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NCT06062420 · ClinicalTrials.gov registry record · 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
A Phase 2 study of Neoplasms, Head and Neck, sponsored by GlaxoSmithKline.
- Active
- Registry status
- Phase 2
- Development phase
- 316
- Enrollment target
- 20
- Study locations
NCT06062420: Active Phase 2 study of Neoplasms, Head and Neck, sponsored by GlaxoSmithKline.
NCT06062420 is a Phase 2 study of Neoplasms, Head and Neck that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 316 participants, roughly in line with the 331-participant average among 4 other Neoplasms, Head and Neck trials with a reported enrollment target. The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06062420, a Phase 2 study of Neoplasms, Head and Neck, is active but no longer recruiting, sponsored by GlaxoSmithKline.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 316 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Dostarlimab
- DRUG Remzistotug
- DRUG Belrestotug
- DRUG Nelistotug
Study Locations (20)
Other
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Capital Federal
- GSK Investigational Site - Ciudad Autonoma de Bueno
- GSK Investigational Site - Córdoba
- GSK Investigational Site - Florida
- GSK Investigational Site - Mendoza
- GSK Investigational Site - San Juan
- GSK Investigational Site - Santa Fe
- GSK Investigational Site - Santo André
- GSK Investigational Site - São Paulo
- GSK Investigational Site - São Paulo
Alberta
- GSK Investigational Site - Calgary
- GSK Investigational Site - Edmonton
Ontario
- GSK Investigational Site - Toronto
- GSK Investigational Site - Toronto
Connecticut
- GSK Investigational Site - New Haven
Iowa
- GSK Investigational Site - Iowa City
Missouri
- GSK Investigational Site - St Louis
Ohio
- GSK Investigational Site - Columbus
Wisconsin
- GSK Investigational Site - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2023-11-14 |
| Est. Completion | 2027-07-22 |
| Phase | Phase 2 |
What the registry record for NCT06062420 still lists
NCT06062420 is an interventional study that assigns participants to a tested intervention. The registered 316 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 331-participant average among 4 other Neoplasms, Head and Neck trials with a reported enrollment target.
The record links to 1 condition, with Neoplasms, Head and Neck appearing as the primary indexed condition, and to 4 interventions - of which Dostarlimab is the first listed.
NCT06062420 names 20 study sites across 8 states, led by Other, Alberta, Ontario.
Frequently Asked Questions
What is clinical trial NCT06062420 about?
NCT06062420 is a clinical study titled "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". 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).
What is the current status of trial NCT06062420?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 316 participants. The study started on 2023-11-14. Estimated completion is 2027-07-22.
What conditions does trial NCT06062420 study?
This clinical trial studies the following conditions: Neoplasms, Head and Neck.
What interventions are being tested in trial NCT06062420?
The interventions under investigation include: Dostarlimab (DRUG), Remzistotug (DRUG), Belrestotug (DRUG), Nelistotug (DRUG).
Who is sponsoring clinical trial NCT06062420?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06062420 being conducted?
This trial has 20 study locations across Connecticut, Iowa, Missouri, Ohio, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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