Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug cocktail aims to shrink tough head and neck tumors

NCT ID NCT06062420

Disease control Sponsor: GlaxoSmithKline 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether combining newer immunotherapy drugs (belrestotug, nelistotug, remzistotug) with the standard drug dostarlimab can shrink tumors better than dostarlimab alone in people with advanced head and neck cancer that has come back or spread. About 316 participants whose cancer has a specific protein (PD-L1) will receive one of the combinations or the standard drug. The main goal is to see how many people's tumors shrink significantly.

What this could mean

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

Active substance
Dostarlimab, Belrestotug, Nelistotug, Remzistotug (immunotherapy drugs)
What this could lead to
If successful, this could point toward more effective first-line treatment options for people with advanced head and neck cancer, potentially shrinking tumors better than current immunotherapy alone.
What could go wrong
This is a mid-stage trial with only 316 participants, so results may not apply to everyone. Immunotherapy can cause serious side effects like inflammation of organs, and the new combinations might not work better than the standard drug.

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

316 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

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: * Have histologically or cytologically-confirmed HNSCC that is R/M and is considered incurable by local therapies. A) Subjects must not have had prior systemic therapy administered in the R/M setting. Chemoradiation therapy which was completed more than 4 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed B) The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx C) Subjects may not have a primary tumor site of nasopharynx (any histology) * Has measurable (target) disease based on RECIST 1.1 as determined by the investigator. * Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 * Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of R/M HNSCC. A fresh tumor tissue sample obtained within 90 days of screening is highly preferred, If fresh biopsy is not possible, an archival tumor specimen is acceptable unless it was obtained prior to administration of chemoradiation for the treatment of a participant's tumor. Needle or excisional biopsies or resected tissue is required. Cytological specimens such as fine needle aspirates, bone marrow samples, or cell blocks are not acceptable. Bone specimen is not acceptable. * Has tumor Programmed death ligand 1 (PD-L1) expression * If the primary tumor site is oropharyngeal carcinoma, the participant must have Human papillomavirus (HPV) results Exclusion Criteria: * Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting Programmed death protein 1 (PD-1), PD-L1, Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), T cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine based inhibitory motif domains (TIGIT), Cluster of differentiation (CD) 96, or other immune checkpoint pathways. * Participants with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, esophageal, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period. * Have active tumor bleeding or a high risk of bleeding (examples include but are not limited to radiographic evidence of major blood vessel invasion/infiltration or tumor demonstrates \>90 degree abutment or encasement of a major vessel \[carotid, jugular, bronchial artery\] and/or exhibits other high-risk features such as arteriovenous fistula). * Has PD within 4 months of completion of curatively intended treatment for locoregionally advanced HNSCC * Participants with any carcinomatous meningitis or leptomeningeal spread and those with uncontrolled or symptomatic Central Nervous System (CNS) metastases * Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years. (Stable, medically managed autoimmune endocrinopathies are acceptable if participant otherwise meets entry criteria.)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Neoplasms, head and neck are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

head and neck neoplasm 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.

Neoplasms, head and neck

Contacts and locations

Locations

  • GSK Investigational Site

    New Haven, Connecticut, 06511, United States

  • GSK Investigational Site

    Iowa City, Iowa, 52242, United States

  • GSK Investigational Site

    St Louis, Missouri, 63021, United States

  • GSK Investigational Site

    Columbus, Ohio, 43210, United States

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53226, United States

  • GSK Investigational Site

    Buenos Aires, C1426ABP, Argentina

  • GSK Investigational Site

    Capital Federal, C1181ACH, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, C1056ABI, Argentina

  • GSK Investigational Site

    Córdoba, 5000, Argentina

  • GSK Investigational Site

    Florida, B1602DQD, Argentina

  • GSK Investigational Site

    Mendoza, M5500AYB, Argentina

  • GSK Investigational Site

    San Juan, 5400, Argentina

  • GSK Investigational Site

    Santa Fe, 3000, Argentina

  • GSK Investigational Site

    Santo André, 09060-650, Brazil

  • GSK Investigational Site

    São Paulo, 01221-020, Brazil

  • GSK Investigational Site

    São Paulo, 01246-000, Brazil

  • GSK Investigational Site

    Calgary, Alberta, T2N 5G2, Canada

  • GSK Investigational Site

    Edmonton, Alberta, T6G 1Z2, Canada

  • GSK Investigational Site

    Toronto, Ontario, M4N 3M5, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9, Canada

