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.
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).
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.
Parallel
Best Supportive Care
Other interventionMeasures designed to provide palliation of symptoms and improve quality of life as much as possible
Balstilimab
Drug450mg IV every 3 weeks
Botensilimab
Drug75mg IV every 6 weeks x 4 doses
Overall Survival
Progression Free Survival (PFS) based on RECIST 1.1 criteria
Overall Response Rate (ORR) based on RECIST 1.1 criteria
Clinical Benefit Rate (CBR) at 6 months based on RECIST 1.1 criteria
Health Related Quality of Life (HRQoL) utilizing EORTC QLQ-C30
30 items measuring: 5 functional domains (physical, role, cognitive, emotional and social functioning); 3 symptom domains (fatigue, pain, and nausea/vomiting); a global health status/QoL domain; and 6 single-item measures that assesses other symptoms such as dyspnea and insomnia.
Click on the lead sponsor to view all of their trials.
Canadian Cancer Trials Group
Lead sponsor
Agenus Inc.
Collaborator
Australasian Gastro-Intestinal Trials Group
Collaborator
UNICANCER
Collaborator
