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Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma
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).
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-07-21
Primary completion: 2027-01-01
Study completion finish: 2027-01-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05909904
Intervention or treatment
DRUG: Tislelizumab
DRUG: BGB-A425
DRUG: LBL-007
Conditions
- • Head and Neck Squamous Cell Carcinoma
- • Head and Neck Cancer
Find a site
Closest Location:
Cancer Research South Australia
Research sites nearby
Select from list below to view details:
Cancer Research South Australia
Adelaide, South Australia, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
North Shore Private Hospital
St Leonards, New South Wales, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
ACTIVE_COMPARATOR: Tislelizumab
| DRUG: Tislelizumab
|
EXPERIMENTAL: Tislelizumab + BGB-A425
| DRUG: Tislelizumab
|
EXPERIMENTAL: Tislelizumab + LBL-007
| DRUG: Tislelizumab
|
EXPERIMENTAL: Tislelizumab + BGB-A425 + LBL-007
| DRUG: Tislelizumab
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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 | Up to approximately 3 years and 6 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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 | 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 | 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) | 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 | 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 | Up to approximately 3 years and 6 months |
Overall Survival (OS) | OS is defined as the time from the date of randomization to the date of death due to any cause | Up to approximately 3 years and 6 months |
Number of Participants with Anti-Drug Antibodies (ADAs) | Number of participants with detectable ADAs | Up to approximately 3 years and 6 months |
Frequently Asked Questions
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