Master protocol: The main goal of this master clinical study is to evaluate the efficacy and safety of multiple novel combination therapies in participants with head and neck squamous cell carcinoma (HNSCC) in various substudies. Substudy-01 will evaluate the efficacy and safety of novel combination of treatment regimens, domvanalimab (DOM) and zimberelimab (ZIM) combined with chemotherapy vs ZIM combined with chemotherapy. The primary objective is to assess the efficacy of DOM and ZIM in combination with chemotherapy versus ZIM in combination with chemotherapy.
This platform study will begin with a substudy targeting first-line (1L) recurrent or metastatic (r/m) HNSCC regardless of programmed cell death ligand 1 (PD-L1) expression status (Substudy-01), and new substudies may be added in the future targeting different study populations of HNSCC. All substudies evaluating additional drugs will be added in a staggered manner when relevant nonclinical and/or clinical data become available. Additional drugs may also be added to Substudy-01 in the future.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Siteman Cancer Center
St Louis, Missouri, United States
Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research
Nashville, Tennessee, United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Westmead Hospital
Sydney, New South Wales, Australia
ICON Cancer Center
Kurralta Park, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia
Sichuan Cancer Hospital
Chengdu, China
Zhejiang Cancer Hospital
Hangzhou, China
Guangxi Medical University Cancer Hospital
Nanning, China
...and 13 more locations
Objective response rate (ORR)
ORR is 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)
PFS is 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
Duration of Response (DOR)
DOR is 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
Progression-Free Survival at 6 Months (PFS6)
PFS6 is 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 6 months
Overall Survival (OS)
OS is defined as the time from the date of randomization until the date of death from any cause.
Time frame: Up to 36 months
Overall Survival at 6 Months (OS6)
OS6 is defined as the proportion of participants alive at 6 months from the date of randomization, respectively.
Time frame: Up to 6 months
Overall Survival at 12 Months (OS12)
OS12 is defined as the proportion of participants alive at 12 months from the date of randomization, respectively.
Time frame: Up to 12 months
Disease Control Rate (DCR)
DCR is 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
Time to Progression (TTP)
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.