Actively Recruiting
Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma
Led by Canadian Cancer Trials Group · Updated on 2026-05-12
834
Participants Needed
20
Research Sites
169 weeks
Total Duration
On this page
Sponsors
C
Canadian Cancer Trials Group
Lead Sponsor
A
Agenus Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is being done to answer the main question of: Do patients with colorectal cancer that cannot be removed by surgery, that is treated with two new immunotherapy drugs, botensilimab and balstilimab, live longer? Other important questions include: Is their quality of life better? Do their tumours slow in growth or possibly shrink in size? Are there markers in their tumour or blood that can predict whether they achieve any of these benefits? In addition, the study is done to confirm the safety of these immunotherapy drugs and to determine how long it takes for the body to metabolize them.
CONDITIONS
Official Title
Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed colorectal adenocarcinoma that is not deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H)
- Failed all prior available therapies and standard care is best supportive care
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Presence of measurable or evaluable disease as defined by RECIST 1.1
- Life expectancy of at least 12 weeks at study entry
- 18 years of age or older
- Consent to provide archival tumor tissue when available
- Adequate organ and marrow function within 14 days before randomization
- Able and willing to complete quality of life and health questionnaires in English or French
- Consent obtained according to local and national regulations
- Accessible for treatment and follow-up
- Protocol treatment to begin within 2 working days of enrollment
- Participants of childbearing potential and their partners must use highly effective contraception
You will not qualify if you...
- Prior or concurrent malignancy that may interfere with study safety or efficacy assessment without prior consultation
- History of primary immunodeficiency, solid organ transplant, or allogeneic bone marrow transplant
- Use of immunosuppressive medication within 7 days before first study drug dose except certain corticosteroids
- Active or prior autoimmune or inflammatory disorders requiring systemic treatment within 2 years
- Active or uncontrolled illness
- Active brain or leptomeningeal metastases
- Live attenuated vaccine within 30 days before randomization
- Lactating women who choose to breastfeed
- Any condition making protocol treatment dangerous or impairing compliance
- Anti-cancer chemotherapy or biologic therapy within 21 days or usual cycle length before first study drug dose
- Radiotherapy or investigational agents within 4 weeks before first study drug dose
- Unresolved toxicity from prior anti-cancer therapy of grade 2 or higher
- Known allergy or hypersensitivity to study drugs or excipients
- Recent or impending bowel obstruction
- Refractory ascites requiring frequent drainage or diuretics
- Active diarrhea of grade 2 or higher
- Tumor mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H)
- Prior exposure to anti-PD-1, PD-L1, or CTLA-4 therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
2
BCCA - Prince George
Prince George, British Columbia, Canada, V2M 7E9
Actively Recruiting
3
BCCA - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
4
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
5
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
6
Waterloo Regional Health Network (WRHN)
Kitchener, Ontario, Canada, N2G 1G3
Actively Recruiting
7
Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Actively Recruiting
8
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
9
Niagara Health System
St. Catharines, Ontario, Canada, L2S 0A9
Actively Recruiting
10
North York General Hospital
Toronto, Ontario, Canada, M2K 1E1
Actively Recruiting
11
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
12
Sinai Health System
Toronto, Ontario, Canada, M5G 1X5
Actively Recruiting
13
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
14
Centre Integre de Sante et de Services Sociaux
Greenfield Park, Quebec, Canada, J4V 2H1
Actively Recruiting
15
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
16
The Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
17
Hotel-Dieu de Quebec
Québec, Quebec, Canada, G1R 2J6
Actively Recruiting
18
CIUSSS de l'Estrie - Centre hospitalier
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
19
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Actively Recruiting
20
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Actively Recruiting
Research Team
C
Chris O'Callaghan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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