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Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Study acronym: STELLAR-305
StatusActive, Not Recruiting
PhasePhase 2/3
SponsorExelixis
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Eligibility criteria expanded, about 6 words · Site details revised at 168 of 168 sitesv12 Show 2 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Site details revised at 168 of 168 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 165 to 168v11
  3. Study sites: 134 to 165v10
  4. Primary completion date: Jun 2027 to Aug 2028 Primary endpoints revised (2) · Enrollment target: 500 to 600 · Study sites: 68 to 134 · 4 morev9 Show 7 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 500 to 600
    • Study sites: 68 to 134
    • Completion date: Mar 2028 to Mar 2029
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (3)
    • Collaborators expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 54 to 68v8
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Nov 30, 2023 to Jun 7, 2024v7
  2. Study sites: 25 to 54v6
  3. Study sites: 20 to 25v5
  4. Study sites: 1 to 20v4
  5. Start date changed from estimate of Dec 2023 to Nov 30, 2023v3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary completion date: May 2027 to Jun 2027 · Completion date: Dec 2027 to Mar 2028 · 1 morev2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: May 2027 to Jun 2027
    • Completion date: Dec 2027 to Mar 2028
    • Start date: Nov 2023 to Dec 2023
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Exelixis
25 trials monitored
See 2 trials at risk
Head & Neck Cancer
2,060 trials monitored
See 120 trials at risk
This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched placebo in combination with pembrolizumab in subjects with programmed death-ligand 1 (PD-L1) positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) incurable by local therapies who have not received prior systemic therapy for recurrent or metastatic disease.
Trial Details
NCT Number NCT06082167
Lead Sponsor Exelixis
Collaborators: Merck Sharp & Dohme LLC
Conditions Head and Neck Squamous Cell Carcinoma
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov