Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Denikitug: Administered Intravenously
Nivolumab: Administered Intravenously
Bevacizumab: Administered Intravenously
Trifluridine-Tipiracil: Administered orally
Study summary
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).
Eligibility
Primary outcome measure(s)
- Objective Response Rate (ORR) — Up to 60 months
ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST Version 1.1.
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Yale-New Haven Hospital - Yale Cancer Center | North Haven | Connecticut | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | Active Not Recruiting |
| Washington University School of Medicine | St Louis | Missouri | Not Yet Recruiting |
| Avera Cancer Institute | Sioux Falls | South Dakota | Recruiting |
| University of Virginia, | Charlottesville | Virginia | Recruiting |
| Chris O'Brien Lifehouse | Camperdown | CA | Recruiting |
| Royal Brisbane and Women's Hospital | Herston | Queensland | Recruiting |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | Recruiting |
| Samsung Medical Center | Busan | South Korea | Not Yet Recruiting |
| Seoul National University Hospital | Seoul | South Korea | Not Yet Recruiting |
| Yonsei University Severance Hospital ( aka Yonsei Cancer Center) | Seoul | South Korea | Not Yet Recruiting |
| Asan Medical Center | Seoul | South Korea | Not Yet Recruiting |
| Hospital General Universitario Gregorio Maranon | Madrid | Spain | Not Yet Recruiting |
More Gilead Sciences trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07527858 on ClinicalTrials.gov ↗ ← All trials in Australia