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NCT07750158PHASE3Recruiting

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

Exelixis

Start Date

8/25/2026

Completion Date

4/5/2030

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * Histologically confirmed diagnosis of Stage II or III adenocarcinoma of colon or rectum. * Documented local MSI and/or mismatch repair (MMR) test result demonstrating MSS, MSI-low, or pMMR status. * Colon or rectal cancer with completed definitive therapy. * ctDNA-positive based on local testing using the Natera Signatera tissue-informed molecular residual disease (MRD) assay. * No radiographic evidence of disease, as confirmed by a negative baseline computed tomography (CT) of the chest, abdomen, and pelvis (CAP), or CT of chest and magnetic resonance imaging (MRI) of abdomen/pelvis. Key Exclusion Criteria: * History of solid organ or allogeneic stem cell transplant. * Known additional malignancy that is progressing or has required active treatment within the past 2 years. * Prior treatment with immune checkpoint inhibitors (ICIs) or Vascular endothelial growth factor receptor (VEGFR) inhibitors. * History of CRC requiring systemic anticancer therapy prior to the definitive therapy. * Use of systemic anticancer therapy (including investigational therapy) or radiation therapy after the completion of definitive therapy. * Administration of a live, attenuated vaccine within 30 days of randomization and during treatment. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

Zanzalintinib

BIOLOGICAL

Pembrolizumab (+) Berahyaluronidase alfa

DRUG

Placebo

Interested in This Trial?

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Conditions

Colorectal Cancer

Locations

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

Council Bluffs, Iowa 51503

United States

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

Grand Island, Nebraska 68803

United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional

Grand Island, Nebraska 68803

United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Methodist

Omaha, Nebraska 68114

United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan

Omaha, Nebraska 68124

United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy

Omaha, Nebraska 68130

United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Papillion

Papillion, Nebraska 68046

United States

Astera Cancer Care

Bridgewater, New Jersey 08807

United States

Astera Cancer Care

East Brunswick, New Jersey 08816

United States

Astera Cancer Care

Edison, New Jersey 08820

United States

Astera Cancer Care

Monroe, New Jersey 08831

United States

Astera Cancer Care

Somerset, New Jersey 08873

United States

Astera Cancer Care

Toms River, New Jersey 08757

United States