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

Last updated: November 22, 2024
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

2

Condition

Head And Neck Cancer

Lung Cancer

Treatment

GSK4381562

Dostarlimab

Nelistotug

Clinical Study ID

NCT06062420
219885
2023-503428-24-00
2023-503428-24
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have histologically or cytologically-confirmed HNSCC that is R/M and is consideredincurable by local therapies. A) Subjects must not have had prior systemic therapyadministered in the R/M setting. Chemoradiation therapy which was completed morethan 4 months prior to signing consent if given as part of multimodal treatment forlocally advanced disease is allowed B) The eligible primary tumor locations areoropharynx, oral cavity, hypopharynx, and larynx C) Subjects may not have a primarytumor site of nasopharynx (any histology)

  • Has measurable (target) disease based on RECIST 1.1 as determined by theinvestigator.

  • 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 initialdiagnosis of R/M HNSCC. A fresh tumor tissue sample obtained within 90 days ofscreening is highly preferred, If fresh biopsy is not possible, an archival tumorspecimen is acceptable unless it was obtained prior to administration ofchemoradiation for the treatment of a participant's tumour. Needle or excisionalbiopsies or resected tissue is required. Cytological specimens such as fine needleaspirates, bone marrow samples, or cell blocks are not acceptable. Bone specimen isnot acceptable.

  • Has tumor Programmed death ligand 1 (PD-L1) expression

  • If the primary tumor site is oropharyngeal carcinoma, the participant must haveHuman papillomavirus (HPV) results

Exclusion

Exclusion Criteria:

  • Has received prior therapy with any immune checkpoint inhibitors, includingantibodies or drugs targeting Programmed death protein 1 (PD-1), PD-L1, CytotoxicT-lymphocyte-associated protein 4 (CTLA-4), T cell immunoreceptor withimmunoglobulin 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 thefollowing in situ cancers: bladder, gastric, esophageal, colon, endometrial,cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved atleast 2 years prior to study entry AND no additional therapy is required during thestudy period.

  • Have active tumor bleeding or a high risk of bleeding (examples include but are notlimited to radiographic evidence of major blood vessel invasion/infiltration ortumor demonstrates >90 degree abutment or encasement of a major vessel [carotid,jugular, bronchial artery] and/or exhibits other high-risk features such asarteriovenous fistula).

  • Has PD within 4 months of completion of curatively intended treatment forlocoregionally advanced HNSCC

  • Participants with any carcinomatous meningitis or leptomeningeal spread and thosewith uncontrolled or symptomatic Central Nervous System (CNS) metastases

  • Active autoimmune disease that has required systemic disease-modifying orimmunosuppressive treatment within the last 2 years. (Stable, medically managedautoimmune endocrinopathies are acceptable if participant otherwise meets entrycriteria.)

Study Design

Total Participants: 360
Treatment Group(s): 5
Primary Treatment: GSK4381562
Phase: 2
Study Start date:
November 14, 2023
Estimated Completion Date:
May 14, 2027

Connect with a study center

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1181ACH
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Buenos Aires, C1426ABP
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Capital Federal, C1181ACH
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Ciudad AutOnoma De Bueno, C1417DTN
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Ciudad AutOnoma de Buenos Aires, C1426ABP
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autonoma De Bueno, C1056ABI
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Ciudad Autónoma de Buenos Aires, C1417DTN
    Argentina

    Site Not Available

  • GSK Investigational Site

    Cordoba, 5000
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Florida, B1602DQD
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Mendoza, M5500AYB
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    San Juan, 5400
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Santa Fe, 3000
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    SAo Paulo, 01246-000
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Santo Andre, 09060-650
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    São Paulo, 01221-020
    Brazil

    Site Not Available

  • GSK Investigational Site

    Calgary, Alberta T3N 4N1
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Edmonton, Alberta T6G 1Z2
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Herlev,
    Denmark

    Active - Recruiting

  • GSK Investigational Site

    Turku, 20520
    Finland

    Active - Recruiting

  • GSK Investigational Site

    Bordeaux, 33075
    France

    Active - Recruiting

  • GSK Investigational Site

    Bordeaux Cedex, 33075
    France

    Site Not Available

  • GSK Investigational Site

    Caen Cedex 5, 14075
    France

    Active - Recruiting

  • GSK Investigational Site

    Marseille, 13005
    France

    Site Not Available

  • GSK Investigational Site

    Marseille cedex 5, 13005
    France

    Active - Recruiting

  • GSK Investigational Site

    Paris, 75005
    France

    Active - Recruiting

  • GSK Investigational Site

    Rouen, 76038
    France

    Site Not Available

  • GSK Investigational Site

    Rouen Cedex 1, 76038
    France

    Active - Recruiting

  • GSK Investigational Site

    Saint Herblain, 44805
    France

    Site Not Available

  • GSK Investigational Site

    Villejuif Cedex, 94805
    France

    Active - Recruiting

  • GSK Investigational Site

    Aachen, 52074
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Berlin, 12200
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Essen, 45122
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Frankfurt, 60488
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Giessen, 35392
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Hamburg, 20246
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Leipzig, 04103
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Regensburg, 93053
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Ulm, 89075
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Athens,
    Greece

    Site Not Available

  • GSK Investigational Site

    Haidari - Athens, 12462
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Haidari, Athens, 12462
    Greece

    Site Not Available

  • GSK Investigational Site

    Marousi,
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Thessaloniki, 54622
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Gyor, 9024
    Hungary

