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

June 23, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
316

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
iTeos Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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