Actively Recruiting
A Phase II Study of Neoadjuvant Botensilimab and Balstilimab Immunotherapy for Mismatch Repair Proficient Rectal Adenocarcinoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-05
40
Participants Needed
7
Research Sites
N/A
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
Researchers are studying the combination of botensilimab and balstilimab (BOT/BAL) to see if it is a safe and effective treatment with few or mild side effects for people with mismatch repair proficient (MMRp) or microsatellite stable (MSS) locally advanced rectal adenocarcinoma. This phase II study also evaluates whether BOT/BAL works well when given together with standard chemotherapy. The study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on patients with stage II or III rectal cancer. Participants will receive the immunotherapy drugs botensilimab and balstilimab before surgery. Botensilimab is designed to enhance immune response by targeting CTLA-4, while balstilimab blocks PD-1 binding to its ligands. Up to 40 patients with measurable locally advanced rectal cancer will be treated. The treatment is given as neoadjuvant therapy, meaning before the main treatment, to assess its impact on the tumor. During the study, participants will be monitored closely with various tests to evaluate their health and tumor response. Researchers will measure the best overall response rate within one year to assess treatment effect. Safety and organ function will be checked regularly, and patients must meet specific health criteria to join. The study lasts through the treatment and follow-up periods, ensuring detailed data collection about the immunotherapy combination's impact on rectal adenocarcinoma.
CONDITIONS
Brief 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 to consent
- Be 18 years of age or older at consent
- ECOG performance status of 0 or 1
- Histologically confirmed rectal adenocarcinoma
- Tumor with distal margin 15 cm or less from anal verge, staged as cT3/cT4 N0 or cT(any) cN1/2
- No evidence of distant metastases
- Radiologically measurable or clinically evaluable disease
- Tumor specimen showing intact mismatch repair enzymes or microsatellite stability
- Negative pregnancy test within 14 days prior to treatment for women of childbearing potential
- Women of childbearing potential must use adequate contraception during study and for 150 days after last dose
- Nonchildbearing potential defined by age or surgical history as detailed
- Demonstrate adequate organ function within 28 days of treatment start
You will not qualify if you...
- Recurrent rectal cancer
- Prior pelvic radiation therapy, chemotherapy, or surgery for rectal cancer
- Tumor causing symptomatic bowel obstruction (except patients with temporary diverting ostomy)
- Other invasive malignancy within 2 years except certain skin and cervical cancers
- Active infection needing systemic therapy
- Use of other anticancer or experimental therapies during study treatment
- Known history of interstitial lung disease or pneumonitis
- Known HIV infection
- Active hepatitis B or C infection
- Live vaccination within 28 days prior to first immunotherapy dose
- SARS-CoV-2 vaccine or booster less than 7 days before treatment
- Significant cardiovascular disease within 180 days including stroke, heart attack, unstable angina, severe heart failure, or serious arrhythmia
- QTcF interval of 450 ms or more
- Known active tuberculosis
- Systemic corticosteroid therapy within 1 week before first dose or other systemic immunosuppressive medication (with exceptions)
- Recent or ongoing significant autoimmune disease requiring systemic immunosuppressive treatment
- Prior allogeneic tissue or solid organ transplant except corneal transplants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive neoadjuvant immunotherapy with Botensilimab and Balstilimab for rectal adenocarcinoma.
Visits scheduled according to treatment cycles as determined by the study team
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
P
Paul Romesser, MD
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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