Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Conditions
Brief summary
Objective response rate (ORR), defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using investigator assessments [Time Frame: Up to 36 months], Progression-free survival (PFS), defined as the time from the date of randomization until the first date of documented progressive disease (PD) or death from any cause, whichever occurs first, as measured by RECIST v1.1 using investigator assessments [Time Frame: Up to 36 months]
Detailed description
DOR, defined as the time from the date of the first documented response until the first date of documented PD or death from any cause, whichever occurs first, as measured by RECIST v1.1 using investigator assessments. [Time Frame: Up to 36 months], PFS6, defined as the proportion of participants alive and PD-free from date of randomization until 6 months as measured by RECIST v1.1 using investigator assessments. [Time Frame: Up to 36 months], OS, defined as the time from the date of randomization until the date of death from any cause. [Time Frame: Up to 36 months], OS6 and OS12, defined as the proportion of participants alive at 6 months and 12 months from the date of randomization, respectively. [Time Frame: Up to 36 months], DCR, defined as the proportion of participants who achieve a CR, PR, or stable disease (SD) as measured by RECIST v1.1 using investigator assessments. [Time Frame: Up to 36 months], TTP, defined as the time from randomization until the first date of documented PD as measured by RECIST v1.1 using investigator assessments. [Time Frame: Up to 36 months], Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Related TEAEs. [Time Frame: First dose date up to 24 months plus 100 days], Percentage of Participants Experiencing Clinical Laboratory Abnormalities. [Time Frame: First dose date up to 24 months plus 100 days]
Interventions
DRUGDOMVANALIMAB
DRUGZimberelimab
Sponsors
Gilead Sciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR), defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using investigator assessments [Time Frame: Up to 36 months], Progression-free survival (PFS), defined as the time from the date of randomization until the first date of documented progressive disease (PD) or death from any cause, whichever occurs first, as measured by RECIST v1.1 using investigator assessments [Time Frame: Up to 36 months] | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR, defined as the time from the date of the first documented response until the first date of documented PD or death from any cause, whichever occurs first, as measured by RECIST v1.1 using investigator assessments. [Time Frame: Up to 36 months], PFS6, defined as the proportion of participants alive and PD-free from date of randomization until 6 months as measured by RECIST v1.1 using investigator assessments. [Time Frame: Up to 36 months], OS, defined as the time from the date of randomization until the date of death from any cause. [Time Frame: Up to 36 months], OS6 and OS12, defined as the proportion of participants alive at 6 months and 12 months from the date of randomization, respectively. [Time Frame: Up to 36 months], DCR, defined as the proportion of participants who achieve a CR, PR, or stable disease (SD) as measured by RECIST v1.1 using investigator assessments. [Time Frame: Up to 36 months], TTP, defined as the time from randomization until the first date of documented P | — |
Countries
France, Italy, Spain
Outcome results
None listed