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
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
2 other identifiers
interventional
150
5 countries
20
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2026
Typical duration for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2026
CompletedFirst Posted
Study publicly available on registry
August 4, 2026
CompletedStudy Start
First participant enrolled
September 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2029
Study Completion
Last participant's last visit for all outcomes
October 1, 2029
August 4, 2026
July 1, 2026
3 years
July 30, 2026
July 30, 2026
Conditions
Keywords
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 38 Months
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 38 Months
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 38 Months
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 38 Months
Disease Control (DC) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
Up to Approximately 38 Months
OR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
Up to Approximately 38 Months
PFS Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
Up to Approximately 38 Months
DoR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
Up to Approximately 38 Months
- +2 more secondary outcomes
Study Arms (3)
Telisotuzumab Adizutecan Dose A + Pembrolizumab
EXPERIMENTALParticipants will receive telisotuzumab adizutecan at Dose A with pembrolizumab, as part of the 38 month study duration.
Telisotuzumab Adizutecan Dose B + Pembrolizumab
EXPERIMENTALParticipants will receive telisotuzumab adizutecan at Dose B with pembrolizumab, as part of the 38 month study duration.
Pembrolizumab + Platinum Chemotherapy + Fluorouracil
ACTIVE COMPARATORParticipants 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 38 month study duration.
Interventions
Intravenous (IV)
IV
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (20)
University of Arkansas for Medical Sciences /ID# 283444
Little Rock, Arkansas, 72205, United States
Winship Cancer Institute of Emory University /ID# 282003
Atlanta, Georgia, 30322, United States
University of Chicago Medical Center /ID# 281748
Chicago, Illinois, 60637, United States
OU Health - Stephenson Cancer Center /ID# 282905
Oklahoma City, Oklahoma, 73104, United States
UT Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center /ID# 283638
Dallas, Texas, 75235, United States
University of Virginia /ID# 281773
Charlottesville, Virginia, 22908, United States
Anhui Cancer Hospital /ID# 282354
Hefei, Anhui, 230031, China
People's Hospital of Henan Province /ID# 282036
Zhengzhou, Henan, 450003, China
Hunan Province Cancer Hospital /ID# 282346
Changsha, Hunan, 410013, China
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 282115
Xi'an, Shaanxi, 710061, China
Fudan University Shanghai Cancer Center /ID# 282374
Shanghai, Shanghai Municipality, 200032, China
Aichi Cancer Center /ID# 282273
Nagoya, Aichi-ken, 464-8681, Japan
Yokohama City University Hospital /ID# 282274
Yokohama, Kanagawa, 236-0004, Japan
Osaka International Cancer Institute /ID# 282269
Osaka, Osaka, 5418567, Japan
Hospital da Luz /ID# 282666
Lisbon, Lisbon District, 1500-650, Portugal
Unidade Local de Saude de Loures-Odivelas /ID# 281306
Loures, Lisbon District, 2674-514, Portugal
Unidade Local de Saude de Almada-Seixal, EPE /ID# 281288
Almada, Setúbal District, 2805-267, Portugal
Unidade Local de Saude de Santa Maria /ID# 281281
Lisbon, 1649-035, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 281282
Porto, 4200-072, Portugal
Hospital Universitario de Salamanca /ID# 282672
Salamanca, 37007, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
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 (Estimated)
September 30, 2026
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
October 1, 2029
Last Updated
August 4, 2026
Record last verified: 2026-07
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/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.