Pembrolizumab and porustobart before surgery for colon cancer that can be removed
Tests pembrolizumab with porustobart before surgery in adults with colon cancer.
Plain-language title generated from the registry record
Registry title: Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer
Key facts
- Where
- Barcelona, L'Hospitalet de Llobregat, and Madrid, SpainSee the 3 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with colon cancer that can be removed by surgery and has not spread. The tumour must be pMMR/MSS.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Adenocarcinoma of the colon, any T3 or T4, N any, M0, able to be removed by surgery. The rectosigmoid counts as colon.
- Earlier treatment
- No earlier treatment with immune drugs that target CTLA-4, PD-1 or PD-L1. No investigational drug within 3 weeks before the first dose.
- Biomarker or test result
- pMMR/MSS tumour status
Main reasons for not taking part
- Urgent need for surgery
- Earlier treatment with CTLA-4, PD-1 or PD-L1 immune drugs
- Autoimmune disease needing systemic treatment within 2 years
- Major surgery within 4 weeks of the first dose
- Active infection needing treatment
Read by machine on 9 November 2026.
Where in Spain
- BarcelonaBarcelona, SpainNot yet recruiting
- L'Hospitalet de LlobregatL'Hospitalet de Llobregat, SpainNot yet recruiting
- MadridMadrid, SpainNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Solstice Oncology, Inc.
- Trial code
- NCT07808151EU 2026-527233-58-00
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 2, Open-Label, Multicenter, Randomized Trial Evaluating the Efficacy and Safety of Different Schedules of Neoadjuvant Pembrolizumab and Porustobart in Patients With Resectable pMMR/MSS Colon Cancer
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
Inclusion: ≥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: 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.