This study is designed to evaluate the efficacy and safety of tislelizumab and tislelizumab in combination with investigational agent(s) in first-line recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
This study will test whether tislelizumab alone and combined with other investigational agents can be used to improve treatment outcomes in participants with head and neck squamous cell carcinoma. The main goals of the study are to determine how many participants may no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment and to determine what adverse events, or side effects, participants might experience. Tislelizumab is used to block the programmed cell death protein-1 pathway so that immune system cells (T-cells) can better protect the body from infection and find tumor cells to attack. Tislelizumab may be used in combination with other therapies as a promising approach with potential therapeutic benefits to treat participants with cancer. The study will enroll approximately 160 participants. Participants will be randomly assigned (by chance, similar to flipping a coin) to one of the various treatment groups. Tislelizumab and investigational agents will be administered as an infusion through a vein at regularly scheduled intervals. The study will take place at multiple centers worldwide. Treatments will continue until participants experience no benefits, too many side effects, or withdraw consent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Administered intravenously
Administered intravenously
Administered intravenously
Objective Response Rate (ORR)
ORR is defined as percentage of participants who have a confirmed complete response (CR) or a confirmed partial response (PR) as assessed by the investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to approximately 3 years and 6 months
Progression-free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease assessed by the investigators per RECIST v1.1 or death, whichever occurs first
Time frame: Up to approximately 3 years and 6 months
Duration of Response (DOR)
DOR is defined as the time from the first determination of a confirmed response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first
Time frame: Up to approximately 3 years and 6 months
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with a best overall response of a confirmed CR, a confirmed PR, or a durable stable disease (SD) (SD duration ≥ 24 weeks)
Time frame: Up to approximately 3 years and 6 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with a best overall response of a confirmed CR, a confirmed PR, or SD
Time frame: Up to approximately 3 years and 6 months
Number of Participants with Adverse Events
Number of participants with adverse events, including laboratory values, vital signs, physical examinations, and electrocardiogram findings
Time frame: Up to approximately 3 years and 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Valkyrie Clinical Trials
Los Angeles, California, United States
Stanford Medicine
Stanford, California, United States
Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
Lone Tree, Colorado, United States
Florida Cancer Specialist Research Institute Lake Nona
Orlando, Florida, United States
Florida Cancer Specialist Research Institute Panhandle
Tallahassee, Florida, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
Blacksburg, Virginia, United States
Cancer Care Northwest
Spokane Valley, Washington, United States
Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver, Washington, United States
Nepean Hospital
Kingswood, New South Wales, Australia
...and 63 more locations
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause
Time frame: Up to approximately 3 years and 6 months