Recruiting nowPhase 2Randomised
What this trial is trying to do
The idea is that microscopic colorectal cancer left after surgery and chemotherapy can be detected through circulating tumour DNA (ctDNA), and that combining botensilimab, a CTLA-4 immune-checkpoint blocker, with balstilimab, a PD-1 blocker, may help the immune system remove it. The trial tests this combination followed by balstilimab alone in people whose ctDNA remains detectable after standard treatment.
The researchers are comparing the treatment with placebo to see whether more patients clear their ctDNA, which could indicate that measurable residual disease has been eliminated. The main improvement being measured is ctDNA clearance, rather than longer survival or a longer time before visible recurrence.
Worth knowing: ctDNA clearance is an indirect measure, so this trial does not yet show whether the treatment helps people live longer or prevents recurrence.
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 | NCT07227636 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, blinded |
| Taking part | 284 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Memorial Sloan Kettering Cancer Center |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Botensilimab
- Drug Balstilimab
- Other Placebo
What it is measuring
Rate of ctDNA clearance (Cohort 1a)
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 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 researchers are doing this study to find out whether the combination of botensilimab and balstilimab (BOT/BAL), followed by balstilimab alone, is an effective treatment for people with microsatellite stable (MSS) colorectal cancer or colorectal liver metastases (CRLM) who have measurable residual disease (MRD) after standard treatment with surgery and chemotherapy or total neoadjuvant therapy (TNT).
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Rectal
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
- Subject or legally authorized representative, is willing and able to provide written informed consent.
- Histologically- or cytologically- confirmed colorectal cancer.
- ≥ 18 years of age on day of signing informed consent.
- Consent for use of archival tissue and blood draws for research purposes.
- Performance status of ECOG 0 or 1.
- Known non-MSI-H/pMMR by IHC, PCR or NGS testing. MSKCC confirmation of non-MSI-H/pMMR status is not mandatory prior to enrollment and treatment on the study. For patients with outside testing, if sufficient tissue is available testing may be repeated at MSKCC and will not impact initial eligibility.
- Consent to undergo MSK IMPACT or NGS, if not previously done
- Disease specific criteria:
1. Cohorts 1a and 2a: Undergone a complete surgical resection (R0) for stage III colon or rectal cancer, followed by adjuvant chemotherapy with FOLFOX or CAPEOX. Post-operative chemotherapy not required if received previous oxaliplatin-based therapy. Total Neoadjuvant Therapy for rectal cancer with complete clinical and radiographic response is allowed.
2. Cohorts 1b and 2b: Undergone a complete surgical resection (R0) for liver metastasis (ablation or stereotactic body radiation therapy [SBRT], but not Y-90, is permitted) and completed standard peri-operative chemotherapy.
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 7 sites. Listed in: 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 NCT07227636, registered by Memorial Sloan Kettering Cancer Center 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.