BATTMAN: A study evaluating if new immunotherapy drug treatment is better or worse than best supportive care available for people with unresectable bowel cancerBotensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma: The BATTMAN Trial

Exclusion

• 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.
• Refractory ascites defined as requiring 2 or more therapeutic paracenteses within the last 4 weeks or ≥ 4 times within the last 3 months or ≥ 1 time within the last 2 weeks or requiring diuretics within 2 weeks prior to study enrolment.
• Active or ongoing diarrhea of CTCAE grade 2 or higher.
• Tumour is mismatch repair deficient (dMMR) or microsatellite instability- high (MSI-H) per a standard local testing method.
• Prior exposure to anti-PD-1/PD-L1/CTLA-4 therapy.