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Triple immunotherapy cocktail shows promise against tough cancers

NCT ID NCT03744468

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested combinations of three immunotherapy drugs—tislelizumab, surzebiclimab, and alcestobart—in 147 adults with advanced solid tumors that had not responded to prior treatments. The goal was to find safe doses and see if the drugs could shrink tumors. The trial is now complete, and results will help guide future research on these combinations.

What this could mean

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

Active substance
tislelizumab, surzebiclimab, and alcestobart (three immunotherapy drugs that help the immune system attack cancer)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so results may not apply to all patients. Side effects from immunotherapy can be serious, including immune-related inflammation in healthy organs.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

147 people

The number who actually took part.

Started

Nov 2018

Finished

Feb 2025

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.

Key Inclusion Criteria: * Participants were aged \>=18 years. * Adequate organ function. * Eastern Cooperative Oncology Group (ECOG) performance status \<=1. * Must have been able to provide a recently obtained archival tumor tissue or fresh tumor biopsy. * The phase 1 dose escalation and phase 2 safety lead-in enrolled participants with histologically/cytologically confirmed advanced/metastatic solid tumors who had previously received standard systemic therapy per local guidelines, unless it was not available, not tolerated or determined not appropriate based on investigators judgement, and had at least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * The phase 2 dose expansion enrolled participants with recurrent/metastatic HNSCC (Cohorts 1 and 4) and advanced/metastatic NSCLC (Cohorts 2 and 5), with disease progression that occurred \>=10 weeks from the initiation of anti-PD-1/PD-L1 treatment for locally advanced or metastatic disease and had at least 1 measurable lesion outside of the central nervous system per RECIST v1.1. Key Exclusion Criteria: * A history of severe hypersensitivity reactions to other monoclonal antibodies. * Active autoimmune disease or a history of autoimmune diseases that might relapse or a history of life-threatening toxicity related to prior immune therapy. * Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication \<=14 days before administration of study drug. * A history of interstitial lung disease, noninfectious pneumonitis or uncontrolled lung diseases. * Prior therapy targeting TIM-3 and/or LAG-3. * The phase 2 dose expansion NSCLC cohorts excluded participants with known sensitizing epidermal growth factor receptor (EGFR) mutation, v-raf murine sarcoma viral oncogene homolog B1 (BRAF) mutation, anaplastic lymphoma kinase (ALK) fusion, or c-ros oncogene 1 (ROS1) fusion. NOTE: Other protocol defined Inclusion/Exclusion criteria might apply.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

HNSCC for phase 2 dose expansion Locally advanced or metastatic solid tumors for phase 1, dose escalation and phase 2 safety lead-in Locally advanced or metastatic solid tumors for phase 1,dose escalation and phase 2 safety lead-in, HNSCC, NSCLC and RCC participants for phase 2 NSCLC for phase 2 dose expansion

Contacts and locations

Locations

  • Ajou University Hospital

    Suwon, 16499, South Korea

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

  • Box Hill Hospital

    Box Hill, Victoria, VIC 3128, Australia

  • Cabrini Research and Education Institute

    Malvern, Victoria, VIC 3144, Australia

  • Calvary North Adelaide Hospital

    North Adelaide, South Australia, SA 5006, Australia

  • Centre de Lutte Contre Le Cancer Francois Baclesse

    Caen, 14000, France

  • Centre de Lutte Contre Le Cancer Institut Bergonie

    Bordeaux, 33000, France

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868-3201, United States

  • Chungbuk National University Hospital

    SeowonGu CheongjuSi, Chungcheongbukdo, 28644, South Korea

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, 20133, Italy

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2434, United States

  • Gachon University Gil Medical Center

    NamdongGu, Incheon Gwang'Yeogsi, 21565, South Korea

  • Gold Coast University Hospital

    Southport, Queensland, QLD 4215, Australia

  • Hollywood Private Hospital

    Nedlands, Western Australia, WA 6009, Australia

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario Hm Madrid Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Institut Catala Doncologia

    Barcelona, 08908, Spain

  • Institut Curie Paris

    Paris, 75005, France

  • Irccs Azienda Ospedaliero Universitaria Bologna

    Bologna, 40138, Italy

  • Istituto Di Candiolo Irccs

    Torino, 10060, Italy

  • Linear Clinical Research

    Nedlands, Western Australia, WA 6009, Australia

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, SA 5112, Australia

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, VIC 3000, Australia

  • Schar Cancer Institute

    Fairfax, Virginia, 22031-4867, United States

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

  • Sunshine Coast Hospital and Health Service

    Birtinya, Queensland, QLD 4575, Australia

  • Sydney Southwest Private Hospital

    Liverpool, New South Wales, NSW 2170, Australia

  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi, 06591, South Korea

  • The Catholic University of Korea, St Vincents Hospital

    PaldalGu SuwonSi, Gyeonggi-do, 16247, South Korea

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009, United States

  • Ulsan University Hospital

    Donggu, Ulsan Gwang'Yeogsi, 44033, South Korea

  • University of Chicago Medical Center

    Chicago, Illinois, 60637-1443, United States

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045-2517, United States

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky, 40536-7001, United States

  • University of North Carolina At Chapel Hill

    Chapel Hill, North Carolina, 27514-4220, United States

  • University of Virginia

    Charlottesville, Virginia, 22908-0817, United States

  • Ut Health San Antonio Mays Cancer Center

    San Antonio, Texas, 78229-4427, United States

  • Weill Cornell Medical College Newyork Presbyterian Hospital

    New York, New York, 10065-4870, United States

  • Western Health Sunshine Hospital

    St Albans, Victoria, VIC 3021, Australia

More trials for these conditions

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