No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
170 (estimated)
Sponsor
Gilead Sciences · Industry
Who this trial is looking for
This trial is looking for adults with advanced colorectal cancer that cannot be cured by surgery. Participants will take the study drug Denikitug alone or in combination with other treatments to see how well it works.
Are You a Good Fit for This Trial?
Must not be takingTrifluridine-tipiracilRegorafenibFruquitinibImmuno-oncology therapy
Rules you outAutoimmune diseaseCardiovascular disease
You may be able to join if
I have been diagnosed with advanced microsatellite stable colorectal cancer.
I have had up to 2 prior treatments for my cancer.
I have documented progressive disease after my last treatment.
I have an ECOG performance status score of 0-1.
I have adequate organ function.
You may not be able to join if
I have significant cardiovascular disease.
I have a history of autoimmune disease that required treatment in the past 2 years.
I have had noninfectious pneumonitis or current lung disease.
I have had gastrointestinal bleeding or other serious GI conditions recently.
I have taken certain anticancer treatments or therapies recently.
I have had an organ transplant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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 Locations
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Eligibility Criteria
Key Inclusion Criteria:
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 mism…
Key Inclusion Criteria:
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.
Key Exclusion Criteria with:
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 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.
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