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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Telisotuzumab Adizutecan, Pembrolizumab, Carboplatin, Cisplatin.
- Who it may be relevant to
- Registry conditions: Head and Neck Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China, Japan, Portugal, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 2 Open-Label Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Pembrolizumab as First-Line Treatment in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Overview
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 38 month 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.
Interventions
- Drug Telisotuzumab Adizutecan
Intravenous (IV) - Drug Pembrolizumab
IV - Drug Carboplatin
IV - Drug Cisplatin
IV - Drug Fluorouracil
IV
Primary outcome measures
- Number of Participants with Adverse Events (AE)s [Time frame: Up to Approximately 38 Months]
- Objective Response (OR) Rate Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: Up to Approximately 38 Months]
- Progression-Free Survival (PFS) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: Up to Approximately 38 Months]
Secondary outcome measures (7)
- Duration of Response (DoR) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: Up to Approximately 38 Months]
- Disease Control (DC) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: Up to Approximately 38 Months]
- OR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: Up to Approximately 38 Months]
- PFS Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: Up to Approximately 38 Months]
- DoR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: Up to Approximately 38 Months]
- DC Rate Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: Up to Approximately 38 Months]
- Overall Survival (OS) [Time frame: Up to Approximately 38 Months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- University of Arkansas for Medical Sciences /ID# 283444 — Little Rock
- Winship Cancer Institute of Emory University /ID# 282003 — Atlanta
- University of Chicago Medical Center /ID# 281748 — Chicago
- OU Health - Stephenson Cancer Center /ID# 282905 — Oklahoma City
- UT Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center /ID# 283638 — Dallas
- University of Virginia /ID# 281773 — Charlottesville
China · 5 centers
- Anhui Cancer Hospital /ID# 282354 — Hefei
- People's Hospital of Henan Province /ID# 282036 — Zhengzhou
- Hunan Province Cancer Hospital /ID# 282346 — Changsha
- The First Affiliated Hospital of Xi'an Jiaotong University /ID# 282115 — Xi'an
- Fudan University Shanghai Cancer Center /ID# 282374 — Shanghai
Portugal · 5 centers
- Hospital da Luz /ID# 282666 — Lisbon
- Unidade Local de Saude de Loures-Odivelas /ID# 281306 — Loures
- Unidade Local de Saude de Almada-Seixal, EPE /ID# 281288 — Almada
- Unidade Local de Saude de Santa Maria /ID# 281281 — Lisbon
- Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 281282 — Porto
Japan · 3 centers
- Aichi Cancer Center /ID# 282273 — Nagoya
- Yokohama City University Hospital /ID# 282274 — Yokohama
- Osaka International Cancer Institute /ID# 282269 — Osaka
Spain · 1 center
- Hospital Universitario de Salamanca /ID# 282672 — Salamanca
Identifiers
NCT: NCT07744126 · M26-120 · 2025-524179-22-00