InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

Closed (no longer recruiting)Last updated: 13 November 2024

BGB-HNSCC-201: This study is evaluating how safe and effective immunotherapy is when given alone or in combination with new cancer drugs in people with first-line recurrent or metastatic squamous cell cancer of the head and neckA Randomized, Phase 2, Open-Label, Multi-Arm Study of Tislelizumab in Combination With Investigational Agents as First-Line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Clinical summary

Summary

Eligible participants will be randomly allocated to one of four treatment arms that are evaluating immunotherapy (called tislelizumab) alone or in combination with other new, experimental drugs.

In Arm A (Active Comparator), participants will receive tislelizumab alone, which will be administered intravenously once every 3 weeks.

In Arm B (Experimental), participants will receive tislelizumab plus a new drug (called BGB-A425), both to be administered intavenously once every 3 weeks.

In Arm C (Experimental), participants will receive tislelizumab plus a new drug (called LBL-007), both to be administered intravenously once every 3 weeks.

In Arm D (Experimetnal), partcipants will receive tislelizumab plus two new drugs (BGB-A425 and LBL-007), all to be administered intravenously once every 3 weeks. 

Conditions

This trial is treating patients with head and neck squamous cell carcinoma who have not received treatment for their recurrent or metastatic disease

Cancer

Head and Neck Cancers Head and Neck

Age

People18+

Phase

II

Trial Acronym

BGB-HNSCC-201

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

BeiGene

Scientific Title

A Randomized, Phase 2, Open-Label, Multi-Arm Study of Tislelizumab in Combination With Investigational Agents as First-Line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Eligibility

Inclusion

  • Participants with histologically or cytologically confirmed R/M HNSCC that is considered incurable by local therapies

    1. The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx
    2. 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

  • 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

Note: Other inclusion and exclusion criteria may apply

Inclusion

  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

Closed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Know more about Cancer Connect

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Get support

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

More info for carers

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.