Actively Recruiting
A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-06
284
Participants Needed
7
Research Sites
260 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
A
Agenus Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The researchers are doing this study to find out whether the combination of botensilimab and balstilimab (BOT/BAL), followed by balstilimab alone, is an effective treatment for people with microsatellite stable (MSS) colorectal cancer or colorectal liver metastases (CRLM) who have measurable residual disease (MRD) after standard treatment with surgery and chemotherapy or total neoadjuvant therapy (TNT).
CONDITIONS
Official Title
A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject or legally authorized representative is willing and able to provide written informed consent.
- Histologically- or cytologically-confirmed colorectal cancer.
- 18 years of age or older on day of signing informed consent.
- Consent for use of archival tissue and blood draws for research purposes.
- Performance status of ECOG 0 or 1.
- Known non-MSI-H/pMMR status by IHC, PCR or NGS testing.
- Consent to undergo MSK IMPACT or NGS, if not previously done.
- Cohorts 1a and 2a: Completed complete surgical resection (R0) for stage III colon or rectal cancer, followed by adjuvant chemotherapy with FOLFOX or CAPEOX or total neoadjuvant therapy.
- Cohorts 1b and 2b: Completed complete surgical resection (R0) for liver metastasis and standard peri-operative chemotherapy.
- Completed definitive treatment for primary tumor including R0 resection or total neoadjuvant therapy for rectal cancer with full response.
- Positive circulating tumor DNA following completion of appropriate standard of care therapy.
- Signed informed consent within 6 weeks of positive ctDNA result.
- Adequate organ function including neutrophil count ≥ 1,500/mm³, platelet count ≥ 75,000/mm³, hemoglobin ≥ 9.0 g/dL, creatinine clearance ≥ 60 mL/min, AST and ALT ≤ 2.5 × ULN, bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN.
- Use of effective contraception during study and for at least 5 months after last dose for subjects of childbearing potential.
You will not qualify if you...
- Presence of metastatic or recurrent disease.
- Known DNA polymerase epsilon (POLE) or DNA polymerase delta (POLD) activating mutation.
- R1 or R2 resection (microscopic or macroscopic residual tumor).
- Currently participating in or recently participated in another investigational study within 4 weeks prior to first dose.
- Diagnosis of immunodeficiency or use of systemic immunosuppressive therapy within 7 days before first dose.
- Hypersensitivity to botensilimab, balstilimab, or their excipients.
- Chemotherapy, targeted therapy, or radiation within 2 weeks prior to study start or not recovered from previous treatment adverse events.
- History or evidence of active, non-infectious pneumonitis.
- Active infection requiring systemic therapy.
- Conditions or therapies that might interfere with trial results or participation.
- Psychiatric or substance abuse disorders interfering with trial cooperation.
- Pregnant, breastfeeding, or expecting to conceive or father children during the trial period.
- Prior therapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 agents.
- Active autoimmune disease or history requiring systemic treatment within 2 years, except some specified exceptions.
- Known active tuberculosis.
- Uncontrolled HIV infection.
- Known positive for active hepatitis B or C infections.
- Received a live vaccine within 30 days of study therapy start.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
N
Neil Segal, MD, PhD
CONTACT
L
Luis Diaz, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here