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New immunotherapy cocktail takes on head and neck cancer

NCT ID NCT05909904

Disease control Sponsor: BeiGene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 4 times

Summary

This phase 2 trial is testing whether combining the immunotherapy drug tislelizumab with other experimental drugs (surzebiclimab or alcestobart) can shrink tumors or slow cancer growth in people with advanced head and neck cancer that has come back or spread. About 160 participants who have not had prior treatment for their advanced cancer will receive one of the combinations. The study measures how many patients respond and how long the response lasts.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tislelizumab (immunotherapy) combined with surzebiclimab or alcestobart
What this could lead to
If successful, this could lead to a new first-line treatment option that shrinks tumors or delays cancer growth in people with advanced head and neck cancer.
What could go wrong
This is an early-phase trial with only 160 participants, so results may not apply to everyone. The drug combinations may cause side effects like immune-related inflammation, and there is no guarantee of benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

160 people

The number who actually took part.

Started

Aug 2023

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 programmed cell death protein ligand-1 (PD-L1) expression (Combined Positive Score \[CPS\] ≥ 1) * Have at least 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (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-programmed cell death protein-1 (anti-PD-1), anti-PD-L1, anti-programmed cell death ligand-2 (PD-L2), T-cell immunoglobulin and mucin-domain containing-3 (TIM-3), lymphocyte activation gene-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

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck cancer Head and neck squamous cell carcinoma

Contacts and locations

Locations

  • Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital

    Hefei, Anhui, 230088, China

  • Arensia Exploratory Medicine Llc

    Tbilisi, 0112, Georgia

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Beijing Tongren Hospital, Cmu

    Beijing, Beijing Municipality, 100010, China

  • British Columbia Cancer Agency the Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Cancer Care Northwest

    Spokane Valley, Washington, 99216, United States

  • Cancer Research South Australia

    Adelaide, South Australia, 5000, Australia

  • Centre Antoine Lacassagne

    Nice, 06100, France

  • Changhua Christian Hospital

    Changhua, 50006, Taiwan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Florida Cancer Specialist Research Institute Lake Nona

    Orlando, Florida, 32827, United States

  • Florida Cancer Specialist Research Institute Panhandle

    Tallahassee, Florida, 32308, United States

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, 20133, Italy

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Gold Coast Private Hospital

    Gold Coast, Queensland, 4215, Australia

  • Greenslopes Private Hospital

    Greenslopes, Queensland, 4120, Australia

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Ico Lhospitalet Hospital Duran I Reynals

    Barcelona, 08908, Spain

  • Ico Site Rene Gauducheau

    SaintHerblain, 44805, France

  • Institut Curie Paris

    Paris, 75005, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Istituto Europeo Di Oncologia

    Milan, 20141, Italy

  • Keimyung University Dongsan Hospital

    Dalseogu, Daegu Gwang'yeogsi, 42601, South Korea

  • Medical Park Izmir Hospital

    Izmir, 35575, Turkey (Türkiye)

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408, South Korea

  • National Cancer Centre Singapore

    Singapore, 168583, Singapore

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • Nepean Hospital

    Kingswood, New South Wales, 2747, Australia

  • North Shore Private Hospital

    St Leonards, New South Wales, 2065, Australia

  • Northeast Health Wangaratta

    Wangaratta, Victoria, 3677, Australia

  • Northwest Cancer Specialist, Pc(Us Oncology Research)

    Vancouver, Washington, 98684, United States

  • Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)

    Blacksburg, Virginia, 24060, United States

  • Ramathibodi Hospital Mahidol University

    Bangkok, 10400, Thailand

  • Rocky Mountain Cancer Centers, Llp(Us Oncology Research)

    Lone Tree, Colorado, 80124, United States

  • Royal Marsden Hospital

    London, SW3 6JJ, United Kingdom

  • Royal Marsden Hospital Sutton

    Sutton, SM2 5PT, United Kingdom

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Scientific Institute of Pavia Maugeri

    Pavia, 27100, Italy

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120, China

  • Sichuan Cancer Hospital and Institute

    Chengdu, Sichuan, 610041, China

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Songklanagarind Hospital (Prince of Songkhla University)

    Hat Yai, 90110, Thailand

  • Srinagarind Hospital (Khon Kaen University)

    Muang, 40002, Thailand

  • St John of God, Murdoch

    Murdoch, Western Australia, 6150, Australia

  • Stanford Medicine

    Stanford, California, 94305, United States

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 630014, China

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6, Canada

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011, China

  • The Tumor Hospital Affiliated to Guangxi Medical University

    Nanning, Guangxi, 530021, China

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

  • Tr Trakya University Health Research and Application Center (Hospital)

    Edirne, 22030, Turkey (Türkiye)

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky, 40536, United States

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067, United States

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.