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. Complete response is defined as disappearance of all target lesions, disappearance of all nontarget lesions and normalization of tumor marker level, and no new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, no unequivocal progression of non-target lesions, and no new lesions.
Time frame: Up to 21.2 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 (PD) assessed by the investigators per RECIST v1.1 or death, whichever occurred first. PD is defined as at least a 20% increase in the sum of diameters of target lesions, unequivocal progression of existing non-target lesions, or new lesions.
Time frame: Up to 21.2 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 occurred first.
Time frame: Up to 21.2 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 durable stable disease (SD) (SD duration ≥ 24 weeks). SD is defined as neither sufficient decrease in size of target lesions to qualify for PR nor sufficient increase to qualify for PD, no progressive disease in nontarget lesions, and no new lesions.
Time frame: Up to 21.2 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.
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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
Time frame: Up to 21.2 months
Number of Participants With Treatment-Emergent Adverse Events
Number of participants with adverse events (AEs), including laboratory values, vital signs, physical examinations, and electrocardiogram findings. AEs were graded on a scale of Grade 1 to Grade 5, with Grade 1 being least severe and Grade 5 being most severe. An AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether considered related to study drug or not. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was considered a significant medical AE by the investigator based on medical judgement.
Time frame: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months.
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 21.2 months