Head and Neck Squamous Cell CarcinomaPhase 2NCT07744126
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 study testing Telisotuzumab Adizutecan, Pembrolizumab and Carboplatin in people with Head and Neck Squamous Cell Carcinoma, run by AbbVie at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Telisotuzumab Adizutecan, Pembrolizumab and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Sep 2026to Oct 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
City Of Hope Comprehensive Cancer Center /ID# 281939
Duarte, California, 91030
- Recruiting
City of Hope - Atlanta /ID# 285268
Newnan, Georgia, 30265
Taiwan2 sites, 2 recruiting
- Recruiting
China Medical University Hospital /ID# 281502
Taichung, 40447
- Recruiting
Taipei Veterans General Hospital /ID# 281531
Taipei, 112
About this study
Official title: 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
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.
Read more
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
- Being tested
- Telisotuzumab Adizutecan, Pembrolizumab, Carboplatin, Cisplatin, Fluorouracil
- Keywords
- Head and Neck Squamous Cell Carcinoma, Telisotuzumab Adizutecan, Pembrolizumab, Cancer
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telisotuzumab AdizutecanDrug
Intravenous (IV)
PembrolizumabDrug
IV
CarboplatinDrug
IV
CisplatinDrug
IV
FluorouracilDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| Telisotuzumab Adizutecan Dose A + Pembrolizumab | Experimental | Participants will receive telisotuzumab adizutecan at Dose A with pembrolizumab, as part of the 67 weeks study duration. Receives: 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. Receives: 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. Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Approximately 67 weeks
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Measured: Up to Approximately 67 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Sep 2026
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744126
- Sponsor's protocol ID
- M26-120
- Other IDs
- 2025-524179-22-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.