Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
Head and Neck Squamous Cell Carcinoma, Telisotuzumab Adizutecan, Pembrolizumab, Cancer
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 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.
Interventions
DRUGTelisotuzumab Adizutecan
Intravenous (IV)
DRUGPembrolizumab
IV
DRUGCarboplatin
IV
DRUGCisplatin
IV
DRUGFluorouracil
IV
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AE)s | Up to Approximately 38 Months | 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. |
| Objective Response (OR) Rate Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 | Up to Approximately 38 Months | 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. |
| Progression-Free Survival (PFS) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 | Up to Approximately 38 Months | PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DoR) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 | Up to Approximately 38 Months | 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. |
| Disease Control (DC) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 | Up to Approximately 38 Months | 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. |
| OR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 | Up to Approximately 38 Months | OR based on investigator assessment is defined as participants achieving a best overall response of confirmed CR or confirmed PR based on investigator assessment. |
| PFS Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 | Up to Approximately 38 Months | 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. |
| DoR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 | Up to Approximately 38 Months | 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. |
| DC Rate Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 | Up to Approximately 38 Months | 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. |
| Overall Survival (OS) | Up to Approximately 38 Months | OS is defined as the time from randomization to death from any cause. |
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed