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NCT Number: NCT07744126

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 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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anhui Cancer Hospital /ID# 282354, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telisotuzumab Adizutecan

Drug

Intravenous (IV)

Pembrolizumab

Drug

IV

carboplatin

Drug

IV

Cisplatin

Drug

IV

Fluorouracil

Drug

IV

Primary outcomes

  1. Number of Participants with Adverse Events (AE)s

    Time frame: Up to Approximately 38 Months

    An AE is defined as any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.

  2. 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

    OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  3. 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

    PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first.

Secondary outcomes

  1. 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

    DoR is defined as the time from the first objective response (complete response or partial response) to the first occurrence of disease progression or death from any cause, whichever occurs first.

  2. 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

    DC is defined as subjects achieving a best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on BICR assessment per RECIST v1.1.

  3. OR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1

    Time frame: Up to Approximately 38 Months

    OR based on investigator assessment is defined as participants achieving a best overall response of confirmed CR or confirmed PR based on investigator assessment.

  4. PFS Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1

    Time frame: Up to Approximately 38 Months

    PFS is defined as the time from date of randomization to the first documentation of radiographic progressive disease (PD) based on investigator assessment or death from any cause, whichever occurs first.

  5. DoR 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 is defined as the time from the initial response of confirmed CR or confirmed PR based on investigator assessment to radiographic PD based on investigator assessment, or death of any cause, whichever occurs first.

  6. DC Rate Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1

    Time frame: Up to Approximately 38 Months

    DC based on investigator assessment is defined as subjects achieving a best overall response of confirmed CR or confirmed PR, or SD based on investigator assessment.

  7. Overall Survival (OS)

    Time frame: Up to Approximately 38 Months

    OS is defined as the time from randomization to death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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