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New drug cocktail shows promise against tough head and neck cancer

NCT ID NCT04665843

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tested whether adding tiragolumab to atezolizumab (Tecentriq) helps shrink tumors better than atezolizumab alone in people with advanced head and neck cancer that has come back or spread. The study enrolled 123 adults whose tumors have a specific protein (PD-L1). Researchers measured how many patients had their tumors shrink significantly. The goal is to find a more effective first treatment for this hard-to-treat cancer.

What this could mean

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

Active substance
Atezolizumab (Tecentriq) and tiragolumab
What this could lead to
If this combination works better than atezolizumab alone, it could offer a new first-line treatment option for people with advanced head and neck cancer.
What could go wrong
This is a phase 2 trial with only 123 participants, so results are preliminary. The combination may not improve outcomes significantly and could cause added side effects.

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

123 people

The number who actually took part.

Started

Mar 2021

Finished

Aug 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: * Histologically or cytologically confirmed recurrent/metastatic SCCHN involving the oropharynx, oral cavity, larynx, or hypopharynx, that is considered incurable by local therapies * Known results from human papillomavirus (HPV) status test for oropharyngeal carcinoma * No prior systemic therapy for metastatic and/or recurrent SCCHN * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * Tumor PD-L1 expression as determined by PD-L1 immunohistochemistry assay * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy \>=12 weeks Key Exclusion Criteria: * Disease suitable for local therapy with curative intent * Progressive or recurrent disease within 6 months of the last dose of curative intent systemic treatment for locally advanced SCCHN * Rapidly progressing disease in the opinion of the treating investigator * Grade \>=2 unresolved toxicity related to surgery or other prior therapies * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * History of leptomeningeal disease * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * History of additional malignancy other than SCCHN within 5 years prior to randomization * Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-TIGIT, anti-PD-L1, and anti-PD-1 therapeutic antibodies * Treatment with systemic immunostimulatory agents or systemic immunosuppressive medication * Pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

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.

Squamous cell carcinoma of head and neck

Contacts and locations

Locations

  • Anticancer Hospital Ag Savas

    Athens, 115 22, Greece

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asst Degli Spedali Civili Di Brescia

    Brescia, Lombardy, 25100, Italy

  • Attiko Hospital University of Athens

    Athens, 12462, Greece

  • Auckland City Hospital, Cancer and Blood Research

    Auckland, 1023, New Zealand

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Tuscany, 50134, Italy

  • Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont

    Kecskemét, 6000, Hungary

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • Beskidzkie Centrum Onkologii- Szpital Miejski

    Bielsko-Biala, 43-300, Poland

  • CHU Bordeaux

    Bordeaux, 33075, France

  • Centre Francois Baclesse

    Caen, 14076, France

  • Centre Leon Berard

    Lyon, 69373, France

  • Centrum Onkologii Ziemi Lubelskiej Im. ?W. Jana Z Dukli

    Lublin, 20-090, Poland

  • Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

    Lodz, 90-242, Poland

  • China Medical University Hospital

    Taichung, 404, Taiwan

  • Euromedical General Clinic of Thessaloniki

    Thessaloniki, 546 45, Greece

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice v Motole

    Prague, 150 06, Czechia

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133, Italy

  • Guys and St Thomas NHS Foundation Trust, Guys Hospital

    London, SE1 9RT, United Kingdom

  • Gy?r-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház

    Gy?r, 9024, Hungary

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Institut Catala d Oncologia Hospital Duran i Reynals

    Barcelona, 08908, Spain

  • Institut Curie

    Paris, 75231, France

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519, France

  • Institut régional du Cancer Montpellier

    Montpellier, 34298, France

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Masarykuv onkologicky ustav

    Brno, 656 53, Czechia

  • Moores Cancer Center at UC San Diego Health

    La Jolla, California, 92093, United States

  • National Taiwan University Hospital

    Zhongzheng Dist., 10048, Taiwan

  • Periph. University General Hospital of Heraklion Crete

    Heraklion, 711 10, Greece

  • Pécsi Tudományegyetem

    Pécs, 7623, Hungary

  • Ramathibodi Hospital

    Bangkok, 10400, Thailand

  • Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT, United Kingdom

  • SCRI Florida Cancer Specialists PAN

    Tallahassee, Florida, 32308, United States

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • Taipei Veterans General Hospital

    Taipei, 112201, Taiwan

  • Tennessee Oncology - Nashville

    Nashville, Tennessee, 37203, United States

  • UCLA

    Los Angeles, California, 90095, United States

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214, Poland

  • Velindre Cancer Centre

    Cardiff, CF14 2TL, United Kingdom

  • Washington University School of Medicine

    St Louis, Missouri, 63108, United States

More trials for these conditions

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