{"entity":{"id":"nct06082167","kind":"trial","name":"Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","aka":["STELLAR-305"],"tldr":"A phase 2/3 trial testing Zanzalintinib in head and neck squamous cell carcinoma, active and no longer recruiting.","summary":"Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma is a phase 2/3 interventional study registered as NCT06082167, led by Exelixis with Merck Sharp & Dohme, and active but no longer recruiting on the registry. Official title: A Phase 2/3, Randomised, Double-Blind, Controlled Study of Zanzalintinib (XL092) in Combination With Pembrolizumab vs Pembrolizumab in First-Line Treatment of Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. Planned enrolment is 600 participants (estimated). The study started in 2024-06-07 and primary completion is expected in 2028-08. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06082167","url":"https://clinicaltrials.gov/study/NCT06082167"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":["zanzalintinib"],"companies":["exelixis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06082167","phase":"2/3","setting":"A Phase 2/3, Randomized, Double-Blind, Controlled Study of Zanzalintinib (XL092) in Combination With Pembrolizumab vs Pembrolizumab in First-Line Treatment of Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","sponsor":"Exelixis","participation":[{"nct":"NCT06082167","source":"https://clinicaltrials.gov/study/NCT06082167","fetchedAt":"2026-10-07T16:54:11.803Z","studySha256":"0bfd5f661a964510621fe6d39a812b58f6fcc9c20fe61e99f507dc9ffd2a1dcf","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2025-08-17","leadSponsor":"Exelixis","collaboratorCount":1,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":600,"enrolmentType":"ESTIMATED","siteCount":168,"recruitingSiteCount":0,"countries":["Argentina","Australia","Austria","Belgium","Brazil","Bulgaria","Chile","Colombia","Czechia","France","Germany","Greece","Hungary","Israel","Italy","Malaysia","Mexico","Poland","Romania","Slovakia","South Korea","Spain","Taiwan","Thailand","United Kingdom","United States"]}],"started":"2024-06-07","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06082167/","neighbours":{"cancer":[{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"recurrent-metastatic-hnscc","kind":"cancer","name":"Recurrent or metastatic head and neck squamous cell carcinoma","route":"/cancers/recurrent-metastatic-hnscc/"}],"drug":[{"id":"zanzalintinib","kind":"drug","name":"Zanzalintinib","route":"/drugs/zanzalintinib/"}],"company":[{"id":"exelixis","kind":"company","name":"Exelixis","route":"/companies/exelixis/"}]}}