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

NCT07744126 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: M26-1202025-524179-22-002025
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and Neck Squamous Cell Carcinoma; Telisotuzumab Adizutecan; Pembrolizumab; Cancer

Outcome Measures

Primary Outcomes (3)

• Number of Participants with Adverse Events (AE)s

  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.

  Up to Approximately 67 weeks

• Objective Response (OR) Rate Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1

  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.

  Up to Approximately 67 weeks

• Progression-Free Survival (PFS) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1

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

  Up to Approximately 67 weeks

Secondary Outcomes (7)

• Duration of Response (DoR) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1

  Up to Approximately 67 weeks

• Disease Control (DC) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1

  Up to Approximately 67 weeks

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

  Up to Approximately 67 weeks

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

  Up to Approximately 67 weeks

• DoR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1

  Up to Approximately 67 weeks

Study Arms (3)

Telisotuzumab Adizutecan Dose A + Pembrolizumab

EXPERIMENTAL

Participants will receive telisotuzumab adizutecan at Dose A with pembrolizumab, as part of the 67 weeks study duration.

Drug: Telisotuzumab Adizutecan; Drug: Pembrolizumab

Telisotuzumab Adizutecan Dose B + Pembrolizumab

EXPERIMENTAL

Participants will receive telisotuzumab adizutecan at Dose B with pembrolizumab, as part of the 67 weeks study duration.

Drug: Telisotuzumab Adizutecan; Drug: Pembrolizumab

Pembrolizumab + Platinum Chemotherapy + Fluorouracil

ACTIVE COMPARATOR

Participants will receive pembrolizumab with standard of care (SOC) platinum chemotherapy (investigator's choice of carboplatin or cisplatin) and fluorouracil (5-FU), as part of the 67 weeks study duration.

Drug: Pembrolizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Fluorouracil

Interventions

Telisotuzumab Adizutecan DRUG

Intravenous (IV)

Telisotuzumab Adizutecan Dose A + Pembrolizumab; Telisotuzumab Adizutecan Dose B + Pembrolizumab

Pembrolizumab DRUG

IV

Pembrolizumab + Platinum Chemotherapy + Fluorouracil; Telisotuzumab Adizutecan Dose A + Pembrolizumab; Telisotuzumab Adizutecan Dose B + Pembrolizumab

Carboplatin DRUG

IV

Pembrolizumab + Platinum Chemotherapy + Fluorouracil

Cisplatin DRUG

IV

Pembrolizumab + Platinum Chemotherapy + Fluorouracil

Fluorouracil DRUG

IV

Pembrolizumab + Platinum Chemotherapy + Fluorouracil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (3)

City Of Hope Comprehensive Cancer Center /ID# 281939

Duarte, California, 91030, United States

RECRUITING

City of Hope - Atlanta /ID# 285268

Newnan, Georgia, 30265, United States

RECRUITING

China Medical University Hospital /ID# 281502

Taichung, 40447, Taiwan

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Neoplasms

Interventions

pembrolizumab; Carboplatin; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (2); TW (1)