Denikitug (GS-1811) given alone or with nivolumab or with chemotherapy for advanced colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial evaluating Denikitug as a single agent and in combination with nivolumab or with trifluridine-tipiracil and bevacizumab for adults with unresectable, recurrent, or metastatic MSS colorectal cancer. Participants may have received up to two prior systemic therapies. Primary outcomes include objective response rate by RECIST 1.1 assessed by investigators. The study investigates safety and the potential added benefit of combinations with immune and anti-angiogenic/chemotherapy partners. Sites include Yale New Haven, Beth Israel Deaconess, and Dana-Farber Cancer Institute in the US.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yale-New Haven Hospital - Yale Cancer Center
  North Haven, Connecticut, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• Avera Cancer Institute
  Sioux Falls, South Dakota, United States Recruiting
• University of Virginia,
  Charlottesville, Virginia, United States Recruiting
• Chris O'Brien Lifehouse
  Camperdown, Ca, Australia Recruiting
• Royal Brisbane and Women's Hospital
  Herston, Queensland, Australia Recruiting

Study contacts

• Study coordinator: Gilead Clinical Study Information Center
• Email: GileadClinicalTrials@gilead.com
• Phone: 1-833-445-3230 (GILEAD-0)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.