Study on Zanzalintinib Alone or with Pembrolizumab and Berahyaluronidase Alfa for Colorectal Cancer with Molecular Residual Disease

Sponsor: Exelixis

Sponsor score: 40

ClinicalTrials ID:NCT07750158

This clinical trial is testing the effectiveness of the drug zanzalintinib, both alone and in combination with pembrolizumab and berahyaluronidase alfa, compared to a placebo in patients with colorectal cancer who have molecular residual disease.

Patient Parameters

Program Overview

The main goal of this study is to see how well the drug zanzalintinib works by itself or when combined with pembrolizumab and berahyaluronidase alfa, compared to a placebo, in treating patients with colorectal cancer who have molecular residual disease. This means the cancer has been treated but small amounts of cancer-related molecules are still detectable.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Stage II or III colon or rectal cancer.
  • Test results showing specific genetic markers (MSS, MSI-low, or pMMR).
  • Completed all main treatments for colon or rectal cancer.
  • Positive for circulating tumor DNA (ctDNA) using a specific test.
  • No visible signs of cancer on recent CT or MRI scans of the chest, abdomen, and pelvis.

Exclusion Criteria

  • History of organ or stem cell transplant.
  • Another cancer that is growing or needed treatment in the last 2 years.
  • Previous treatment with certain immune or cancer drugs.
  • Colorectal cancer that needed systemic treatment before main therapy.
  • Use of cancer treatments or radiation after main therapy.
  • Received a live vaccine within 30 days before starting the study or during treatment.

Locations

FACILITYZIPCITYSTATE
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Council Bluffs51503Council BluffsIowa
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island68803Grand IslandNebraska
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional68803Grand IslandNebraska
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Methodist68114OmahaNebraska
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan68124OmahaNebraska
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy68130OmahaNebraska
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Papillion68046PapillionNebraska
Astera Cancer Care08807BridgewaterNew Jersey
Astera Cancer Care08816East BrunswickNew Jersey
Astera Cancer Care08820EdisonNew Jersey

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