Denikitug alone or with other medicines for advanced microsatellite stable colorectal cancer
Tests denikitug, alone or combined, in adults with advanced microsatellite stable colorectal cancer.
Plain-language title generated from the registry record
Registry title: Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer
Key facts
- Where
- Madrid, SpainSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced colorectal cancer of the microsatellite stable type whose cancer has grown after earlier treatment.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Colorectal cancer (adenocarcinoma) that cannot be removed by surgery, has come back, or has spread, and is microsatellite stable (MSS) or mismatch repair proficient (pMMR). The cancer must have grown on a scan during or after the last treatment. Appendix cancer is excluded.
- Earlier treatment
- Up to 2 earlier lines of treatment for advanced disease, including the usual chemotherapies if indicated (fluoropyrimidine, oxaliplatin, irinotecan). Anti-VEGF, anti-EGFR, encorafenib or adagrasib/sotorasib if they apply. No earlier trifluridine-tipiracil, regorafenib, fruquitinib or immunotherapy.
- Biomarker or test result
- MSS or pMMR status shown by a PCR test and/or an immunohistochemistry test
Main reasons for not taking part
- Significant heart or blood vessel disease
- Autoimmune disease needing systemic treatment within 2 years
- Past or current pneumonitis or interstitial lung disease
- Gut perforation, fistula or abscess within 6 months, or active or uncontrolled gut bleeding within 4 weeks
- Earlier organ or stem cell transplant from a donor (a corneal transplant without immune-suppressing drugs is allowed)
Read by machine on 9 November 2026.
Where in Spain
- Hospital General Universitario Gregorio MarañónMadrid, SpainNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gilead Sciences
- Trial code
- NCT07527858
- Record updated
- 20 October 2026
- Original description
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 full original descriptionShow less
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).
Inclusion: 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.
Exclusion: 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; 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; Trifluridine-tipiracil, regorafenib, or fruquitinib.