Phase II Study of FOLFOX Combined with Botensilimab and Balstilimab Before Surgery for Localized Rectal Cancer

What this Trial Is About

Researchers are evaluating a combination of chemotherapy drugs and immunotherapy before surgery to treat patients with localized rectal adenocarcinoma that has not spread to other parts of the body. The study is a phase II trial aiming to improve the rate of complete clinical response and reduce the need for surgery and radiation therapy compared to current treatments. The trial is sponsored by City of Hope Medical Center and focuses on using FOLFOX chemotherapy with botensilimab and balstilimab. Participants receive a combination of leucovorin calcium, oxaliplatin, and fluorouracil intravenously in cycles every 14 days for up to 8 cycles. Botensilimab is given intravenously on day 1 of cycles 1 and 4, and balstilimab is given intravenously on day 1 of each cycle. Those who achieve a complete clinical response may continue balstilimab alone for up to 12 additional cycles. If a complete response is not achieved, patients may receive radiation therapy daily on weekdays alongside oral capecitabine as part of standard care. Throughout the study, participants undergo various procedures including blood sampling, biopsies with endoscopic exams, sigmoidoscopy, digital rectal exams, CT scans, and MRI. Participants are followed closely with visits at 30 and 90 days after treatment, then every 3 months for the first year, and every 6 months for up to 2 years. The study measures the complete clinical response rate at 3 months post-treatment as the primary outcome. Secondary measures include overall response rate, disease-free survival, progression-free survival, pelvic recurrence, duration of response, and overall survival up to 5 years. Safety is also monitored through adverse event tracking. The trial collects blood biomarkers and examines tumor changes to explore treatment impact further.

FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery