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

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

    trial

    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

    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

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    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/ArmIntervention/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 MeasurePrimary Outcome DescriptionPrimary 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) v1.1Up to approximately 3 years and 6 months

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary 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 firstUp 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 firstUp 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 SDUp to approximately 3 years and 6 months
    Number of Participants with Adverse EventsNumber of participants with adverse events, including laboratory values, vital signs, physical examinations, and electrocardiogram findingsUp 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 causeUp to approximately 3 years and 6 months
    Number of Participants with Anti-Drug Antibodies (ADAs)Number of participants with detectable ADAsUp to approximately 3 years and 6 months

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    References

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

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