Recruiting nowPhase 2Randomised
| Registry number | NCT07527858 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 170 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Gilead Sciences |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Denikitug
- Drug Nivolumab
- Drug Bevacizumab
- Drug Trifluridine-Tipiracil
What it is measuring
Objective Response Rate (ORR)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
What this trial is trying to do
The researchers are testing denikitug, an antibody intended to remove immune-suppressing regulatory T cells from tumours, either alone or with nivolumab, which releases a brake on T cells, or with trifluridine–tipiracil and bevacizumab chemotherapy. The idea is that changing the tumour’s immune environment may help these treatments work in advanced microsatellite-stable colorectal cancer.
They expect these combinations might shrink tumours more often than denikitug alone; the main measure is objective response rate, meaning the proportion of participants whose tumours become smaller by standard scans. The study also measures safety, but it is not designed here to show that patients live longer or go longer before the cancer grows.
Worth knowing: This is a phase 2 study using tumour shrinkage as its main outcome, and the record does not identify a standard-treatment control arm.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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).
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 14 sites. Listed in: Australia, South Korea, Spain, United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07527858, registered by Gilead Sciences on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.