RecruitingPhase IIEN originalHead and neck cancerMetastatic / advanced

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Potwierdzony rak głowy i szyi, który nie może być wyleczony standardowymi metodami.
  • •Ogólny stan zdrowia pozwala na normalną aktywność, ale czasem potrzebuje odpoczynku.
  • •Komórki nowotworowe muszą zawierać określone białko (c-Met).

✗ Disqualifies

  • •Przebyte choroby płuc, które wymagały leczenia sterydami.
  • •Poważne, zagrażające życiu choroby.
  • •Przewidywana długość życia krótsza niż 3 miesiące.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
September 29, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (3)

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

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/30/2026.

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