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Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma

PHASE2RECRUITING

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).

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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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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)

Exclusion criteria

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 mucin domain containing-3 (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

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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

Image related to Head and Neck Squamous Cell Carcinoma

Condition: Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer
DRUG: Tislelizumab and other drugs
Adelaide, South Australia, Australia and more
Sponsor: BeiGene

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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 Tislelizumab 200 milligrams (mg) administered once every 3 weeks	DRUG: Tislelizumab Administered intravenously
EXPERIMENTAL: Tislelizumab + BGB-A425 Tislelizumab 200 mg administered once every 3 weeks with BGB-A425	DRUG: Tislelizumab Administered intravenously
EXPERIMENTAL: Tislelizumab + LBL-007 Tislelizumab 200 mg administered once every 3 weeks with LBL-007	DRUG: Tislelizumab Administered intravenously
EXPERIMENTAL: Tislelizumab + BGB-A425 + LBL-007 Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 and LBL-007	DRUG: Tislelizumab Administered intravenously

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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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma