Zanzalintinib and Pembrolizumab for Colorectal Cancer
Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
600 (estimated)
Sponsor
Exelixis · Industry
Who this trial is looking for
This trial is looking for people with colorectal cancer who have completed their initial treatment and show signs of disease. Participants will receive either zanzalintinib alone or in combination with other drugs compared to a placebo.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Stage II or III colorectal cancer.
I have completed my initial cancer treatment.
I have a positive result for measurable residual disease.
I do not have any signs of cancer based on my imaging tests.
You may not be able to join if
I have had a solid organ or stem cell transplant.
I have another type of cancer that is active or has been treated in the last 2 years.
I have previously received treatment with immune checkpoint inhibitors.
I have received systemic cancer therapy or radiation after my initial treatment.
I have received a live vaccine within 30 days before starting the trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The primary objective of this study is to evaluate the effectiveness of zanzalintinib + Pembrolizumab (+) berahyaluronidase alfa and zanzalintinib alone compared with placebo.
Trial Locations
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Eligibility Criteria
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…
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.
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