A Phase 2 interventional study of Telisotuzumab Adizutecan and Pembrolizumab in Head and Neck Squamous Cell Carcinoma, sponsored by AbbVie. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
Participants will receive telisotuzumab adizutecan at Dose A with pembrolizumab, as part of the 67 weeks study duration.
Drug: Telisotuzumab Adizutecan · Drug: Pembrolizumab
Participants will receive telisotuzumab adizutecan at Dose B with pembrolizumab, as part of the 67 weeks study duration.
Drug: Telisotuzumab Adizutecan · Drug: Pembrolizumab
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
Intravenous (IV)
IV
IV
IV
IV
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Approximately 67 weeks
Duration of Response (DoR) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
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.
Time frame: 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
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.
Time frame: Up to Approximately 67 weeks
OR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
OR based on investigator assessment is defined as participants achieving a best overall response of confirmed CR or confirmed PR based on investigator assessment.
Time frame: Up to Approximately 67 weeks
PFS Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
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.
Time frame: Up to Approximately 67 weeks
DoR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
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.
Time frame: Up to Approximately 67 weeks
DC Rate Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
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.
Time frame: Up to Approximately 67 weeks
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Time frame: Up to Approximately 67 weeks
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
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