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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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
What is being tested
- Pembrolizumab (drug)
- Porustobart (drug)
Sponsor: Solstice Oncology, Inc. · Participants: 100 · Started: Nov 30, 2026
Contact the study team
- Medical Monitor · Phone: 617-982-2331
Official record on ClinicalTrials.gov — NCT07808151
Locations in the U.S.
| California | Investigator Site, Los Angeles |
| Florida | Investigator Site, Tampa (Not yet recruiting) |
| Illinois | Investigator Site, Chicago (Not yet recruiting) |
| Maryland | Investigator Site, Baltimore |
| Massachusetts | Investigator Site, Boston (Not yet recruiting) |
| New York | Investigator Site, New York (Not yet recruiting) Investigator Site, New York (Not yet recruiting) Investigator Site, New York (Not yet recruiting) |
| Ohio | Investigator Site, Cleveland |
| Tennessee | Investigator Site, Nashville (Not yet recruiting) |
| Washington | Investigator Site, Seattle |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.