Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing whether BMS-986488, alone or combined with nivolumab (an immune checkpoint inhibitor), adagrasib (a KRAS G12C-targeted drug) or cetuximab (an EGFR-targeted antibody), can be given safely and may show anti-cancer activity in advanced cancers. The trial is testing several treatment combinations rather than a particular treatment sequence.
The idea is that combining immune-based treatment with targeted drugs could produce more anti-cancer activity than a single experimental drug, but this trial mainly measures safety and tolerability, along with early signs of tumour control. There is no standard-treatment comparison, and the study does not measure whether patients live longer.
Worth knowing: This is a non-randomised phase 1 trial whose main outcome is adverse events, so it is designed chiefly to find a safe dose and schedule rather than establish benefit.
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.
| Registry number | NCT06764771 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | not randomised, open label |
| Taking part | 437 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Bristol-Myers Squibb |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug BMS-986488
- Drug Adagrasib
- Drug Cetuximab
- Drug Nivolumab
What it is measuring
Number of participants with Adverse Events (AEs)
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.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- (K/N)RAS mutated
- G12C
- Metastatic
- Locally advanced
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
Inclusion Criteria
- Participant must be ≥ 18 years of age.
- Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:.
- Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC).
- Parts 2A, 1D, 2D: ccRCC.
i) Part 1B: solid tumors with KRAS G12C mutation.
ii) Part 2B: NSCLC with KRAS G12C mutation.
iii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation.
- Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1.
- Participants must have measurable disease per RECIST v1.1.
Exclusion Criteria
- Untreated central nervous system (CNS) metastases.
- Leptomeningeal metastasis (carcinomatous meningitis).
- Impaired cardiac function or clinically significant cardiac disease.
- For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):.
i) History of pneumonitis or interstitial lung disease (ILD).
ii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
- Other protocol-defined inclusion/exclusion criteria apply.
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 8 sites. Listed in: Australia, Canada, 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?
- This trial recruits across several cancer types rather than being designed around bowel cancer. Is there evidence it does anything in mine?
The source
Registry record NCT06764771, registered by Bristol-Myers Squibb 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.