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

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 arm

Trial Details

NCT ID

NCT07744126

Phase

PHASE2

Sponsor

AbbVie

Status

RECRUITING

Cancer Type

Head and Neck Cancer

Interventions

Telisotuzumab Adizutecan
Pembrolizumab
Carboplatin
Cisplatin
Fluorouracil

Locations (sample)

Duarte, California, United States|34.13945,-117.97729
Newnan, Georgia, United States|33.38067,-84.79966
Kobe, Hyōgo, Japan|34.6913,135.183
Taichung, Taiwan|24.1469,120.6839
Taipei, Taiwan|25.05306,121.52639

Key Eligibility Criteria

Histologically or cytologically confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma that is considered incurable b…
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.

For full eligibility, visit ClinicalTrials.gov.

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