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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

4 sites in 2 countries

United States2 sites, 2 recruiting

  • City Of Hope Comprehensive Cancer Center /ID# 281939

    Duarte, California, 91030

    Recruiting

  • City of Hope - Atlanta /ID# 285268

    Newnan, Georgia, 30265

    Recruiting

Other trials in United States

Taiwan2 sites, 2 recruiting

  • China Medical University Hospital /ID# 281502

    Taichung, 40447

    Recruiting

  • Taipei Veterans General Hospital /ID# 281531

    Taipei, 112

    Recruiting

Other trials in Taiwan

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.

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.

Study groups in NCT07744126
Study groupRoleWhat they receive
Telisotuzumab Adizutecan Dose A + PembrolizumabExperimentalParticipants 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 + PembrolizumabExperimentalParticipants 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 + FluorouracilActive 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 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.

  1. 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

  2. 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

  3. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted4 Aug 2026
  2. Study start1 Sep 2026
  3. Primary completionOct 2029 (estimated)
  4. Study completionOct 2029 (estimated)

Resources

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)
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.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (AE)s (time frame: Up to Approximately 67 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07744126.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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