Neoplasms, Head and NeckPhase 2NCT06062420
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
A Phase 2 study testing Dostarlimab, Belrestotug and Nelistotug in people with Neoplasms, Head and Neck, run by GlaxoSmithKline at 108 sites in 20 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Head and Neck
- What is being tested?
- Dostarlimab, Belrestotug and Nelistotug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 108 sitesin 20 countries
- Study dates
- 14 Nov 2023to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
108 sites in 20 countries.
108 sites in 20 countries
Spain13 sites
GSK Investigational Site
Barcelona, 08023
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Barcelona, 08907
GSK Investigational Site
Jaén, 23007
GSK Investigational Site
Madrid, 28010
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Pozuelo de AlarcOn Madr, 28223
GSK Investigational Site
Salamanca, 37007
GSK Investigational Site
Santander, 39008
GSK Investigational Site
Valencia, 46009
GSK Investigational Site
Zaragoza, 50009
Italy11 sites
GSK Investigational Site
Bari, 70124
GSK Investigational Site
Bologna, 40139
GSK Investigational Site
Florence, 50134
GSK Investigational Site
Genova, 16132
GSK Investigational Site
Milan, 20133
GSK Investigational Site
Naples, 80131
GSK Investigational Site
Novara, 28100
GSK Investigational Site
Padova, 35128
GSK Investigational Site
Roma, 00144
GSK Investigational Site
Roma, 00168
GSK Investigational Site
Rozzano, MI, 20089
Romania11 sites
GSK Investigational Site
Brasov, 500283
GSK Investigational Site
Bucharest, 020142
GSK Investigational Site
Bucharest, 022328
GSK Investigational Site
Bucharest, 030171
GSK Investigational Site
Bucharest, 30463
GSK Investigational Site
Craiova, 200542
GSK Investigational Site
Floreşti, 407280
GSK Investigational Site
Iași, 700483
GSK Investigational Site
Oradea, 410469
GSK Investigational Site
Piteşti, 110283
GSK Investigational Site
Suceava, 720214
Argentina8 sites
GSK Investigational Site
Buenos Aires, C1426ABP
GSK Investigational Site
Capital Federal, C1181ACH
GSK Investigational Site
Ciudad Autonoma de Bueno, C1056ABI
GSK Investigational Site
Córdoba, 5000
GSK Investigational Site
Florida, B1602DQD
GSK Investigational Site
Mendoza, M5500AYB
GSK Investigational Site
San Juan, 5400
GSK Investigational Site
Santa Fe, 3000
Germany8 sites
GSK Investigational Site
Aachen, 52074
GSK Investigational Site
Berlin, 12203
GSK Investigational Site
Essen, North Rhine-Westphalia, 45122
GSK Investigational Site
Frankfurt am Main, Hesse, 60488
GSK Investigational Site
Giessen, 35392
GSK Investigational Site
Hamburg, 20246
GSK Investigational Site
Regensburg, 93053
GSK Investigational Site
Ulm, 89075
Japan7 sites
GSK Investigational Site
Aichi, 464-8681
GSK Investigational Site
Chiba, 277-8577
GSK Investigational Site
Hyōgo, 650-0017
GSK Investigational Site
Osaka, 541-8567
GSK Investigational Site
Saitama, 350-1298
GSK Investigational Site
Shizuoka, 411-8777
GSK Investigational Site
Tokyo, 104-0045
France6 sites
GSK Investigational Site
Bordeaux, 33075
GSK Investigational Site
Caen, 14075
GSK Investigational Site
Marseille, 13005
GSK Investigational Site
Paris, 75005
GSK Investigational Site
Rouen, 76038
GSK Investigational Site
Villejuif, 94805
Poland6 sites
GSK Investigational Site
Bielsko-Biala, 43-300
GSK Investigational Site
Katowice, 40-514
GSK Investigational Site
Krakow, 31-826
GSK Investigational Site
Przemyśl, 37-700
GSK Investigational Site
Siedlce, 08-110
GSK Investigational Site
Warsaw, 04-141
United States5 sites
GSK Investigational Site
Columbus, Ohio, 43210
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Milwaukee, Wisconsin, 53226
GSK Investigational Site
New Haven, Connecticut, 06511
GSK Investigational Site
St Louis, Missouri, 63110-1010
Canada5 sites
GSK Investigational Site
Calgary, Alberta, T2N 5G2
GSK Investigational Site
Edmonton, Alberta, T6G 1Z2
GSK Investigational Site
Montreal, Quebec, H3T 1E2
GSK Investigational Site
Toronto, Ontario, M4N 3M5
GSK Investigational Site
Toronto, Ontario, M5G 2M9
South Korea5 sites
GSK Investigational Site
Daegu, 42601
GSK Investigational Site
Seongnam-si Gyeonggi-do, 13620
GSK Investigational Site
Seoul, 03722
GSK Investigational Site
Seoul, 138-736
GSK Investigational Site
Suwon Kyunggi-do, 443-721
Portugal4 sites
GSK Investigational Site
Almada, 2801-951
GSK Investigational Site
Lisbon, 1649-035
GSK Investigational Site
Porto, 4099-001
GSK Investigational Site
Porto, 4200-072
Taiwan4 sites
GSK Investigational Site
Changhua, 500
GSK Investigational Site
Tainan, 704
GSK Investigational Site
Taipei, 10002
GSK Investigational Site
Taipei, 11217
Brazil3 sites
GSK Investigational Site
Santo André, 09060-650
GSK Investigational Site
São Paulo, 01221-020
GSK Investigational Site
São Paulo, 01246-000
Greece3 sites
GSK Investigational Site
Haidari - Athens, 12462
GSK Investigational Site
Marousi
GSK Investigational Site
Panórama, Central Macedonia, 552 36
Hungary3 sites
GSK Investigational Site
Győr, 9024
GSK Investigational Site
Kecskemét, 6000
GSK Investigational Site
Pécs, 7624
Turkey (Türkiye)3 sites
GSK Investigational Site
Ankara, 06100
GSK Investigational Site
Istanbul, 34662
GSK Investigational Site
Izmir, 35040
About this study
Official title: 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).
