Actively Recruiting
A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-05
40
Participants Needed
7
Research Sites
156 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 purpose of this study is to find out whether the combination of botensilimab and balstilimab (BOT/BAL) is a safe and effective treatment that causes few or mild side effects for people with mismatch repair proficient (MMRp)/microsatellite stable (MSS) locally advanced rectal adenocarcinoma. The investigators will also find out whether BOT/BAL is an effective treatment when given in combination with standard chemotherapy.
CONDITIONS
Official Title
A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent for trial or have a legally authorized representative provide consent
- 18 years of age or older at the time of signing informed consent
- ECOG performance status of 0 or 1
- Histologically confirmed rectal adenocarcinoma
- Adenocarcinoma with distal margin 15 cm or less from anal verge, staged as cT3/cT4 N0 or cT(any) cN1/2 by endorectal ultrasound or MRI
- No evidence of distant metastases
- Measurable or clinically evaluable disease
- Tumor specimen shows intact mismatch repair enzymes or microsatellite stability
- Negative pregnancy test within 14 days before treatment for women of childbearing potential
- Women of childbearing potential must use adequate contraception during the study and for 150 days after last dose
- Nonchildbearing potential defined by age, menstrual history, or surgical sterilization
- Adequate organ function as defined by blood counts, kidney and liver function tests, and coagulation parameters within 28 days before treatment
You will not qualify if you...
- Recurrent rectal cancer
- Prior pelvic radiation, chemotherapy, or surgery for rectal cancer
- Tumor causing symptomatic bowel obstruction (temporary diverting ostomy allowed)
- Other invasive malignancy within 2 years except treated non-melanoma skin cancer or in situ cervical carcinoma
- Active infection requiring systemic therapy
- Receiving other anticancer or experimental therapies during study treatment
- History of interstitial lung disease or pneumonitis
- Known HIV infection
- Known active hepatitis B or hepatitis C infection
- Live vaccination within 28 days before first immunotherapy dose
- SARS-CoV-2 vaccine or booster within 7 days before first treatment dose
- Significant cardiovascular disease within 180 days before enrollment or QTcF ≥450 ms
- Known active tuberculosis
- Systemic corticosteroid or immunosuppressive therapy within 1 week before first study drug dose (with some exceptions)
- History or evidence of significant autoimmune disease requiring systemic immunosuppression within 5 years
- Prior allogeneic tissue or solid organ transplant except corneal transplant
AI-Screening
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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 Cancer Center at Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited 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)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
A
Andrea Cercek, MD
CONTACT
P
Paul Romesser, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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