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Active Not RecruitingNCT06062420

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

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

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
316 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGDostarlimabDostarlimab will be administered.
DRUGBelrestotugBelrestotug will be administered.
DRUGNelistotugNelistotug will be administered.
DRUGRemzistotugRemzistotug will be administered.

Timeline

Start date
2023-11-14
Primary completion
2026-09-01
Completion
2027-12-31
First posted
2023-10-02
Last updated
2026-04-09

Locations

108 sites across 20 countries: United States, Argentina, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Norway, Poland, Portugal, Romania, South Korea, Spain, Taiwan, Turkey (Türkiye)

Regulatory

Source: ClinicalTrials.gov record NCT06062420. Inclusion in this directory is not an endorsement.

A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurre (NCT06062420) · Clinical Trials Directory