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NOT YET RECRUITING
NCT07750158
PHASE3

Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease

Sponsor: Exelixis

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the effectiveness of zanzalintinib + Pembrolizumab (+) berahyaluronidase alfa and zanzalintinib alone compared with placebo.

Official title: Randomized Phase 3 Study of Zanzalintinib ± Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Placebo in Participants With Colorectal Cancer With Stage II/III Molecular Residual Disease Following Definitive Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2026-08-06

Completion Date

2030-04-05

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

DRUG

Zanzalintinib

Oral tablets administered once daily.

BIOLOGICAL

Pembrolizumab (+) Berahyaluronidase alfa

Pembrolizumab + berahyaluronidase alfa fixed-dose combination administered via subcutaneous (SC) injection once every 3 weeks (Q3W).

DRUG

Placebo

Placebo to match zanzalintinib oral tablets administered once daily.