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ACTIVE NOT RECRUITING

NCT06062420

PHASE2

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

316

Start Date

2023-11-14

Completion Date

2027-12-31

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Neoplasms, Head and Neck

Interventions

DRUG

Dostarlimab

Dostarlimab will be administered.

DRUG

Belrestotug

Belrestotug will be administered.

DRUG

Nelistotug

Nelistotug will be administered.

DRUG

Remzistotug

Remzistotug will be administered.

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.)

Locations (108)

GSK Investigational Site

New Haven, Connecticut, United States

GSK Investigational Site

Iowa City, Iowa, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Columbus, Ohio, United States

GSK Investigational Site

Milwaukee, Wisconsin, United States

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Capital Federal, Argentina

GSK Investigational Site

Ciudad Autonoma de Bueno, Argentina

GSK Investigational Site

Córdoba, Argentina

GSK Investigational Site

Florida, Argentina

GSK Investigational Site

Mendoza, Argentina

GSK Investigational Site

San Juan, Argentina

GSK Investigational Site

Santa Fe, Argentina

GSK Investigational Site

Santo André, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

Calgary, Alberta, Canada

GSK Investigational Site

Edmonton, Alberta, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Herlev, Denmark

GSK Investigational Site

Turku, Finland

GSK Investigational Site

Bordeaux, France

GSK Investigational Site

Caen, France

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Marseille, France

GSK Investigational Site

Paris, France

GSK Investigational Site

Rouen, France

GSK Investigational Site

Villejuif, France

GSK Investigational Site

Aachen, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Essen, Germany

GSK Investigational Site

Frankfurt, Germany

GSK Investigational Site

Giessen, Germany

GSK Investigational Site

Hamburg, Germany

GSK Investigational Site

Regensburg, Germany

GSK Investigational Site

Ulm, Germany

GSK Investigational Site

Haidari - Athens, Greece

GSK Investigational Site

Marousi, Greece

GSK Investigational Site

Thessaloniki, Greece

GSK Investigational Site

Győr, Hungary

GSK Investigational Site

Kecskemét, Hungary

GSK Investigational Site

Pécs, Hungary

GSK Investigational Site

Bari, Italy

GSK Investigational Site

Bologna, Italy

GSK Investigational Site

Florence, Italy

GSK Investigational Site

Genova, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Naples, Italy

GSK Investigational Site

Novara, Italy

GSK Investigational Site

Padova, Italy

GSK Investigational Site

Roma, Italy

GSK Investigational Site

Roma, Italy

GSK Investigational Site

Rozzano MI, Italy

GSK Investigational Site

Aichi, Japan

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Hyōgo, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Saitama, Japan

GSK Investigational Site

Shizuoka, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Oslo, Norway

GSK Investigational Site

Bielsko-Biala, Poland

GSK Investigational Site

Katowice, Poland

GSK Investigational Site

Krakow, Poland

GSK Investigational Site

Przemyśl, Poland

GSK Investigational Site

Siedlce, Poland

GSK Investigational Site

Warsaw, Poland

GSK Investigational Site

Almada, Portugal

GSK Investigational Site

Lisbon, Portugal

GSK Investigational Site

Porto, Portugal

GSK Investigational Site

Porto, Portugal

GSK Investigational Site

Brasov, Romania

GSK Investigational Site

Bucharest, Romania

GSK Investigational Site

Bucharest, Romania

GSK Investigational Site

Bucharest, Romania

GSK Investigational Site

Bucharest, Romania

GSK Investigational Site

Craiova, Romania

GSK Investigational Site

Floreşti, Romania

GSK Investigational Site

Iași, Romania

GSK Investigational Site

Oradea, Romania

GSK Investigational Site

Piteşti, Romania

GSK Investigational Site

Suceava, Romania

GSK Investigational Site

Daegu, South Korea

GSK Investigational Site

Seongnam-si Gyeonggi-do, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Suwon Kyunggi-do, South Korea

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Jaén, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Pozuelo de AlarcOn Madr, Spain

GSK Investigational Site

Salamanca, Spain

GSK Investigational Site

Santander, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

Zaragoza, Spain

GSK Investigational Site

Changhua, Taiwan

GSK Investigational Site

Tainan, Taiwan

GSK Investigational Site

Taipei, Taiwan

GSK Investigational Site

Taipei, Taiwan

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Istanbul, Turkey (Türkiye)

GSK Investigational Site

Izmir, Turkey (Türkiye)

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (108)