NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07750158

Not Yet RecruitingPhase 3

Sponsor: Exelixis

Conditions: Colorectal Cancer

Interventions: Zanzalintinib, MK-34574, Placebo

The primary objective of this study is to evaluate the effectiveness of zanzalintinib + MK-3475A and zanzalintinib alone compared with placebo.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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.