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

May 21, 2026 updated by: GlaxoSmithKline

A Phase 2, Randomized, Open-label, Platform Study Using a Master Protocol to Evaluate Novel Immunotherapy Combinations as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

316

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • GSK Investigational Site
      • Capital Federal, Argentina, C1181ACH
        • GSK Investigational Site
      • Ciudad Autonoma de Bueno, Argentina, C1056ABI
        • GSK Investigational Site
      • Córdoba, Argentina, 5000
        • GSK Investigational Site
      • Florida, Argentina, B1602DQD
        • GSK Investigational Site
      • Mendoza, Argentina, M5500AYB
        • GSK Investigational Site
      • San Juan, Argentina, 5400
        • GSK Investigational Site
      • Santa Fe, Argentina, 3000
        • GSK Investigational Site
  • Brazil
      • Santo André, Brazil, 09060-650
        • GSK Investigational Site
      • São Paulo, Brazil, 01246-000
        • GSK Investigational Site
      • São Paulo, Brazil, 01221-020
        • GSK Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • GSK Investigational Site
      • Edmonton, Alberta, Canada, T6G 1Z2
        • GSK Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G 2M9
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • GSK Investigational Site
  • Denmark
      • Herlev, Denmark
        • GSK Investigational Site
  • Finland
      • Turku, Finland, 20520
        • GSK Investigational Site
  • France
      • Bordeaux, France, 33075
        • GSK Investigational Site
      • Caen, France, 14075
        • GSK Investigational Site
      • Marseille, France, 13005
        • GSK Investigational Site
      • Paris, France, 75005
        • GSK Investigational Site
      • Rouen, France, 76038
        • GSK Investigational Site
      • Villejuif, France, 94805
        • GSK Investigational Site
  • Germany
      • Aachen, Germany, 52074
        • GSK Investigational Site
      • Berlin, Germany, 12200
        • GSK Investigational Site
      • Essen, Germany, 45122
        • GSK Investigational Site
      • Frankfurt, Germany, 60488
        • GSK Investigational Site
      • Giessen, Germany, 35392
        • GSK Investigational Site
      • Hamburg, Germany, 20246
        • GSK Investigational Site
      • Regensburg, Germany, 93053
        • GSK Investigational Site
      • Ulm, Germany, 89075
        • GSK Investigational Site
  • Greece
      • Haidari - Athens, Greece, 12462
        • GSK Investigational Site
      • Marousi, Greece
        • GSK Investigational Site
      • Thessaloniki, Greece, 55236
        • GSK Investigational Site
  • Hungary
      • Győr, Hungary, 9024
        • GSK Investigational Site
      • Kecskemét, Hungary, 6000
        • GSK Investigational Site
      • Pécs, Hungary, 7624
        • GSK Investigational Site
  • Italy
      • Bari, Italy, 70124
        • GSK Investigational Site
      • Bologna, Italy, 40139
        • GSK Investigational Site
      • Florence, Italy, 50134
        • GSK Investigational Site
      • Genova, Italy, 16132
        • GSK Investigational Site
      • Milan, Italy, 20133
        • GSK Investigational Site
      • Naples, Italy, 80131
        • GSK Investigational Site
      • Novara, Italy, 28100
        • GSK Investigational Site
      • Padova, Italy, 35128
        • GSK Investigational Site
      • Roma, Italy, 00168
        • GSK Investigational Site
      • Roma, Italy, 00144
        • GSK Investigational Site
      • Rozzano MI, Italy, 20089
        • GSK Investigational Site
  • Japan
      • Aichi, Japan, 464-8681
        • GSK Investigational Site
      • Chiba, Japan, 277-8577
        • GSK Investigational Site
      • Hyōgo, Japan, 650-0017
        • GSK Investigational Site
      • Osaka, Japan, 541-8567
        • GSK Investigational Site
      • Saitama, Japan, 350-1298
        • GSK Investigational Site
      • Shizuoka, Japan, 411-8777
        • GSK Investigational Site
      • Tokyo, Japan, 104-0045
        • GSK Investigational Site
  • Norway
      • Oslo, Norway, 0379
        • GSK Investigational Site
  • Poland
      • Bielsko-Biala, Poland, 43-300
        • GSK Investigational Site
      • Katowice, Poland, 40-514
        • GSK Investigational Site
      • Krakow, Poland, 31-826
        • GSK Investigational Site
      • Przemyśl, Poland, 37-700
        • GSK Investigational Site
      • Siedlce, Poland, 08-110
        • GSK Investigational Site
      • Warsaw, Poland, 04-141
        • GSK Investigational Site
  • Portugal
      • Almada, Portugal, 2801-951
        • GSK Investigational Site
      • Lisbon, Portugal, 1649-035
        • GSK Investigational Site
      • Porto, Portugal, 4099-001
        • GSK Investigational Site
      • Porto, Portugal, 4200-072
        • GSK Investigational Site
  • Romania
      • Brasov, Romania, 500283
        • GSK Investigational Site
      • Bucharest, Romania, 020142
        • GSK Investigational Site
      • Bucharest, Romania, 022328
        • GSK Investigational Site
      • Bucharest, Romania, 030171
        • GSK Investigational Site
      • Bucharest, Romania, 30463
        • GSK Investigational Site
      • Craiova, Romania, 200542
        • GSK Investigational Site
      • Floreşti, Romania, 407280
        • GSK Investigational Site
      • Iași, Romania, 700483
        • GSK Investigational Site
      • Oradea, Romania, 410469
        • GSK Investigational Site
      • Piteşti, Romania, 110283
        • GSK Investigational Site
      • Suceava, Romania, 720214
        • GSK Investigational Site
  • South Korea
      • Daegu, South Korea, 42601
        • GSK Investigational Site
      • Seongnam-si Gyeonggi-do, South Korea, 13620
        • GSK Investigational Site
      • Seoul, South Korea, 138-736
        • GSK Investigational Site
      • Seoul, South Korea, 03722
        • GSK Investigational Site
      • Suwon Kyunggi-do, South Korea, 443-721
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Barcelona, Spain, 08907
        • GSK Investigational Site
      • Barcelona, Spain, 08023
        • GSK Investigational Site
      • Jaén, Spain, 23007
        • GSK Investigational Site
      • Madrid, Spain, 28041
        • GSK Investigational Site
      • Madrid, Spain, 28040
        • GSK Investigational Site
      • Madrid, Spain, 28034
        • GSK Investigational Site
      • Madrid, Spain, 28010
        • GSK Investigational Site
      • Pozuelo de AlarcOn Madr, Spain, 28223
        • GSK Investigational Site
      • Salamanca, Spain, 37007
        • GSK Investigational Site
      • Santander, Spain, 39008
        • GSK Investigational Site
      • Valencia, Spain, 46009
        • GSK Investigational Site
      • Zaragoza, Spain, 50009
        • GSK Investigational Site
  • Taiwan
      • Changhua, Taiwan, 500
        • GSK Investigational Site
      • Tainan, Taiwan, 704
        • GSK Investigational Site
      • Taipei, Taiwan, 11217
        • GSK Investigational Site
      • Taipei, Taiwan, 10002
        • GSK Investigational Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • GSK Investigational Site
      • Istanbul, Turkey (Türkiye), 34662
        • GSK Investigational Site
      • Izmir, Turkey (Türkiye), 35040
        • GSK Investigational Site
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • GSK Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • GSK Investigational Site
    • Missouri
      • St Louis, Missouri, United States, 63021
        • GSK Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dostarlimab Monotherapy
Drug: Dostarlimab
Dostarlimab will be administered.
Experimental: Sub study 1: Dostarlimab and Belrestotug
Drug: Dostarlimab
Dostarlimab will be administered.
Drug: Belrestotug
Belrestotug will be administered.
Experimental: Sub study 2: Dostarlimab and nelistotug
Drug: Dostarlimab
Dostarlimab will be administered.
Drug: Nelistotug
Nelistotug will be administered.
Experimental: Sub study 3: Dosarlimab and Belrestotug and nelistotug
Drug: Dostarlimab
Dostarlimab will be administered.
Drug: Belrestotug
Belrestotug will be administered.
Drug: Nelistotug
Nelistotug will be administered.
Experimental: Sub study 4: Dostarlimab and remzistotug
Drug: Dostarlimab
Dostarlimab will be administered.
Drug: Remzistotug
Remzistotug will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy
Time Frame: Up to approximately 24 months
Confirmed ORR is defined as the percentage of participants achieving confirmed Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment.
Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with TEAEs leading to dose modifications or study intervention discontinuation
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Number of Participants with Clinically Significant Findings in Vital signs, Electrocardiogram (ECG), and Laboratory test parameters
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Number of Participants with Treatment Emergent Adverse Events (AEs), treatment emergent Serious Adverse Events (SAE) and treatment emergent Adverse Events of Special Interest (AESI)
Time Frame: Up to approximately 24 months
Up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

iTeos Therapeutics

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

September 29, 2023

First Posted (Actual)

October 2, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 219885
  • 2023-503428-24 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neoplasms, Head and Neck

Clinical Trials on Dostarlimab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe