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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join 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 cannot join 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Telisotuzumab. An immunoglobulin G1 (IgG1) humanized monoclonal antibody directed against human hepatocyte growth factor receptor (HGFR or c-Met), with potential antineoplastic activity. Telisotuzumab binds to c-Met, thereby preventing both c-Met binding to its ligand, HGF and the subsequent activation of the HGF/c-Met signaling pathway. This may cause cell death in c-Met-expressing tumor cells. c-Met, a receptor tyrosine kinase overexpressed or mutated in many tumor cell types, plays a key role in cancer cell growth, survival, angiogenesis, invasion, and metastasis. NCI Drug Dictionary

pembrolizumab. A humanized monoclonal immunoglobulin (Ig) G4 antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells. The ligands for PD-1 include programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs. Activated PD-1 negatively regulates T-cell activation and plays a key role in in tumor evasion from host immunity. NCI Drug Dictionary

Treatments listed in the registry

• Telisotuzumab Adizutecan (Drug): Intravenous (IV)
• Pembrolizumab (Drug): IV
• Carboplatin (Drug): IV
• Cisplatin (Drug): IV
• Fluorouracil (Drug): IV

Randomized · Parallel · masking: None

Main goals

• Number of Participants with Adverse Events (AE)s (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 (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 (Up to Approximately 67 weeks)

Other goals

• Duration of Response (DoR) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
• Disease Control (DC) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
• OR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
• PFS Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
• DoR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
• DC Rate Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
• Overall Survival (OS)

Planned enrollment: 150 (estimated).

• City Of Hope Comprehensive Cancer Center /ID# 281939, Duarte, California
• City of Hope - Atlanta /ID# 285268, Newnan, Georgia

3 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07744126
• NCI Drug Dictionary: C184368
• NCI Drug Dictionary: C106432

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 26, 2026. Public record; not medical advice.