Phase I Study of BT-001 Injection Followed by Pembrolizumab for Adults with Localized pMMR Rectal Cancer

What this Trial Is About

Researchers are conducting a Phase I clinical trial to assess the safety and tolerability of combining a modified vaccinia virus called BT-001 with pembrolizumab, a systemic immunotherapy drug, in adults with localized rectal cancer that has proficient mismatch repair pMMR. This study focuses on patients suitable for potentially curative surgery who have not received prior neoadjuvant therapy. The trial aims to understand the adverse effects and potential clinical benefits of this combination treatment in rectal cancer patients. Participants will receive two doses of BT-001 administered directly into the tumor using an endoscopic or transrectal ultrasound-guided injection, followed by a single systemic dose of pembrolizumab. The treatment is given as a single group without placebo comparison. The study treatment period and follow-up will assess both short-term safety within 30 days and longer-term oncological outcomes up to five years after treatment. Throughout the trial, participants will undergo evaluations including clinical exams, laboratory tests to monitor blood counts and organ function, and assessments of quality of life. Researchers will closely track adverse events, serious side effects, and dose-limiting toxicities within 30 days post-treatment. Additionally, the study will measure clinical responses within six weeks of starting treatment and monitor long-term outcomes and quality of life up to five years. Participation involves consenting to study procedures and attending scheduled visits for treatment and follow-up assessments.

Oncolytic Virotherapy to Enhance PReoperative IMmunotherapy Efficacy in Patients With Proficient Mismatch Repair (pMMR) Rectal Cancer