RecruitingPhase 3NCT07750158

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

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

Sponsor

Exelixis

Enrollment

600 participants

Start Date

Aug 25, 2026

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Pembrolizumab (+) Berahyaluronidase alfa, a drug called Placebo, and others for people with colorectal, cancer. The study is currently recruiting participants at 13 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZanzalintinib

Oral tablets administered once daily.

BIOLOGICALPembrolizumab (+) Berahyaluronidase alfa

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

DRUGPlacebo

Placebo to match zanzalintinib oral tablets administered once daily.

Locations(13)

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Council Bluffs

Council Bluffs, Iowa, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island

Grand Island, Nebraska, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional

Grand Island, Nebraska, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Methodist

Omaha, Nebraska, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan

Omaha, Nebraska, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy

Omaha, Nebraska, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Papillion

Papillion, Nebraska, United States

Astera Cancer Care

Bridgewater, New Jersey, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

Astera Cancer Care

Edison, New Jersey, United States

Astera Cancer Care

Monroe, New Jersey, United States

Astera Cancer Care

Somerset, New Jersey, United States

Astera Cancer Care

Toms River, New Jersey, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07750158

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