RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS/pMMR Early Rectal Cancer

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.

Trial Details

NCT ID
NCT07735624
Phase
PHASE2
Sponsor
Dana-Farber Cancer Institute
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Botensilimab
  • Balstilimab
Locations (sample)
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Histologically confirmed diagnosis of early-rectal cancer clinically staged T1-T2 N0 M0 by MRI (American Joint Committee on Cancer (AJCC) staging 8…
  • 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.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Colorectal Cancer Trials on Trialify →