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

RecruitingPhase 3Ages 18 Years - anyAllExelixis
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • Zanzalintinib
  • Pembrolizumab (+) Berahyaluronidase alfa
  • Placebo
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Where

13 sites
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Council Bluffs
Council Bluffs, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
Grand Island, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional
Grand Island, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Methodist
Omaha, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan
Omaha, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy
Omaha, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Papillion
Papillion, United States
Astera Cancer Care
Bridgewater, United States

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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