    Active - Recruiting

  • GSK Investigational Site

    KecskemEt, 6000
    Hungary

    Active - Recruiting

  • GSK Investigational Site

    Kecskemét, 6000
    Hungary

    Site Not Available

  • GSK Investigational Site

    Nyiregyhaza, 4400
    Hungary

    Active - Recruiting

  • GSK Investigational Site

    Nyíregyháza, 4400
    Hungary

    Site Not Available

  • GSK Investigational Site

    PEcs, 7624
    Hungary

    Active - Recruiting

  • GSK Investigational Site

    Pécs, 7624
    Hungary

    Site Not Available

  • GSK Investigational Site

    Szolnok, 5000
    Hungary

    Active - Recruiting

  • GSK Investigational Site

    Rozzano (MI), Lombardia 20089
    Italy

    Site Not Available

  • GSK Investigational Site

    Bari, 70124
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Bologna, 40139
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Firenze, 50134
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Genova, 16132
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Milano, 20133
    Italy

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  • GSK Investigational Site

    Napoli, 80131
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Novara, 28100
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Padova, 35128
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Roma, 00144
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Rozzano MI, 20089
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Aichi, 464-8681
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Chiba, 277-8577
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Hyogo, 650-0017
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Osaka, 541-8567
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Saitama, 350-1298
    Japan

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  • GSK Investigational Site

    Shizuoka, 411-8777
    Japan

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  • GSK Investigational Site

    Tokyo, 104-0045
    Japan

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  • GSK Investigational Site

    Daegu, 42601
    Korea, Republic of

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  • GSK Investigational Site

    Daegu-si, 42601
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Seongnam-si Gyeonggi-do, 13620
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Seongnam-si, Gyeonggi-do, 13620
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Suwon Kyunggi-do, 443-721
    Korea, Republic of

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  • GSK Investigational Site

    Oslo, 0379
    Norway

    Active - Recruiting

  • GSK Investigational Site

    Bielsko-Biala, 43-300
    Poland

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  • GSK Investigational Site

    Gliwice, 44-102
    Poland

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  • GSK Investigational Site

    Katowice, 40-514
    Poland

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  • GSK Investigational Site

    Koszalin, 75-581
    Poland

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  • GSK Investigational Site

    Krakow, 31-826
    Poland

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  • GSK Investigational Site

    Poznan, 60-569
    Poland

    Site Not Available

  • GSK Investigational Site

    Przemysl, 37-700
    Poland

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  • GSK Investigational Site

    Siedlce, 08-110
    Poland

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  • GSK Investigational Site

    Warszawa, 04-141
    Poland

    Active - Recruiting

  • GSK Investigational Site

    Almada, 2801-951
    Portugal

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  • GSK Investigational Site

    Lisboa, 1649-035
    Portugal

    Active - Recruiting

  • GSK Investigational Site

    Porto, 4099-001
    Portugal

    Active - Recruiting

  • GSK Investigational Site

    Brasov, 500283
    Romania

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  • GSK Investigational Site

    Bucharest, 030171
    Romania

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  • GSK Investigational Site

    Bucuresti, 013823
    Romania

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  • GSK Investigational Site

    Craiova, 200542
    Romania

    Active - Recruiting

  • GSK Investigational Site

    Floresti, 407280
    Romania

    Active - Recruiting

  • GSK Investigational Site

    Iasi, 700483
    Romania

    Active - Recruiting

  • GSK Investigational Site

    Oradea, 410469
    Romania

    Active - Recruiting

  • GSK Investigational Site

    Pitesti, 110283
    Romania

    Active - Recruiting

  • GSK Investigational Site

    Suceava, 720214
    Romania

    Active - Recruiting

  • GSK Investigational Site

    Barcelona, 08023
    Spain

    Active - Recruiting

  • GSK Investigational Site

    JaEn, 23007
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Jaén, 23007
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28040
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Pozuelo De AlarcOn Madr, 28223
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Pozuelo De Alarcón/Madrid, 28223
    Spain

    Site Not Available

  • GSK Investigational Site

    Salamanca, 37007
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Santander, 39008
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Valencia, 46009
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Zaragoza, 50009
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Stockholm, SE-171 76
    Sweden

    Site Not Available

  • GSK Investigational Site

    Uppsala, SE- 75 185
    Sweden

    Site Not Available

  • GSK Investigational Site

    Changhua, 500
    Taiwan

    Active - Recruiting

  • GSK Investigational Site

    Tainan, 704
    Taiwan

    Active - Recruiting

  • GSK Investigational Site

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • GSK Investigational Site

    Taipei City, 11217
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Ankara, 06100
    Turkey

    Active - Recruiting

  • GSK Investigational Site

    Antalya, 07020
    Turkey

    Active - Recruiting

  • GSK Investigational Site

    Istanbul, 34662
    Turkey

    Active - Recruiting

  • GSK Investigational Site

    Izmir, 35040
    Turkey

    Active - Recruiting

  • GSK Investigational Site

    New Haven, Connecticut 06511
    United States

    Active - Recruiting

  • GSK Investigational Site

    Columbus, Georgia 43210-1240
    United States

    Active - Recruiting

  • GSK Investigational Site

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • GSK Investigational Site

    Iowa City, Iowa 52242-1009
    United States

    Active - Recruiting

  • GSK Investigational Site

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • GSK Investigational Site

    Saint Louis, Missouri 63021
    United States

    Active - Recruiting

  • GSK Investigational Site

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • GSK Investigational Site

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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