OncoMatch/Clinical Trials/NCT07152821
Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma
Is NCT07152821 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Balstilimab and Botensilimab for colorectal cancer.
Treatment: Balstilimab · Botensilimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Excluded: MMR deficient
not deficient mismatch repair (dMMR)
Excluded: MMR deficient
Tumour is mismatch repair deficient (dMMR)...per a standard local testing method
Excluded: MSI microsatellite instability-high
not...microsatellite instability-high (MSI-H)
Excluded: MSI microsatellite instability-high
Tumour is...microsatellite instability-high (MSI-H) per a standard local testing method
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: all available therapies
Received and failed all prior available therapies, such that the standard of care for the patient would be best supportive care (BSC)
Cannot have received: anti-PD-1 therapy
Prior exposure to anti-PD-1/PD-L1/CTLA-4 therapy
Cannot have received: anti-PD-L1 therapy
Prior exposure to anti-PD-1/PD-L1/CTLA-4 therapy
Cannot have received: anti-CTLA-4 therapy
Prior exposure to anti-PD-1/PD-L1/CTLA-4 therapy
Cannot have received: chemotherapy or biologic therapy
Exception: 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 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
Cannot have received: radiotherapy
Exception: within four weeks of first planned dose of study drug
Receipt of radiotherapy or investigational agents within four weeks of first planned dose of study drug
Cannot have received: investigational agents
Exception: within four weeks of first planned dose of study drug
Receipt of radiotherapy or investigational agents within four weeks of first planned dose of study drug
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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