Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma
BATTMAN
1 other identifier
interventional
834
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 colorectal-cancer
Started Mar 2026
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2025
CompletedFirst Posted
Study publicly available on registry
September 3, 2025
CompletedStudy Start
First participant enrolled
March 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
April 22, 2026
April 1, 2026
2.8 years
August 26, 2025
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
34 months
Secondary Outcomes (8)
Progression Free Survival (PFS) based on RECIST 1.1 criteria
34 months
Overall Response Rate (ORR) based on RECIST 1.1 criteria
34 months
Clinical Benefit Rate (CBR) at 6 months based on RECIST 1.1 criteria
34 months
Health Related Quality of Life (HRQoL) utilizing EORTC QLQ-C30
34 months
Health Related Quality of Life (HRQoL) utilizing EORTC QLQ-CR29
34 months
- +3 more secondary outcomes
Study Arms (2)
Best Supportive Care
ACTIVE COMPARATORBotensilimab + Balstilimab and Best Supportive Care
EXPERIMENTALInterventions
Measures designed to provide palliation of symptoms and improve quality of life as much as possible
Eligibility Criteria
You may qualify if:
- Must have histologically confirmed colorectal adenocarcinoma that is not deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H).
- Received and failed all prior available therapies, such that the standard of care for the patient would be best supportive care (BSC).
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status 0, or 1.
- Must have presence of measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
- A life expectancy of ≥ 12 weeks at the time of study entry.
- Must be ≥ 18 years of age.
- Participants must consent to provision of, and investigator must agree to submit, a representative archival formalin fixed paraffin block of tumour tissue for correlative analyses when tumour tissue is available.
- Participants must have adequate organ and marrow function measured within 14 days prior to randomization.
- Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and health utility questionnaires in either English or French.
- Participant consent must be appropriately obtained in accordance with applicable local and national regulatory requirements.
- Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
- In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrolment.
- Participants of childbearing potential or partners of participants of childbearing potential must have agreed to use a highly effective contraceptive method
You may not qualify if:
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may be eligible for this trial, however, consultation with CCTG in advance of enrolment is required.
- A history of primary immunodeficiency, solid organ transplant or allogeneic bone marrow transplant.
- Current or prior use of immunosuppressive medication within 7 days before the first dose of study drugs, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease that has required systemic treatment within 2 years of the start of study drug.
- Active or uncontrolled intercurrent illness.
- Active brain metastases or leptomeningeal metastases.
- Receipt of live attenuated vaccination administered within 30 days prior to randomization.
- Lactating women who choose to breast feed.
- Any active disease condition which would render the protocol treatment dangerous or impair the ability of the participant to receive protocol therapy.
- Any condition that does not permit compliance with the protocol.
- Receipt of anti-cancer chemotherapy or biologic therapy within the lesser of i) 21 days, or ii) the usual cycle length of the regimen prior to the first planned dose of study drug.
- Receipt of radiotherapy or investigational agents within four weeks of first planned dose of study drug.
- Any unresolved toxicity (≥ CTCAE grade 2) from previous anti-cancer therapy.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- History of partial or complete bowel obstruction within the last 3 months prior to study enrolment, signs/symptoms of bowel obstruction or known radiologic evidence of impending obstruction.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Canadian Cancer Trials Grouplead
- Agenus Inc.collaborator
- Australasian Gastro-Intestinal Trials Groupcollaborator
- UNICANCERcollaborator
Study Sites (17)
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
BCCA - Prince George
Prince George, British Columbia, V2M 7E9, Canada
BCCA - Vancouver
Vancouver, British Columbia, V5Z 4E6, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
Waterloo Regional Health Network (WRHN)
Kitchener, Ontario, N2G 1G3, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6, Canada
Niagara Health System
St. Catharines, Ontario, L2S 0A9, Canada
North York General Hospital
Toronto, Ontario, M2K 1E1, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Sinai Health System
Toronto, Ontario, M5G 1X5, Canada
University Health Network
Toronto, Ontario, M5G 2M9, Canada
Centre Integre de Sante et de Services Sociaux
Greenfield Park, Quebec, J4V 2H1, Canada
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jonathan Loree
BCCA-Vancouver Cancer Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2025
First Posted
September 3, 2025
Study Start
March 31, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
June 30, 2029
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share