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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

RecruitingPhase 2Ages 18 Years - anyAllAbbVie
NCT07744126 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 sit

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📋 Eligibility rules (as published)
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma that is considered incurable by local therapies. * Eastern cooperative oncology group (ECOG) performance status must be \<= 1. * Must have c-Met protein expression by central c-Met immunohistochemistry (IHC) staining at any intensity in \>= 25% tumor cells. * Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1. * Must have had no prior systemic therapy for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Exclusion Criteria: * Have history of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis on screening chest computed tomography (CT) scan. * Have any major, life-threatening conditions. * Life expectancy should be at least 3 months.
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What it tests

  • Telisotuzumab Adizutecan
  • Pembrolizumab
  • Carboplatin
  • Cisplatin
  • Fluorouracil
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Where

4 sites
City Of Hope Comprehensive Cancer Center /ID# 281939
Duarte, United States
City of Hope - Atlanta /ID# 285268
Newnan, United States
China Medical University Hospital /ID# 281502
Taichung, Taiwan
Taipei Veterans General Hospital /ID# 281531
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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