> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-platform-study-of-novel-immunotherapy-combinations-as-f887453f-7656-4251-ba87-8be3fcd752b0 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) Participants 316 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) Start date 2023-11-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) Number of sites 108 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) ## Dates **Completion date** 2027-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **First posted** 2023-10-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **Registry last updated** 2026-06-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **Primary completion date** 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **Start date** 2023-11-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) ## Size and sites **Actual participants** 316 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **Participants** 316 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **Number of sites** 108 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) ## Identifiers **Registry ID** NCT06062420 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **ClinicalTrials.gov ID** NCT06062420 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) ## Outcomes ### Primary outcomes 1. Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy Timeframe: 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. ### Secondary outcomes 1. Number of Participants with Treatment Emergent Adverse Events (AEs), treatment emergent Serious Adverse Events (SAE) and treatment emergent Adverse Events of Special Interest (AESI) Timeframe: Up to approximately 24 months 2. Number of Participants with TEAEs leading to dose modifications or study intervention discontinuation Timeframe: Up to approximately 24 months 3. Number of Participants with Clinically Significant Findings in Vital signs, Electrocardiogram (ECG), and Laboratory test parameters Timeframe: Up to approximately 24 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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.) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) ## Sites - GSK Investigational SiteNew Haven, United States - GSK Investigational SiteIowa City, United States - GSK Investigational SiteSt Louis, United States - GSK Investigational SiteColumbus, United States - GSK Investigational SiteMilwaukee, United States - GSK Investigational SiteBuenos Aires, Argentina - GSK Investigational SiteCapital Federal, Argentina - GSK Investigational SiteCiudad Autonoma de Bueno, Argentina - GSK Investigational SiteCórdoba, Argentina - GSK Investigational SiteFlorida, Argentina - GSK Investigational SiteMendoza, Argentina - GSK Investigational SiteSan Juan, Argentina - GSK Investigational SiteSanta Fe, Argentina - GSK Investigational SiteSanto André, Brazil - GSK Investigational SiteSão Paulo, Brazil - GSK Investigational SiteSão Paulo, Brazil - GSK Investigational SiteCalgary, Canada - GSK Investigational SiteEdmonton, Canada - GSK Investigational SiteToronto, Canada - GSK Investigational SiteToronto, Canada - GSK Investigational SiteMontreal, Canada - GSK Investigational SiteHerlev, Denmark - GSK Investigational SiteTurku, Finland - GSK Investigational SiteBordeaux, France - GSK Investigational SiteCaen, France And 83 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) ## References ### Other registry identifiers (2) - 2023 - 2023-503428-24 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06062420) ## Related records ### Drugs (4) - [Belrestotug](https://trialight.com/data/asset/belrestotug-8b42a452-65fb-46e5-9c7c-f2106bd60d56.md) - [Dostarlimab](https://trialight.com/data/asset/dostarlimab-aad06b17-e988-4591-813f-4b6cef63860f.md) - [Nelistotug](https://trialight.com/data/asset/nelistotug-4fa295f8-c7a6-45c9-bd45-9f23118cd297.md) - [Remzistotug](https://trialight.com/data/asset/remzistotug-35f43491-4c28-4cfa-b332-8ca06abb7f55.md) ### Collaborators (1) - iTeos Therapeutics ### Lead sponsors (1) - [GlaxoSmithKline](https://trialight.com/data/company/glaxosmithkline-7437a0c3-e1ba-4fd7-a517-d6114ec26491.md) ### Conditions (2) - [Head and neck neoplasm](https://trialight.com/data/condition/head-and-neck-neoplasm-6436d68c-825f-5a7a-bb29-99e9ae9e009a.md) - [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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