A Study of Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma
- Conditions
- Head and Neck Squamous Cell CarcinomaHead and Neck Cancer
- Interventions
- Registration Number
- NCT05909904
- Lead Sponsor
- BeiGene
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 160
-
Participants with histologically or cytologically confirmed R/M HNSCC that is considered incurable by local therapies
- The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx
- Participants should not have had prior systemic therapy administered in the R/M setting; systemic therapy which was completed prior to randomization/enrollment if given as part of multimodal treatment for locally or locoregionally advanced disease is allowed
-
Participants must have positive PD-L1 expression (Combined Positive Score [CPS] ≥ 1)
-
Have at least 1 measurable lesion as defined per RECIST v1.1
-
Eastern Cooperative Oncology Group Performance Status of 0 or 1
-
Adequate hematologic and organ function as indicated by specific laboratory values within 7 days of first dose of study drug
-
Willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of study drug(s)
- Recurrent or metastatic carcinoma of the nasopharynx (any histology), squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland primary tumor or non-squamous histologies (eg, mucosal melanoma)
- Prior therapy with an anti-PD-1, anti-PD-L1, PD-L2, T-cell immunoglobulin and TIM-3, LAG-3, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
- Any active malignancy ≤ 2 years before randomization/enrollment except for the specific cancer under investigation in this study, those with a negligible risk of metastasis or death, and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, localized prostate cancer, and carcinoma in situ of the cervix or breast)
- History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, and acute lung diseases
- A history of severe hypersensitivity reactions to other monoclonal antibodies or has experienced a severe immune-mediated adverse event (imAE), an imAE that led to treatment discontinuation, or a cardiac or ocular imAE of any grade with prior immunotherapy
Note: Other inclusion and exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tislelizumab Tislelizumab Tislelizumab 200 milligrams (mg) administered once every 3 weeks Tislelizumab + BGB-A425 Tislelizumab Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 Tislelizumab + BGB-A425 BGB-A425 Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 Tislelizumab + LBL-007 Tislelizumab Tislelizumab 200 mg administered once every 3 weeks with LBL-007 Tislelizumab + LBL-007 LBL-007 Tislelizumab 200 mg administered once every 3 weeks with LBL-007 Tislelizumab + BGB-A425 + LBL-007 Tislelizumab Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 and LBL-007 Tislelizumab + BGB-A425 + LBL-007 BGB-A425 Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 and LBL-007 Tislelizumab + BGB-A425 + LBL-007 LBL-007 Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 and LBL-007 Tislelizumab Tislelizumab Tislelizumab 200 milligrams (mg) administered once every 3 weeks Tislelizumab + BGB-A425 Tislelizumab Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 Tislelizumab + LBL-007 Tislelizumab Tislelizumab 200 mg administered once every 3 weeks with LBL-007 Tislelizumab + BGB-A425 + LBL-007 Tislelizumab Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 and LBL-007 Tislelizumab + BGB-A425 + LBL-007 LBL-007 Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 and LBL-007 Tislelizumab + LBL-007 LBL-007 Tislelizumab 200 mg administered once every 3 weeks with LBL-007 Tislelizumab + BGB-A425 + LBL-007 BGB-A425 Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 and LBL-007 Tislelizumab + BGB-A425 BGB-A425 Tislelizumab 200 mg administered once every 3 weeks with BGB-A425
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) Up to approximately 3 years and 6 months 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
- Secondary Outcome Measures
Name Time Method Progression-free Survival (PFS) Up to approximately 3 years and 6 months 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
Duration of Response (DOR) Up to approximately 3 years and 6 months 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
Clinical Benefit Rate (CBR) Up to approximately 3 years and 6 months 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)
Disease Control Rate (DCR) Up to approximately 3 years and 6 months DCR is defined as the percentage of participants with a best overall response of a confirmed CR, a confirmed PR, or SD
Number of Participants with Adverse Events Up to approximately 3 years and 6 months Number of participants with adverse events, including laboratory values, vital signs, physical examinations, and electrocardiogram findings
Overall Survival (OS) Up to approximately 3 years and 6 months OS is defined as the time from the date of randomization to the date of death due to any cause
Trial Locations
- Locations (73)
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
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