Recruiting nowPhase 2Randomised
What this trial is trying to do
The researchers expect that combining pembrolizumab with porustobart, two medicines intended to help the immune system attack cancer, may destroy more of a microsatellite-stable (MSS) colon tumour before it is removed. The trial is testing whether one or two doses of porustobart with pembrolizumab produce a major pathological response, meaning little or no remaining cancer is seen in the surgical specimen, and whether the schedules are safe.
Giving treatment before surgery could make the tumour smaller or leave fewer cancer cells for surgery to remove, but this trial is measuring tumour response in the specimen and side effects rather than proving longer survival. The two treatment schedules are compared to see whether two porustobart doses improve the pre-surgery response or safety compared with one dose.
Worth knowing: This is a small, phase 2 comparison of two dosing schedules, and major pathological response is not the same as showing that people live longer or that the cancer will not return.
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 | NCT07808151 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 100 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Solstice Oncology, Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Pembrolizumab
- Drug Porustobart
What it is measuring
Major Pathologic Response (MPR) rate by Blinded Independent Pathologic Review (BIPR)
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 goal of this clinical trial is to learn if giving two medicines together, porustobart and pembrolizumab, before surgery can treat a common type of colon cancer called microsatellite stable (MSS) colon cancer in adults. This type of cancer can be removed with surgery and has not spread to other parts of the body. Both medicines work by helping the immune system fight cancer.
The main questions this study wants to answer:
How well do the medicines destroy the cancer before surgery? What side effects do participants have when taking the medicines?
Researchers will compare two groups to see which treatment schedule works better and is safer. Both groups get pembrolizumab. One group gets one dose of porustobart (Day 1 only), and the other group gets two doses (Day 1 and Day 22).
Participants will:
Complete certain tests and procedures to make sure they are eligible Get the medicines through a vein on Day 1 and Day 22 then have surgery 6-9 weeks after starting treatment Return for checkups and tests every 6 months for up to 3 years after surgery
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Colon
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
≥18 years of age at consent
Adenocarcinoma of the colon (rectosigmoid considered non-rectal); pMMR/MSS status
Any T3 or T4, N any, M0; disease amenable to surgical resection
ECOG Performance Status 0-1
Adequate tumor tissue sample with associated pathology report
Adequate hematologic, hepatic, and renal function
Reproductive status/contraception requirements per protocol
Exclusion Criteria
Investigational agent within 3 weeks of first dose
Imminent or urgent need for surgery
Prior treatment with ICIs targeting CTLA-4, PD-1, or PD-L1
Systemic corticosteroid/immunosuppressive therapy within 1 week of first dose (exceptions apply)
History of severe hypersensitivity to a fully human mAb; interstitial lung disease; pneumonitis requiring corticosteroids
Active or history of autoimmune disease requiring systemic treatment within 2 years
Major surgery within 4 weeks of first dose; active infection requiring treatment
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 30 sites. Listed in: Belgium, Italy, Netherlands, Spain, United Kingdom, 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 NCT07808151, registered by Solstice Oncology, Inc. 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.