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

NCT06062420 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2198852023-503428-24
• Study Type: interventional
• Target: 316
• Locations: 20 countries
• Sites: 108

Brief 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).

Conditions

Neoplasms, Head and Neck

Keywords

Dostarlimab; Belrestotug; Nelistotug; Remzistotug; PD-L1; HNSCC

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Up to approximately 24 months

• Number of Participants with TEAEs leading to dose modifications or study intervention discontinuation

  Up to approximately 24 months

• Number of Participants with Clinically Significant Findings in Vital signs, Electrocardiogram (ECG), and Laboratory test parameters

  Up to approximately 24 months

Study Arms (5)

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

Interventions

Dostarlimab DRUG

Dostarlimab will be administered.

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

Belrestotug DRUG

Belrestotug will be administered.

Sub study 1: Dostarlimab and Belrestotug; Sub study 3: Dosarlimab and Belrestotug and nelistotug

Nelistotug DRUG

Nelistotug will be administered.

Sub study 2: Dostarlimab and nelistotug; Sub study 3: Dosarlimab and Belrestotug and nelistotug

Remzistotug DRUG

Remzistotug will be administered.

Sub study 4: Dostarlimab and remzistotug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• GlaxoSmithKline: lead
• iTeos Therapeutics: collaborator

Study Sites (108)

GSK Investigational Site

New Haven, Connecticut, 06511, United States

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Iowa City, Iowa, 52242, United States

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St Louis, Missouri, 63021, United States

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Columbus, Ohio, 43210, United States

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Milwaukee, Wisconsin, 53226, United States

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Buenos Aires, C1426ABP, Argentina

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Capital Federal, C1181ACH, Argentina

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Ciudad Autonoma de Bueno, C1056ABI, Argentina

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Córdoba, 5000, Argentina

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Florida, B1602DQD, Argentina

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Mendoza, M5500AYB, Argentina

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San Juan, 5400, Argentina

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Santa Fe, 3000, Argentina

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Santo André, 09060-650, Brazil

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São Paulo, 01221-020, Brazil

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São Paulo, 01246-000, Brazil

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Calgary, Alberta, T2N 5G2, Canada

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Edmonton, Alberta, T6G 1Z2, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Herlev, Denmark

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Turku, 20520, Finland

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Bordeaux, 33075, France

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Caen, 14075, France

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Marseille, 13005, France

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Paris, 75005, France

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Rouen, 76038, France

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Villejuif, 94805, France

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Aachen, 52074, Germany

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Berlin, 12200, Germany

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Essen, 45122, Germany

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Frankfurt, 60488, Germany

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Giessen, 35392, Germany

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Hamburg, 20246, Germany

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Regensburg, 93053, Germany

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Ulm, 89075, Germany

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Haidari - Athens, 12462, Greece

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Marousi, Greece

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Thessaloniki, 55236, Greece

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Győr, 9024, Hungary

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Kecskemét, 6000, Hungary

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Pécs, 7624, Hungary

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Bari, 70124, Italy

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Bologna, 40139, Italy

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Florence, 50134, Italy

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Genova, 16132, Italy

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Milan, 20133, Italy

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Naples, 80131, Italy

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Novara, 28100, Italy

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Padova, 35128, Italy

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Roma, 00144, Italy

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Roma, 00168, Italy

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Rozzano MI, 20089, Italy

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Aichi, 464-8681, Japan

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Chiba, 277-8577, Japan

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Hyōgo, 650-0017, Japan

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Osaka, 541-8567, Japan

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Saitama, 350-1298, Japan

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Shizuoka, 411-8777, Japan

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Tokyo, 104-0045, Japan

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Oslo, 0379, Norway

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Bielsko-Biala, 43-300, Poland

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Katowice, 40-514, Poland

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Krakow, 31-826, Poland

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Przemyśl, 37-700, Poland

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Siedlce, 08-110, Poland

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Warsaw, 04-141, Poland

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Almada, 2801-951, Portugal

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Lisbon, 1649-035, Portugal

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Porto, 4099-001, Portugal

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Porto, 4200-072, Portugal

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Brasov, 500283, Romania

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Bucharest, 020142, Romania

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Bucharest, 022328, Romania

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Bucharest, 030171, Romania

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Bucharest, 30463, Romania

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Craiova, 200542, Romania

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Floreşti, 407280, Romania

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Iași, 700483, Romania

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Oradea, 410469, Romania

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Piteşti, 110283, Romania

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Suceava, 720214, Romania

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Daegu, 42601, South Korea

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Seongnam-si Gyeonggi-do, 13620, South Korea

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Seoul, 03722, South Korea

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Seoul, 138-736, South Korea

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Suwon Kyunggi-do, 443-721, South Korea

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Barcelona, 08023, Spain

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Barcelona, 08035, Spain

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Barcelona, 08907, Spain

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Jaén, 23007, Spain

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Madrid, 28010, Spain

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Madrid, 28034, Spain

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Madrid, 28040, Spain

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Madrid, 28041, Spain

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Pozuelo de AlarcOn Madr, 28223, Spain

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Salamanca, 37007, Spain

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Santander, 39008, Spain

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Valencia, 46009, Spain

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Zaragoza, 50009, Spain

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Changhua, 500, Taiwan

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Tainan, 704, Taiwan

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Taipei, 10002, Taiwan

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Taipei, 11217, Taiwan

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GSK Investigational Site

Ankara, 06100, Turkey (Türkiye)

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Istanbul, 34662, Turkey (Türkiye)

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Izmir, 35040, Turkey (Türkiye)

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MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

dostarlimab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 2, 2023
• Study Start: November 14, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

KR (5); FR (6); HU (3); PT (4); DK (1); BR (3); PL (6); NO (1); CA (5); IT (11); TU (3); JP (7); DE (8); US (5); TW (4); RO (11); AR (8); GR (3); ES (13); FI (1)