Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer (NCT07527858)
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)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Yale-New Haven Hospital - Yale Cancer Center — North Haven, Connecticut
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- Yale-New Haven Hospital - Yale Cancer Center — North Haven, Connecticut
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Washington University School of Medicine — St Louis, Missouri
- Avera Cancer Institute — Sioux Falls, South Dakota
- University of Virginia, — Charlottesville, Virginia
- Chris O'Brien Lifehouse — Camperdown, CA
- Royal Brisbane and Women's Hospital — Herston, Queensland
- Peter MacCallum Cancer Centre — Melbourne, Victoria
- Samsung Medical Center — Busan,
- Seoul National University Hospital — Seoul,
- Yonsei University Severance Hospital ( aka Yonsei Cancer Center) — Seoul,
- Asan Medical Center — Seoul,
- Hospital General Universitario Gregorio Maranon — Madrid,
📞 Contact the Study Coordinator
Phone: 1-833-445-3230 (GILEAD-0)
Email: GileadClinicalTrials@gilead.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Advanced Microsatellite Stable Colorectal Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.