Advanced Microsatellite Stable Colorectal CancerPhase 2NCT07527858
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer
A Phase 2 study testing Denikitug, Nivolumab and Bevacizumab in people with Advanced Microsatellite Stable Colorectal Cancer, run by Gilead Sciences at 15 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Microsatellite Stable Colorectal Cancer
- What is being tested?
- Denikitug, Nivolumab and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 19 May 2026to Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
15 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
15 sites in 4 countries
United States6 sites, 5 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Active, not recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
University of Virginia,
Charlottesville, Virginia, 22908
- Recruiting
Yale-New Haven Hospital - Yale Cancer Center
North Haven, Connecticut, 06473 2195
- Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
- Not yet recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Australia4 sites, 4 recruiting
- Recruiting
Chris O'Brien Lifehouse
Camperdown, CA, 2050
- Recruiting
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
- Recruiting
Royal North Shore Hospital
Saint Leonards, Queensland, 2065
South Korea4 sites, 4 recruiting
- Not yet recruiting
Samsung Medical Center
Busan, 48775
- Not yet recruiting
Seoul National University Hospital
Seoul, 03080
- Not yet recruiting
Yonsei University Severance Hospital ( aka Yonsei Cancer Center)
Seoul, 03722
- Not yet recruiting
Asan Medical Center
Seoul, 138-736
Spain1 site, 1 recruiting
- Not yet recruiting
Hospital General Universitario Gregorio Maranon
Madrid, 28050
About this study
Official title: 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)
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).
- Being tested
- Denikitug, Nivolumab, Bevacizumab, Trifluridine-Tipiracil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenikitugDrug
Also called GS-1811, DEN
Administered Intravenously
NivolumabDrug
Also called NIVO
Administered Intravenously
BevacizumabDrug
Also called BVZ
Administered Intravenously
Trifluridine-TipiracilDrug
Also called FTD-TPI
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| DEN monotherapy (Arm A) | Experimental | Participants will receive DEN via intravenous (IV) infusion. Receives: Drug: Denikitug |
| DEN in combination with NIVO (Arm B) | Experimental | Participants will receive DEN as an IV infusion in combination with NIVO as an IV infusion. Receives: Drug: Denikitug; Drug: Nivolumab |
| DEN in combination with Trifluridine-Tipiracil (FTD-TPI) and BVZ (Arm C) | Experimental | Participants 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. Receives: Drug: Denikitug; Drug: Bevacizumab; Drug: Trifluridine-Tipiracil |
| Standard of care (SOC) alone: BVZ and FTD-TPI (Arm D) | Active comparator | Participants will receive BVZ as an IV infusion and FTD-TPI administered orally as SOC. Receives: Drug: Bevacizumab; Drug: Trifluridine-Tipiracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 60 months
Secondary outcomes (9)
Duration of response (DOR)
DOR is defined as the time from first response (CR or PR) as assessed by investigator, per RECIST Version 1.1 until the date of first documented progressive disease (PD) or death, whichever comes first.
Measured: Up to 60 months
Progression-Free Survival (PFS)
PFS is defined as the time from date of randomization until PD or death from any cause, whichever comes first as assessed by the investigator according to RECIST Version 1.1.
Measured: Up to 60 months
Overall Survival (OS)
OS is defined as the length of time from randomization until the date of death from any cause.
Measured: 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
Measured: 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
Measured: First dose date up to 120 days post last dose, up to 60 months
Pharmacokinetic (PK) Parameter: Serum concentration of Denikitug
Measured: Up to 36 months
PK Parameter: Cmax for Denikitug
Cmax is defined as the maximum observed concentration.
Measured: Up to 36 months
PK Parameter: AUCall for Denikitug
AUCall is defined as the cumulative areas under the curve for all time points.
Measured: Up to 36 months
Percentage of Participants who Developed Antidrug Antibody (ADA) Against Denikitug
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start19 May 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Microsatellite Stable Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527858
- Sponsor's protocol ID
- GS-US-741-7756
- Other IDs
- 2025-523984-39, 2025
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No