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Zanzalintinib ± MK-3475A in Colorectal Cancer with Molecular Residual Disease

NCT07750158Phase 3

Key facts

Status: Recruiting
Start: Aug 2026
Primary completion: Apr 2030
Countries: 1
Sponsor: Exelixis, Inc.

Drugs: zanzalintinib
Conditions: colorectal cancer (CRC)

Overview

Phase 3, randomised, double-blind trial of zanzalintinib in colorectal cancer (CRC) (3 arms), sponsored by Exelixis, Inc. Primary endpoint: Disease-Free Survival at 24 months. Started Aug 2026; status: recruiting.

Design

3 arms

Study design: RandomizedDouble-blind

Zanzalintinib + Pembrolizumab (+) Berahyaluronidase alfa
Zanzalintinib oral tablets once daily + Pembrolizumab/berahyaluronidase alfa SC Q3W for up to 2 years.
Zanzalintinib Monotherapy
Zanzalintinib oral tablets once daily for up to 2 years.
Placebo
Placebo to match zanzalintinib oral tablets once daily for up to 2 years.

Who it enrols

Patients with Stage II or III colorectal adenocarcinoma who have completed definitive therapy, have no radiographic evidence of disease, but are ctDNA-positive (molecular residual disease) and have MSS, MSI-low, or pMMR status. Excludes patients with prior ICI or VEGFR inhibitor treatment, or history of solid organ/allogeneic stem cell transplant.

Endpoints

Primary

Disease-Free Survival24 months

Secondary

Proportion of Participants with ctDNA Clearance24 months
Overall Survival24 months
Disease-Free Survival24 months
Treatment Emergent Adverse Events24 months

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