[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650637":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":44,"centralContacts":48,"locations":43,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":43,"enrollmentInfo":69,"targetDuration":43,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":90,"whyStopped":43,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":96,"leadSponsor":98,"locationsCount":43},{"fullName":5,"class":6},"Exelixis","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Zanzalintinib + MK-3475A","EXPERIMENTAL","Participants will receive zanzalintinib in combination with MK-3475A (pembrolizumab + berahyaluronidase alfa) for up to 2 years.",[13,14],"Drug: Zanzalintinib","Biological: MK-34574",{"label":16,"type":10,"description":17,"interventionNames":18},"Zanzalintinib Monotherapy","Participants will receive zanzalintinib for up to 2 years.",[13],{"label":20,"type":10,"description":21,"interventionNames":22},"Placebo","Participants will receive placebo to match zanzalintinib for up to 2 years.",[23],"Drug: Placebo",[25,32,40],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Zanzalintinib","Oral tablets administered once daily.",[9,16],[31],"XL092",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"BIOLOGICAL","MK-34574","Pembrolizumab + berahyaluronidase alfa fixed-dose combination administered via subcutaneous (SC) injection once every 3 weeks (Q3W).",[9],[38,39],"KEYTRUDA QLEX™","KEYTRUDA SC",{"type":26,"name":20,"description":41,"armGroupLabels":42,"otherNames":43},"Placebo to match zanzalintinib oral tablets administered once daily.",[20],null,[45],{"name":46,"affiliation":5,"role":47},"Medical Director","STUDY_DIRECTOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":43,"email":53},"Exelixis Clinical Trials","CONTACT","1-888-393-5494","druginfo@exelixis.com",{"type":55,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[57],{"name":58,"class":6},"Merck Sharp & Dohme LLC","100650637","phase-3-zanzalintinib-alone-or-in-combination-with-pembrolizumab-and-berahyaluronidase-alfa-in-participants-with-colorectal-cancer-with-molecular-residual-disease-100650637",false,"NCT07750158","Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease","Randomized Phase 3 Study of Zanzalintinib ± Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Placebo in Participants With Colorectal Cancer With Stage II\u002FIII Molecular Residual Disease Following Definitive Therapy","STELLAR-316","Key Inclusion Criteria:\n\n* Histologically confirmed diagnosis of Stage II or III adenocarcinoma of colon or rectum.\n* Documented local MSI and\u002For mismatch repair (MMR) test result demonstrating MSS, MSI-low, or pMMR status.\n* Colon or rectal cancer with completed definitive therapy.\n* ctDNA-positive based on local testing using the Natera Signatera tissue-informed molecular residual disease (MRD) assay.\n* 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\u002Fpelvis.\n\nKey Exclusion Criteria:\n\n* History of solid organ or allogeneic stem cell transplant.\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years.\n* Prior treatment with immune checkpoint inhibitors (ICIs) or Vascular endothelial growth factor receptor (VEGFR) inhibitors.\n* History of CRC requiring systemic anticancer therapy prior to the definitive therapy.\n* Use of systemic anticancer therapy (including investigational therapy) or radiation therapy after the completion of definitive therapy.\n* Administration of a live, attenuated vaccine within 30 days of randomization and during treatment.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":70,"type":71},600,"ESTIMATED","INTERVENTIONAL",[74],"PHASE3","The primary objective of this study is to evaluate the effectiveness of zanzalintinib + MK-3475A and zanzalintinib alone compared with placebo.",[77],"Colorectal Cancer",[79,80,81,82,83,84,85,86,87,88,89],"Molecular Residual Disease","Stage II","Stage III","Circulating Tumor Deoxyribose Nucleic Acid (ctDNA) Positive","Signatera Test","Recurrence Prevention","Early Stage Resectable Colorectal Cancer (CRC)","Curative-Intent Therapy","Microsatellite-Stable (MSS)","Microsatellite Instability (MSI) - Low","Mismatch Repair Proficient (pMMR)","NOT_YET_RECRUITING","2026-08-03",{"date":93,"type":94},"2026-08-06","ACTUAL",{"date":93,"type":71},{"date":97,"type":71},"2030-04-05",{"name":5,"class":6}]