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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
AbbVie
Study ID
NCT07744126
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Telisotuzumab Adizutecan — DRUG
    Intravenous (IV)
  • Pembrolizumab — DRUG
    IV
  • Carboplatin — DRUG
    IV
  • Cisplatin — DRUG
    IV
  • Fluorouracil — DRUG
    IV

Study Details

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.

Key Dates

First listed
Aug 4, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Telisotuzumab Adizutecan Dose A + Pembrolizumab
    Participants will receive telisotuzumab adizutecan at Dose A with pembrolizumab, as part of the 38 month study duration.
  • Experimental: Telisotuzumab Adizutecan Dose B + Pembrolizumab
    Participants will receive telisotuzumab adizutecan at Dose B with pembrolizumab, as part of the 38 month 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 38 month study duration.

Primary Outcome Measure

Number of Participants with Adverse Events (AE)s [ Time Frame: Up to Approximately 38 Months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical Sciences /ID# 283444Little RockArkansas72205-
Winship Cancer Institute of Emory University /ID# 282003AtlantaGeorgia30322-
University of Chicago Medical Center /ID# 281748ChicagoIllinois60637-
OU Health - Stephenson Cancer Center /ID# 282905Oklahoma CityOklahoma73104-
UT Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center /ID# 283638DallasTexas75235-
University of Virginia /ID# 281773CharlottesvilleVirginia22908-

Find similar trials in Little Rock, AR

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By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Arkansas for Medical Sciences· Little Rock, ARWinship Cancer Institute of Emory University· Atlanta, GAUniversity of Chicago Medical Center· Chicago, ILOU Health - Stephenson Cancer Center· Oklahoma City, OKUT Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center· Dallas, TXUniversity of Virginia· Charlottesville, VA

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