A Study to Assess Adverse Events, Change in Disease Activity and Optimal Dose of Intravenous (IV) Telisotuzumab Adizutecan With IV Pembrolizumab for First-Line Treatment of Adult Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

StatusRecruiting
PhasePhase 2
SponsorAbbVie
Started

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Record History

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  1. Minor Study sites: 3 to 4
  2. Minor Re-verified, no change to tracked fields
  3. Notable Recruitment opened Show 4 more changesShow less
    • Trial sites expanded: 0 → 3 locations
    • Start date changed from estimate of Sep 30, 2026 to Sep 1, 2026
    • Eligibility criteria shortened, about 10 words
    • Secondary endpoints: details revised at 7 of 7 entries
  4. Minor Trial sites reduced: 20 → 0 locationsv2
  5. Minor Study First Submitted
  • 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.
349 trials monitored
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Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer worldwide with an annual incidence of approximately 700,000 cases. This study aims to evaluate the change in disease activity and optimal dose, and optimal dose of telisotuzumab adizutecan in combination with pembrolizumab as first-line treatment in participants with recurrent or metastatic head and neck squamous cell carcinoma. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of recurrent or metastatic HNSCC. Participants are placed into 3 treatment groups called treatment arms. Each group receives a different treatment. Adult participants diagnosed with recurrent or metastatic HNSCC who have not received prior systemic therapy for advanced disease and whose tumors express c-Met protein will be enrolled. Approximately 180 participants will be enrolled in the study at sites worldwide. Participants will receive intravenous doses of telisotuzumab adizutecan with intravenous pembrolizumab, or standard of care (SOC) chemotherapy with pembrolizumab. Participants will receive treatment as part of a 67 weeks study duration. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits every 3 weeks during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Trial Details
NCT Number NCT07744126
Lead Sponsor AbbVie
Conditions
(from sponsor)
Head and Neck Squamous Cell Carcinoma
Related terms Neoplasms, Squamous Cell Carcinoma of Head and Neck
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov