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A Platform Study of Novel Imm...

A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck- GALAXIES H&N-202

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-14

Study Completion Date

2027-07-22

Brief Summary

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The primary purpose of the study is to evaluate the antitumor activity and safety of novel immunotherapy combinations compared with dostarlimab in participants with Programmed death ligand 1 (PD-L1) positive Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC).

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Detailed Description

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Conditions

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Neoplasms, Head and Neck

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dostarlimab Monotherapy

Group Type EXPERIMENTAL

Dostarlimab

Intervention Type DRUG

Dostarlimab will be administered.

Sub study 1: Dostarlimab and Belrestotug

Group Type EXPERIMENTAL

Dostarlimab

Intervention Type DRUG

Dostarlimab will be administered.

Belrestotug

Intervention Type DRUG

Belrestotug will be administered.

Sub study 2: Dostarlimab and nelistotug

Group Type EXPERIMENTAL

Dostarlimab

Intervention Type DRUG

Dostarlimab will be administered.

Nelistotug

Intervention Type DRUG

Nelistotug will be administered.

Sub study 3: Dosarlimab and Belrestotug and nelistotug

Group Type EXPERIMENTAL

Dostarlimab

Intervention Type DRUG

Dostarlimab will be administered.

Belrestotug

Intervention Type DRUG

Belrestotug will be administered.

Nelistotug

Intervention Type DRUG

Nelistotug will be administered.

Sub study 4: Dostarlimab and remzistotug

Group Type EXPERIMENTAL

Dostarlimab

Intervention Type DRUG

Dostarlimab will be administered.

Remzistotug

Intervention Type DRUG

Remzistotug will be administered.

Interventions

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Dostarlimab

Dostarlimab will be administered.

Intervention Type DRUG

Belrestotug

Belrestotug will be administered.

Intervention Type DRUG

Nelistotug

Nelistotug will be administered.

Intervention Type DRUG

Remzistotug

Remzistotug will be administered.

Intervention Type DRUG

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

New Haven, Connecticut, United States

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Iowa City, Iowa, United States

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St Louis, Missouri, United States

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Columbus, Ohio, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, , Argentina

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Capital Federal, , Argentina

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Ciudad Autonoma de Bueno, , Argentina

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Córdoba, , Argentina

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Florida, , Argentina

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Mendoza, , Argentina

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San Juan, , Argentina

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Santa Fe, , Argentina

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Santo André, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Herlev, , Denmark

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Turku, , Finland

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Bordeaux, , France

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Caen, , France

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Marseille, , France

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Paris, , France

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Rouen, , France

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Villejuif, , France

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Aachen, , Germany

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Berlin, , Germany

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Essen, , Germany

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Frankfurt, , Germany

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Giessen, , Germany

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Hamburg, , Germany

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Leipzig, , Germany

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Regensburg, , Germany

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Ulm, , Germany

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Haidari - Athens, , Greece

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Marousi, , Greece

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Thessaloniki, , Greece

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Győr, , Hungary

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Kecskemét, , Hungary

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Pécs, , Hungary

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Bari, , Italy

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Bologna, , Italy

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Florence, , Italy

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Genova, , Italy

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Milan, , Italy

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Napoli, , Italy

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Novara, , Italy

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Padua, , Italy

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Roma, , Italy

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Roma, , Italy

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Rozzano MI, , Italy

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Aichi, , Japan

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Chiba, , Japan

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Hyōgo, , Japan

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Osaka, , Japan

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Saitama, , Japan

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Shizuoka, , Japan

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Tokyo, , Japan

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Oslo, , Norway

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Bielsko-Biala, , Poland

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Gliwice, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Przemyśl, , Poland

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Siedlce, , Poland

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Warsaw, , Poland

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Almada, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Porto, , Portugal

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Brasov, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Craiova, , Romania

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Floreşti, , Romania

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Iași, , Romania

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Oradea, , Romania

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Piteşti, , Romania

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Suceava, , Romania

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Daegu, , South Korea

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Seongnam-si Gyeonggi-do, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Suwon Kyunggi-do, , South Korea

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Jaén, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Pozuelo de AlarcOn Madr, , Spain

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Salamanca, , Spain

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Santander, , Spain

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Valencia, , Spain

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Zaragoza, , Spain

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Changhua, , Taiwan

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Tainan, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Countries

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United States Argentina Brazil Canada Denmark Finland France Germany Greece Hungary Italy Japan Norway Poland Portugal Romania South Korea Spain Taiwan Turkey (Türkiye)