Zanzalintinib alone or with Pembrolizumab and Berahyaluronidase Alfa in colorectal cancer with molecular residual disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional study compares zanzalintinib alone and a combination of zanzalintinib with pembrolizumab and berahyaluronidase alfa against placebo in patients with colorectal cancer and molecular residual disease. Eligibility requires stage II/III adenocarcinoma of the colon or rectum, MSS/MSI-low/pMMR status, prior definitive therapy, ctDNA positivity by Signatera, and no radiographic disease. Exclusion criteria include prior immune checkpoint or VEGF receptor inhibitors and recent other malignancies requiring treatment. The trial is sponsored by Exelixis with Merck Sharp & Dohme as a collaborator and is conducted at selected Nebraska-based oncology clinics.

Why it matters

Who can join: the full rules

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.

Where it's running

• Oncology Hematology West, PC dba Nebraska Cancer Specialists - Council Bluffs
  Council Bluffs, Iowa, United States Recruiting
• Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
  Grand Island, Nebraska, United States Recruiting
• Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional
  Grand Island, Nebraska, United States Recruiting
• Oncology Hematology West, PC dba Nebraska Cancer Specialists - Methodist
  Omaha, Nebraska, United States Recruiting
• Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan
  Omaha, Nebraska, United States Recruiting
• Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy
  Omaha, Nebraska, United States Recruiting

Study contacts

• Study coordinator: Exelixis Clinical Trials
• Email: druginfo@exelixis.com
• Phone: 1-888-393-5494

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.