  • GSK Investigational Site

    Montreal, Quebec, H3T 1E2, Canada

  • GSK Investigational Site

    Herlev, Denmark

  • GSK Investigational Site

    Turku, 20520, Finland

  • GSK Investigational Site

    Bordeaux, 33075, France

  • GSK Investigational Site

    Caen, 14075, France

  • GSK Investigational Site

    Marseille, 13005, France

  • GSK Investigational Site

    Paris, 75005, France

  • GSK Investigational Site

    Rouen, 76038, France

  • GSK Investigational Site

    Villejuif, 94805, France

  • GSK Investigational Site

    Aachen, 52074, Germany

  • GSK Investigational Site

    Berlin, 12200, Germany

  • GSK Investigational Site

    Essen, 45122, Germany

  • GSK Investigational Site

    Frankfurt, 60488, Germany

  • GSK Investigational Site

    Giessen, 35392, Germany

  • GSK Investigational Site

    Hamburg, 20246, Germany

  • GSK Investigational Site

    Regensburg, 93053, Germany

  • GSK Investigational Site

    Ulm, 89075, Germany

  • GSK Investigational Site

    Haidari - Athens, 12462, Greece

  • GSK Investigational Site

    Marousi, Greece

  • GSK Investigational Site

    Thessaloniki, 55236, Greece

  • GSK Investigational Site

    Győr, 9024, Hungary

  • GSK Investigational Site

    Kecskemét, 6000, Hungary

  • GSK Investigational Site

    Pécs, 7624, Hungary

  • GSK Investigational Site

    Bari, 70124, Italy

  • GSK Investigational Site

    Bologna, 40139, Italy

  • GSK Investigational Site

    Florence, 50134, Italy

  • GSK Investigational Site

    Genova, 16132, Italy

  • GSK Investigational Site

    Milan, 20133, Italy

  • GSK Investigational Site

    Naples, 80131, Italy

  • GSK Investigational Site

    Novara, 28100, Italy

  • GSK Investigational Site

    Padova, 35128, Italy

  • GSK Investigational Site

    Roma, 00144, Italy

  • GSK Investigational Site

    Roma, 00168, Italy

  • GSK Investigational Site

    Rozzano MI, 20089, Italy

  • GSK Investigational Site

    Aichi, 464-8681, Japan

  • GSK Investigational Site

    Chiba, 277-8577, Japan

  • GSK Investigational Site

    Hyōgo, 650-0017, Japan

  • GSK Investigational Site

    Osaka, 541-8567, Japan

  • GSK Investigational Site

    Saitama, 350-1298, Japan

  • GSK Investigational Site

    Shizuoka, 411-8777, Japan

  • GSK Investigational Site

    Tokyo, 104-0045, Japan

  • GSK Investigational Site

    Oslo, 0379, Norway

  • GSK Investigational Site

    Bielsko-Biala, 43-300, Poland

  • GSK Investigational Site

    Katowice, 40-514, Poland

  • GSK Investigational Site

    Krakow, 31-826, Poland

  • GSK Investigational Site

    Przemyśl, 37-700, Poland

  • GSK Investigational Site

    Siedlce, 08-110, Poland

  • GSK Investigational Site

    Warsaw, 04-141, Poland

  • GSK Investigational Site

    Almada, 2801-951, Portugal

  • GSK Investigational Site

    Lisbon, 1649-035, Portugal

  • GSK Investigational Site

    Porto, 4099-001, Portugal

  • GSK Investigational Site

    Porto, 4200-072, Portugal

  • GSK Investigational Site

    Brasov, 500283, Romania

  • GSK Investigational Site

    Bucharest, 020142, Romania

  • GSK Investigational Site

    Bucharest, 022328, Romania

  • GSK Investigational Site

    Bucharest, 030171, Romania

  • GSK Investigational Site

    Bucharest, 30463, Romania

  • GSK Investigational Site

    Craiova, 200542, Romania

  • GSK Investigational Site

    Floreşti, 407280, Romania

  • GSK Investigational Site

    Iași, 700483, Romania

  • GSK Investigational Site

    Oradea, 410469, Romania

  • GSK Investigational Site

    Piteşti, 110283, Romania

  • GSK Investigational Site

    Suceava, 720214, Romania

  • GSK Investigational Site

    Daegu, 42601, South Korea

  • GSK Investigational Site

    Seongnam-si Gyeonggi-do, 13620, South Korea

  • GSK Investigational Site

    Seoul, 03722, South Korea

  • GSK Investigational Site

    Seoul, 138-736, South Korea

  • GSK Investigational Site

    Suwon Kyunggi-do, 443-721, South Korea

  • GSK Investigational Site

    Barcelona, 08023, Spain

  • GSK Investigational Site

    Barcelona, 08035, Spain

  • GSK Investigational Site

    Barcelona, 08907, Spain

  • GSK Investigational Site

    Jaén, 23007, Spain

  • GSK Investigational Site

    Madrid, 28010, Spain

  • GSK Investigational Site

    Madrid, 28034, Spain

  • GSK Investigational Site

    Madrid, 28040, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Pozuelo de AlarcOn Madr, 28223, Spain

  • GSK Investigational Site

    Salamanca, 37007, Spain

  • GSK Investigational Site

    Santander, 39008, Spain

  • GSK Investigational Site

    Valencia, 46009, Spain

  • GSK Investigational Site

    Zaragoza, 50009, Spain

  • GSK Investigational Site

    Changhua, 500, Taiwan

  • GSK Investigational Site

    Tainan, 704, Taiwan

  • GSK Investigational Site

    Taipei, 10002, Taiwan

  • GSK Investigational Site

    Taipei, 11217, Taiwan

  • GSK Investigational Site

    Ankara, 06100, Turkey (Türkiye)

  • GSK Investigational Site

    Istanbul, 34662, Turkey (Türkiye)

  • GSK Investigational Site

    Izmir, 35040, Turkey (Türkiye)

More trials for these conditions

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