- Conditions
- Neoplasms, Head and Neck
- Being tested
- Dostarlimab, Belrestotug, Nelistotug, Remzistotug
- Keywords
- Dostarlimab, Belrestotug, Nelistotug, Remzistotug, PD-L1, HNSCC
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DostarlimabDrug
Dostarlimab will be administered.
BelrestotugDrug
Belrestotug will be administered.
NelistotugDrug
Nelistotug will be administered.
RemzistotugDrug
Remzistotug will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Dostarlimab Monotherapy | Experimental | Not described Receives: Drug: Dostarlimab |
| Sub study 1: Dostarlimab and Belrestotug | Experimental | Not described Receives: Drug: Dostarlimab; Drug: Belrestotug |
| Sub study 2: Dostarlimab and nelistotug | Experimental | Not described Receives: Drug: Dostarlimab; Drug: Nelistotug |
| Sub study 3: Dosarlimab and Belrestotug and nelistotug | Experimental | Not described Receives: Drug: Dostarlimab; Drug: Belrestotug; Drug: Nelistotug |
| Sub study 4: Dostarlimab and remzistotug | Experimental | Not described Receives: Drug: Dostarlimab; Drug: Remzistotug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy
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.
Measured: Up to approximately 24 months
Secondary outcomes (3)
Number of Participants with Treatment Emergent Adverse Events (AEs), treatment emergent Serious Adverse Events (SAE) and treatment emergent Adverse Events of Special Interest (AESI)
Measured: Up to approximately 24 months
Number of Participants with TEAEs leading to dose modifications or study intervention discontinuation
Measured: Up to approximately 24 months
Number of Participants with Clinically Significant Findings in Vital signs, Electrocardiogram (ECG), and Laboratory test parameters
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start14 Nov 2023
- Primary completion10 Sep 2026
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, Head and NeckStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- iTeos Therapeutics
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062420
- Sponsor's protocol ID
- 219885
- Other IDs
- 2023-503428-24, 2023
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06062420
- Acronym / sponsor ID
- 219885
- Conditions
- Neoplasms, Head and Neck
- Keywords
- Dostarlimab, Belrestotug, Nelistotug, Remzistotug, PD-L1, HNSCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 316 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- iTeos Therapeutics
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 10 Sep 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dostarlimab Monotherapy | Experimental | Drug: Dostarlimab |
| Sub study 1: Dostarlimab and Belrestotug | Experimental | Drug: Dostarlimab, Drug: Belrestotug |
| Sub study 2: Dostarlimab and nelistotug | Experimental | Drug: Dostarlimab, Drug: Nelistotug |
| Sub study 3: Dosarlimab and Belrestotug and nelistotug | Experimental | Drug: Dostarlimab, Drug: Belrestotug, Drug: Nelistotug |
| Sub study 4: Dostarlimab and remzistotug | Experimental | Drug: Dostarlimab, Drug: Remzistotug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DostarlimabDostarlimab will be administered. | Drug | Dostarlimab Monotherapy, Sub study 1: Dostarlimab and Belrestotug, Sub study 2: Dostarlimab and nelistotug, Sub study 3: Dosarlimab and Belrestotug and nelistotug, Sub study 4: Dostarlimab and remzistotug |
| BelrestotugBelrestotug will be administered. | Drug | Sub study 1: Dostarlimab and Belrestotug, Sub study 3: Dosarlimab and Belrestotug and nelistotug |
| NelistotugNelistotug will be administered. | Drug | Sub study 2: Dostarlimab and nelistotug, Sub study 3: Dosarlimab and Belrestotug and nelistotug |
| RemzistotugRemzistotug will be administered. | Drug | Sub study 4: Dostarlimab and remzistotug |
Primary outcome
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.
3 secondary outcomes
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
Number of Participants with TEAEs leading to dose modifications or study intervention discontinuation
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
108 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dostarlimab, Belrestotug and Nelistotug in people with Neoplasms, Head and Neck, run by GlaxoSmithKline at 108 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 108 sites in Spain, Italy, Romania, Argentina, Germany and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.