Telisotuzumab Adizutecan with Pembrolizumab as first-line treatment for recurrent or metastatic head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 trial evaluates the safety and activity of telisotuzumab adizutecan plus pembrolizumab, with or without chemotherapy, as first-line therapy for adults with recurrent or metastatic head and neck squamous cell carcinoma. Participants must have tumors expressing c-Met and no prior systemic therapy for advanced disease. The study randomizes participants into three arms to explore different dose levels and regimens while monitoring adverse events and changes in disease activity using RECIST 1.1 criteria. Approximately 180 participants are planned to enroll across multiple sites worldwide, including centers in the United States and Japan. The sponsor is AbbVie, with collaborative sites at City of Hope and Kobe University Hospital.

Why it matters

Who can join: the full rules

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.

Where it's running

• City Of Hope Comprehensive Cancer Center /ID# 281939
  Duarte, California, United States Recruiting
• City of Hope - Atlanta /ID# 285268
  Newnan, Georgia, United States Recruiting
• Kobe University Hospital /ID# 281770
  Kobe, Hyōgo, Japan Recruiting
• China Medical University Hospital /ID# 281502
  Taichung, Taiwan Recruiting
• Taipei Veterans General Hospital /ID# 281531
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.