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Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease
Sponsor: Exelixis
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
2026-08-25
Completion Date
2030-04-05
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
Zanzalintinib
Oral tablets administered once daily.
Pembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab + berahyaluronidase alfa fixed-dose combination administered via subcutaneous (SC) injection once every 3 weeks (Q3W).
Placebo
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