NCT07808151RecruitingPhase 2
Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 3 Sept 2026
- Start date
- 30 Sept 2026
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- Solstice Oncology, Inc.
- Diseases
- Colorectal cancer
- NCT number
- NCT07808151
- EU CT number
- 2026-527233-58-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 30 Sept 2026 to the primary completion date, 30 Sept 2029
- 28 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Who the study is looking for
- ≥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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigator Site Coordinator of this site? Confirm its status | Anderlecht | Belgium | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Bonheiden | Belgium | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Ghent | Belgium | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Leuven | Belgium | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Liège | Belgium | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Ostend | Belgium | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Woluwe-Saint-Lambert | Belgium | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Aberdeen | United Kingdom | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Leeds | United Kingdom | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Pisa | Italy | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Baltimore | United States | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Boston | United States | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Chicago | United States | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Nashville | United States | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Investigator Site Coordinator of this site? Confirm its status | Tampa | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.