A Phase 2 Study of the Safety and Efficacy of Neoadjuvant Botensilimab in Combination With Balstilimab in the Treatment of Microsatellite Stable / Mismatch Repair Proficient Early Rectal Cancer (RECTIFY-1)
Dana-Farber Cancer Institute
Summary
This is a multi-site, prospective, non-randomized phase 2 study evaluating neoadjuvant botensilimab in combination with balstilimab for patients with microsatellite stable (MSS) / mismatch repair proficient (MMRp) early rectal cancer staged T1-T2 N0 by MRI and considered candidates for surgical resection without standard neoadjuvant therapies. Participants will receive a single IV dose of botensilimab on Day 1 followed by balstilimab IV every 2 weeks for up to 6 months, with tumor response assessments during treatment and follow-up afterward.
Description
This study is a multi-site, prospective, non-randomized, phase 2 trial. The protocol proposes to treat 16 participants with a single fixed dose of botensilimab 75 mg IV on the first day of treatment, followed by balstilimab 240 mg IV every 2 weeks for up to 6 months. The schema states that patients with stage I MSS/MMRp rectal cancer (T1-2 N0 by MRI) will undergo tumor response assessment during treatment for 6 months. After treatment, participants with complete or near complete response and pathologic complete response at local excision may undergo non-operative management with long-term surv…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed diagnosis of early-rectal cancer clinically staged T1-T2 N0 M0 by MRI (American Joint Committee on Cancer (AJCC) staging 8th edition, 2017). * The tumor must confirmed to be MSS/MMRp by local testing. * The tumor must be evaluable by endoscopy. * Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures. * Age ≥ 18 years of age. Because no dosing or adverse event data are currently available on the use of botensilimab with balstilimab in participants \< 18 years of age, children…