Ireland
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Recruiting Phase 3

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

NCT07750158 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Phase 3
Started
2026-08-25
Last updated
2026-09-21

Condition(s) studied

Colorectal Cancer

Investigational drug(s) / intervention(s)

Zanzalintinib →Pembrolizumab (+) Berahyaluronidase alfaAll Pembrolizumab trials (624) →All ) Berahyaluronidase alfa trials (7) →Placebo

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Disease-Free Survival (DFS) in Zanzalintinib + MK-3475A Versus Placebo as Assessed by the Investigator — Up to 24 months
  • DFS in Zanzalintinib Monotherapy Versus Placebo as Assessed by the Investigator — Up to 24 months

Trial sites (13)

FacilityCityRegionStatus
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Council Bluffs Council Bluffs Iowa Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island Grand Island Nebraska Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional Grand Island Nebraska Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Methodist Omaha Nebraska Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan Omaha Nebraska Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy Omaha Nebraska Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Papillion Papillion Nebraska Recruiting
Astera Cancer Care Bridgewater New Jersey Recruiting
Astera Cancer Care East Brunswick New Jersey Recruiting
Astera Cancer Care Edison New Jersey Recruiting
Astera Cancer Care Monroe New Jersey Recruiting
Astera Cancer Care Somerset New Jersey Recruiting
Astera Cancer Care Toms River New Jersey Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07750158 on ClinicalTrials.gov ↗ ← All trials in the USA