Phase II Study of Botensilimab and Balstilimab Immunotherapy Combined with Chemotherapy for Locally Advanced Mismatch Repair Proficient Rectal Adenocarcinoma

What this Trial Is About

Researchers are evaluating the combination of botensilimab and balstilimab BOTBAL as a potential treatment for people with mismatch repair proficient MMRp or microsatellite stable MSS locally advanced rectal adenocarcinoma. The study aims to determine if this combination is safe, causes few or mild side effects, and is effective when given alongside standard chemotherapy. This is a Phase II study focused on neoadjuvant immunotherapy for rectal cancer. Participants will receive the study drugs botensilimab and balstilimab. Botensilimab is an engineered antibody designed to enhance immune responses against cancer cells, while balstilimab blocks specific proteins that help tumors evade the immune system. The treatment is given before surgery to shrink tumors, and up to 40 patients with stage II or III rectal cancer and mismatch repair proficiency will be enrolled. During the study, participants will be closely monitored with medical evaluations and laboratory tests to assess tumor response and safety. The primary outcome is the best overall response rate measured one year after treatment starts. Participants must meet specific health and diagnostic criteria, and their organ function will be checked before treatment. The total participation lasts until the primary outcome assessment, with ongoing safety evaluations by the research team.

A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma