Recruiting
Phase 2

Telisotuzumab & Pembrolizumab

Sponsor:

AbbVie

Code:

NCT07744126

Conditions

Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Telisotuzumab Adizutecan

Pembrolizumab

Carboplatin

Cisplatin

Fluorouracil

Study Details

Brief 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 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

Study ID

NCT07744126

Start date

Sep 1, 2026

Status verified date

Sep, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Telisotuzumab Adizutecan Dose A + Pembrolizumab

Participants will receive telisotuzumab adizutecan at Dose A with pembrolizumab, as part of the 67 weeks study duration.

experimental: Telisotuzumab Adizutecan Dose B + Pembrolizumab

Participants will receive telisotuzumab adizutecan at Dose B with pembrolizumab, as part of the 67 weeks study duration.

active comparator: Pembrolizumab + Platinum Chemotherapy + Fluorouracil

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.

Interventions

Telisotuzumab Adizutecan

Intravenous (IV)

Pembrolizumab

IV

Carboplatin

IV

Cisplatin

IV

Fluorouracil

IV

Primary outcome measure

  • Number of Participants with Adverse Events (AE)s [ 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 [ 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 [ Time Frame: Up to Approximately 67 weeks ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

City Of Hope Comprehensive Cancer Center /ID# 281939

Recruiting

Duarte, California, United States, 91030

City of Hope - Atlanta /ID# 285268

Recruiting

Newnan, Georgia, United States, 30265

More Information

Sponsor

AbbVie

Last update posted

Sep 29, 2026

Last verified

Sep, 2026

Keywords

  • Head and Neck Squamous Cell Carcinoma
  • Telisotuzumab Adizutecan
  • Pembrolizumab
  • Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.