A Study to Assess Adverse Events, Change in Disease Activity and Optimal Dose of Intravenous (IV)… (NCT07744126) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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
150 participantsStarted 2026-09-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a combination of two IV drugs — telisotuzumab adizutecan and pembrolizumab — as a first-line treatment, meaning before any other treatment for my recurrent or metastatic head and neck squamous cell carcinoma. How does this compare to the standard first-line treatment options I should also be considering right now?
2Since this is a Phase 2 trial, the researchers are still working out the optimal dose of telisotuzumab adizutecan and gathering early safety data — so what is currently known about the side effects of this drug combination, and what risks should I be prepared for?
3The trial is listed as 'not yet recruiting,' so it hasn't started enrolling patients yet — do you know when it might open, which sites might offer it, and whether waiting for it to begin could affect my treatment timeline?
4One of the main things this trial is measuring is how many participants experience adverse events — what does that tell us about where the researchers are in understanding how safe this combination is, and how should that factor into my decision?
5Pembrolizumab is already used in head and neck cancer treatment, but telisotuzumab adizutecan appears to be newer in this setting — can you help me understand what role the c-Met target that this drug is designed to address might play in my specific cancer, and whether that affects whether this trial could be relevant to my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Adverse Events (AE)s
Timeframe: Up to Approximately 38 Months
2
Objective Response (OR) Rate Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1
Timeframe: Up to Approximately 38 Months
3
Progression-Free Survival (PFS) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1