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Clinical Trials in Denmark / NCT06062420
Active, not recruiting Phase 2

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 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 2
Started
2023-11-14
Last updated
2026-09-24

Condition(s) studied

Neoplasms, Head and Neck

Investigational drug(s) / intervention(s)

Dostarlimab →Belrestotug →Nelistotug →Remzistotug →

Dostarlimab: Dostarlimab will be administered.

Belrestotug: Belrestotug will be administered.

Nelistotug: Nelistotug will be administered.

Remzistotug: Remzistotug will be administered.

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

Sex
ALL
Min age
18 Years
Max age
—
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.)

Primary outcome measure(s)

Trial sites (108)

FacilityCityRegionStatus
GSK Investigational Site New Haven Connecticut
GSK Investigational Site Iowa City Iowa
GSK Investigational Site St Louis Missouri
GSK Investigational Site Columbus Ohio
GSK Investigational Site Milwaukee Wisconsin
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
GSK Investigational Site Edmonton Alberta
GSK Investigational Site Toronto Ontario
GSK Investigational Site Toronto Ontario
GSK Investigational Site Montreal Quebec
GSK Investigational Site Herlev Denmark
GSK Investigational Site Turku Finland
GSK Investigational Site Bordeaux France
GSK Investigational Site Caen France
GSK Investigational Site Marseille France
GSK Investigational Site Paris France
GSK Investigational Site Rouen France
GSK Investigational Site Villejuif France
GSK Investigational Site Frankfurt am Main Hesse
GSK Investigational Site Essen North Rhine-Westphalia
GSK Investigational Site Aachen Germany
GSK Investigational Site Berlin Germany
GSK Investigational Site Giessen Germany
GSK Investigational Site Hamburg Germany
GSK Investigational Site Regensburg Germany
GSK Investigational Site Ulm Germany
GSK Investigational Site Panórama Central Macedonia
GSK Investigational Site Haidari - Athens Greece
GSK Investigational Site Marousi Greece

+ 68 more sites — see the full list on the official registry below.

More GlaxoSmithKline trials in Denmark

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06062420 on ClinicalTrials.gov ↗ ← All trials in Denmark