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RecruitingPhase 2

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests denikitug alone or with nivolumab or the drugs trifluridine-tipiracil and bevacizumab. It is for adults with advanced colorectal cancer that is microsatellite stable (MSS), a type found through lab tests. Researchers will check safety and whether treatment shrinks tumors.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have colorectal adenocarcinoma, a cancer that starts in gland cells, confirmed by a tissue or cell test. Appendix cancer does not qualify.
  • The cancer cannot be removed by surgery, has come back, has grown into nearby areas, or has spread to other parts of the body.
  • Lab tests must show MSS or pMMR cancer, meaning certain DNA repair problems are not found.
  • Have had no more than 2 courses of drug treatment for advanced cancer. These must include fluoropyrimidine, oxaliplatin, and irinotecan when needed, plus certain other drugs if they apply to your cancer.
  • CT or MRI scans must show that the cancer grew during or after your most recent treatment.
  • Be fully active or able to walk and do light work, even if you cannot do hard physical activity.
  • Your organs must work well enough for the study.

Who can't join

  • Have serious heart or blood vessel disease.
  • Have a history of autoimmune disease, where the immune system attacks the body, or active autoimmune disease that needed whole-body treatment within 2 years.
  • Have current or past lung inflammation or lung tissue disease not caused by an infection.
  • Have had a hole in the stomach or bowel, a permanent opening to drain small-bowel waste, a pocket of infection in the belly, or an abnormal tunnel between organs within 6 months; uncontrolled gut bleeding within 4 weeks; or a high risk of bleeding or a hole in the gut.
  • Have taken trifluridine-tipiracil, regorafenib, or fruquintinib.
  • Have had any cancer treatment that works through the immune system.
  • Have had a biologic cancer drug within 4 weeks before study group assignment; or chemotherapy, a targeted small-molecule drug, or radiation within 2 weeks and have not recovered enough from past treatment side effects.
  • Have received donor tissue, an organ, or stem cells. A past cornea transplant is allowed if you do not need whole-body drugs to weaken your immune system.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study sites (6)

CT

MA

MO

SD

VA