Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer
Sponsor: Solstice Oncology, Inc.
ClinicalTrials ID:NCT07808151
This trial evaluates the efficacy and safety of neoadjuvant pembrolizumab and porustobart in treating resectable pMMR/MSS colon cancer. Participants, aged 18+, with specific cancer criteria, receive pembrolizumab and either one or two doses of porustobart before surgery. Eligibility includes adequate organ function and ECOG 0-1. Follow-up occurs every 6 months for up to 3 years post-surgery.
Patient Parameters
| Parameter | Options |
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Program Overview
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
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Investigator Site | 90033 | Los Angeles | California |
| Investigator Site | 33612 | Tampa | Florida |
| Investigator Site | 60637 | Chicago | Illinois |
| Investigator Site | 21287 | Baltimore | Maryland |
| Investigator Site | 02114 | Boston | Massachusetts |
| Investigator Site | 10016 | New York | New York |
| Investigator Site | 10021 | New York | New York |
| Investigator Site | 10027 | New York | New York |
| Investigator Site | 44106 | Cleveland | Ohio |
| Investigator Site | 37232 | Nashville | Tennessee |
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