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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
GlaxoSmithKline
Study ID
NCT06062420
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Neoplasms, Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dostarlimab — DRUG
    Dostarlimab will be administered.
  • Belrestotug — DRUG
    Belrestotug will be administered.
  • Nelistotug — DRUG
    Nelistotug will be administered.
  • Remzistotug — DRUG
    Remzistotug will be administered.

Study Details

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).

Key Dates

Start date
Nov 14, 2023
Status verified
May 2026
Primary completion
Sep 1, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
316 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dostarlimab Monotherapy
  • Experimental: Sub study 1: Dostarlimab and Belrestotug
  • Experimental: Sub study 2: Dostarlimab and nelistotug
  • Experimental: Sub study 3: Dosarlimab and Belrestotug and nelistotug
  • Experimental: Sub study 4: Dostarlimab and remzistotug

Primary Outcome Measure

Confirmed Objective Response Rate (ORR) compared between Sub studies and Dostarlimab monotherapy [ Time Frame: Up to approximately 24 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteNew HavenConnecticut06511-
GSK Investigational SiteIowa CityIowa52242-
GSK Investigational SiteSt LouisMissouri63021-
GSK Investigational SiteColumbusOhio43210-
GSK Investigational SiteMilwaukeeWisconsin53226-

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