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A Randomized, Double-blind, Placebo-controlled Phase 3 study to evaluate Dostarlimab as Sequential Therapy after Chemoradiation in Participants with Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508613-17-00
Acronym
221530
Enrollment
355
Registered
2024-04-29
Start date
2024-05-29
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck, Neoplasms

Brief summary

Event Free Survival (EFS) where an event is defined as: • First record of locoregional progression or recurrence, or distant metastasis per RECIST 1.1 as per BICR, • Salvage surgery at the primary tumor site when invasive cancer is present, • Neck dissection or surgery performed >20 weeks after completion of CRT when invasive cancer is present, • Death from any cause.

Detailed description

OS, defined as time from randomization to death from any cause, Event Free Survival (EFS) where an event is defined as: • First record of locoregional progression or recurrence, or distant metastasis per RECIST 1.1 as per investigator assessment. • Salvage surgery at the primary tumor site when invasive cancer is present. • Neck dissection or surgery performed >20 weeks after completion of CRT when invasive cancer is present. • Death from any cause., Frequency and severity of TEAEs, immune-mediated TEAEs, SAEs TEAE/SAEs leading to dose delays, withdrawal or death. Clinically significant changes in laboratory, vital signs, and safety assessment parameters, Serum concentrations and relevant PK parameters (C-EoI and C trough) for dostarlimab, Incidence of ADA against dostarlimab

Interventions

DRUGJEMPERLI 500 mg concentrate for solution for infusion
DRUGLocally sourced sterile 0.9% (w/v) sodium chloride

Sponsors

Glaxosmithkline Research & Development Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Event Free Survival (EFS) where an event is defined as: • First record of locoregional progression or recurrence, or distant metastasis per RECIST 1.1 as per BICR, • Salvage surgery at the primary tumor site when invasive cancer is present, • Neck dissection or surgery performed >20 weeks after completion of CRT when invasive cancer is present, • Death from any cause.

Secondary

MeasureTime frame
OS, defined as time from randomization to death from any cause, Event Free Survival (EFS) where an event is defined as: • First record of locoregional progression or recurrence, or distant metastasis per RECIST 1.1 as per investigator assessment. • Salvage surgery at the primary tumor site when invasive cancer is present. • Neck dissection or surgery performed >20 weeks after completion of CRT when invasive cancer is present. • Death from any cause., Frequency and severity of TEAEs, immune-mediated TEAEs, SAEs TEAE/SAEs leading to dose delays, withdrawal or death. Clinically significant changes in laboratory, vital signs, and safety assessment parameters, Serum concentrations and relevant PK parameters (C-EoI and C trough) for dostarlimab, Incidence of ADA against dostarlimab

Countries

Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Norway, Poland, Portugal, Romania, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026