Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer
A phase 2 trial of neoadjuvant porustobart (an anti-CTLA-4 antibody) plus pembrolizumab (an anti-PD-1 antibody) given before surgery in patients with resectable pMMR/MSS colon cancer.
NCT07808151 · Phase 2 · Solstice Oncology, Inc.
Recruiting sites: California, Florida, Illinois, Maryland, Massachusetts, New York, Ohio, Tennessee, Washington
Read 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