Actively Recruiting
Botensilimab, Balstilimab, and SBRT in Colorectal Cancer
Led by Massachusetts General Hospital · Updated on 2026-05-13
15
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
A
Agenus Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm pilot feasibility study evaluating the combination of Botensilimab and Balstilimab with Radiation Therapy (RT) in Non-Microsatellite Instability High (MSI-H) or Proficient Mismatch Repair (pMMR) chemorefractory colorectal cancer (CRC) with liver metastasis.
CONDITIONS
Official Title
Botensilimab, Balstilimab, and SBRT in Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed colorectal adenocarcinoma
- MSS or pMMR status confirmed by IHC or PCR
- At least 1 measurable (≥ 1 cm) previously unirradiated liver lesion suitable for ablative radiation
- Up to 5 liver lesions allowed if all can be treated with ablative radiation
- At least 1 measurable extrahepatic lesion outside radiation field
- Prior treatment with or intolerance to 5-FU, Oxaliplatin, and Irinotecan
- Age 18 years or older
- ECOG performance status 0 or 1
- Life expectancy greater than 3 months
- Adequate organ and marrow function including specified blood counts and liver/kidney tests
- Women of childbearing potential and men with such partners must agree to use effective contraception
- Negative pregnancy test for women of childbearing potential
- Ability to understand and sign informed consent
You will not qualify if you...
- Chemotherapy, targeted therapy, or study treatment within 14 days prior to starting study treatment unless recovered from related side effects
- Known or suspected active autoimmune disease
- Need for systemic corticosteroids (>10 mg prednisone daily) or immunosuppressives within 14 days prior to study drug
- Positive tuberculosis screening by IGRA test
- Recent or current bowel obstruction or refractory ascites
- Active or chronic hepatitis B or C infection
- Positive HIV or AIDS unless CD4 >200 cells/mm3 and/or undetectable viral load
- Uncontrolled illness or infection
- Psychiatric or substance abuse disorder interfering with study compliance
- Pregnancy, breastfeeding, or planning pregnancy during study period
- History or evidence of active non-infectious pneumonitis
- Active infection requiring systemic therapy
- Live vaccine within 30 days before study treatment
- Allergic reactions to similar compounds or severe hypersensitivity to monoclonal antibodies
- Uncontrolled brain metastases
- Significant active diarrhea
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
A
Aparna R. Parikh, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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