RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS/pMMR Early Rectal Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the 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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony rozpoznaniem histologiczne raka odbytnicy na wczesnym etapie (T1-T2 N0)
- •Wiek 18 lat lub więcej
- •Tumor musi być typu MSS/MMRp potwierdzone badaniami
- •Możliwość oceny guza endoskopią
- •Dobra funkcja nerek, wątroby i układu krwiotwórczego (wyniki badań laboratoryjnych w normie)
- •Zatwierdzenie przez zespół specjalistów (chirurg, onkolog, radiotolog) jako kandydat do zaplanowanej operacji
- •Dobry stan ogólny zdrowia (ECOG 0-1)
- •Dobrowolna zgoda na uczestnictwo w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 18, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (3)
Brigham and Women's Hospital
Boston, United States
Dana-Farber Cancer Institute
Boston, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, United States
Trial contact
Benjamin Schlechter, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/19/2026.
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