RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS/pMMR Early Rectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Tumor is MSI-H/MMRd per any local testing.
Known TMB >20mut/Mb or indication for immune checkpoint inhibitor therapy including hypermutated cancers.
Received prior anti-CTLA-4 or anti-PD-1/PD-L1 therapy and/or other experimental immunologic agents.
Partial or complete bowel obstruction within the last 3 months, signs/symptoms of bowel obstruction, or known radiologic evidence of impending obstruction.
Trial design
Treatments tested in this trial
- Botensilimab
- Balstilimab
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Dana-Farber Cancer Institute
Lead sponsor
Agenus Inc.
Collaborator
Gateway for Cancer Research
Collaborator
Source ClinicalTrials.gov