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Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma

This study is looking at a new treatment combination, botensilimab and balstilimab, for people with locally advanced rectal adenocarcinoma that is microsatellite stable (MSS) or mismatch repair proficient (MMRp). This means your cancer cells do not have certain genetic changes that some other treatments target. Researchers want to see if this combination is safe, causes few side effects, and is effective, both on its own and when given with standard chemotherapy. The main goal is to measure how many participants respond to the treatment within one year. About 40 people aged 18 or older can join this study, which is currently unclear if it's recruiting.

Study design
This is an interventional study planning to enroll 40 participants. It is testing two drugs, botensilimab and balstilimab, alone and in combination with standard chemotherapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the best overall response rate at 1 year after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06843434

A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~40 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:BalstilimabBotensilimab

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Best Overall Response Rate
Measured over 1 year

Conditions

Microsatellite Stable Rectal Carcinoma
Locally Advanced Rectal Adenocarcinoma

Explore related trials

Rectal AdenocarcinomaMRC1 wt AlleleMSI1 Gene

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Andrea Cercek, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Andrea Cercek, MD
[email protected]
646-888-4189
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Willing and able to provide written informed consent for trial.
Be ≥18 years of age on the date of signing informed consent.
ECOG performance status of 0 or 1.
Histologically confirmed rectal adenocarcinoma.
Adenocarcinoma with distal margin of 15 cm or less from the anal verge on endoscopy, staged with endorectal ultrasound (ERUS) or magnetic resonance imaging (MRI) as cT3/cT4 N0 or cT(any) cN1/2.
No evidence of distant metastases
Radiologically measurable or clinically evaluable disease per Protocol Section 13.0.
Tumor specimen that demonstrates intact mismatch repair enzymes by immunohistochemistry or microsatellite stability as demonstrated by NGS or PCR.
Negative pregnancy test done within 14 days prior to beginning treatment, for women of childbearing potential only. Subjects of childbearing potential must be willing to use an adequate method of contraception. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom). Contraception is required for the course of the study starting with the first dose of study medication through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Nonchildbearing potential is defined as follows (by other than medical reasons):
Demonstrate adequate organ function as defined in the Table 6-1 below within 28 days of Cycle 1 Day 1, and all screening labs should be performed within 28 days of treatment initiation.

Exclusion

Recurrent rectal cancer.
Prior pelvic radiation therapy, chemotherapy, or surgery for rectal cancer.
Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible).
Other invasive malignancy ≤ 2 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma.
Active infection requiring systemic therapy.
Other anticancer or experimental therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.
Known history of interstitial lung diseases/pneumonitis
Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
Known active hepatitis B (e.g., HbsAg reactive) or hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
Live vaccination within 28 days prior to receiving the first dose of immunotherapy. The use of inactivated seasonal influenza vaccines (e.g., Fluzone®) will be permitted on study without restriction.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine or booster \< 7 days before C1D1. For vaccines requiring more than 1 dose, the full series should be completed prior to C1D1, when feasible. Booster shot not required but also must be administered \> 7 days from C1D1 or \> 7 days from future cycle on study
Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 180 days of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.
Known active tuberculosis.
Receiving systemic corticosteroid therapy 1 week prior to the first dose of study drug or receiving any other form of systemic immunosuppressive medication.
Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments. The following are not exclusionary: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement.
Prior allogeneic tissue/solid organ transplant, except for corneal transplants.

What this trial measures

  • Best Overall Response Rate1 year

    The primary objective of this study is to determine the best overall response rate (ORR) after initial neoadjuvant combination botensilimab and balstilimab in subjects with MMRp/MSS locally advanced (stage II or III) rectal adenocarcinoma. ORR is defined by rectal MRI and endoscopic exam and graded as progressive disease (PD), stable disease (SD) (sustained for 3 months), partial response (PR), near complete response (nCR) and clinical complete response (cCR). Patients with PR, nCR, or cCR will be considered responders, while the rest will be non-responders.