and FTD-TPI administered orally. Includes a Safety Run-in cohort (non-randomized cohort) prior to randomization.
Standard of care (SOC) alone: BVZ and FTD-TPI (Arm D)
ACTIVE COMPARATORParticipants will receive BVZ as an IV infusion and FTD-TPI administered orally as SOC.
Interventions
Administered Intravenously
Administered orally
Administered Intravenously
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (14)
Yale-New Haven Hospital - Yale Cancer Center
North Haven, Connecticut, 06473 2195, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
University of Virginia,
Charlottesville, Virginia, 22908, United States
Chris O'Brien Lifehouse
Camperdown, CA, 2050, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Samsung Medical Center
Busan, 48775, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Yonsei University Severance Hospital ( aka Yonsei Cancer Center)
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Hospital General Universitario Gregorio Maranon
Madrid, 28050, Spain
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Central Study Contacts
Gilead Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2026
First Posted
April 14, 2026
Study Start
May 19, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
July 28, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share