OncoMatch/Clinical Trials/NCT07735624
RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS/pMMR Early Rectal Cancer
Is NCT07735624 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Botensilimab and Balstilimab for early rectal cancer.
Treatment: Botensilimab · Balstilimab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: Mismatch-repair proficient (pMMR / MSS)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-CTLA-4 therapy
Received prior anti-CTLA-4 or anti-PD-1/PD-L1 therapy and/or other experimental immunologic agents
Cannot have received: anti-PD-1 therapy
Received prior anti-CTLA-4 or anti-PD-1/PD-L1 therapy and/or other experimental immunologic agents
Cannot have received: anti-PD-L1 therapy
Received prior anti-CTLA-4 or anti-PD-1/PD-L1 therapy and/or other experimental immunologic agents
Cannot have received: experimental immunologic agent
Received prior anti-CTLA-4 or anti-PD-1/PD-L1 therapy and/or other experimental immunologic agents
Cannot have received: prior therapy for rectal cancer
Prior therapy for rectal cancer
Cannot have received: prior pelvic radiation therapy
Prior pelvic radiation therapy
Cannot have received: prior treatment for rectal cancer
Prior treatment for rectal cancer
Lab requirements
Blood counts
Neutrophils ≥ 1500/μL (Must be stable and off any growth factor within 4 weeks of first study treatment administration); Platelets ≥ 50× 10^3/μL; Hemoglobin ≥ 8.0 g/dL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration)
Kidney function
Creatinine clearance ≥ 30 mL/min as measured or calculated per local institutional standards
Liver function
Aspartate aminotransferase/alanine aminotransferase ≤ 1.5 × upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN (except patients with Gilbert syndrome who must have a total bilirubin level of ≤ 3.0 × ULN)
Adequate organ function defined as the following laboratory values within 7 days of Cycle 1 Day 1 (C1D1): Neutrophils ≥ 1500/μL ... Platelets ≥ 50× 10^3/μL ... Hemoglobin ≥ 8.0 g/dL ... Creatinine clearance ≥ 30 mL/min ... AST/ALT ≤ 1.5 × ULN ... Total bilirubin ≤ 1.5 × ULN (except patients with Gilbert syndrome who must have a total bilirubin level of ≤ 3.0 × ULN)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
- Beth Israel Deaconess Medical Center (BIDMC) · Boston, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07735624 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require MLH1?
Yes, MLH1 wild-type is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 wild-type is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages