Dostarlimab in participants with Locally Advanced Unresected HNSCC
Research type
Research Study
Full title
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.
IRAS ID
1009198
Contact name
Robert Lang
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Research summary
This study is being carried out to test the potential benefit of dostarlimab versus placebo (a salt solution with no medicine) given after chemoradiotherapy (CRT) in participants with locally advanced head and neck (H&N) cancer that cannot be surgically removed, to see if the treatment can delay or reduce the risk of cancer returning. Dostarlimab, is a type of drug being developed by GSK to help the immune system to fight H&N cancer. Participants with H&N cancer in the study are at least 18 years old, have completed chemoradiotherapy for their cancer, have not undergone surgery or other treatments for their cancer, and the cancer must express a protein called PD-L1.
The Study has 3 parts: There is a screening period starting after CRT has finished when several tests are run to see if the participant qualifies for the study. Then a 12-month treatment period, when dostarlimab or placebo (assigned randomly by computer) is administered via a vein in the arm, during 11 clinic visits over 1 year. The treatment may be stopped earlier if the cancer worsens, or there are unacceptable side-effects. Neither the participants nor doctors will know which treatment the participant is receiving. Finally, a follow up period when the participant visits the clinic every 3 to 6 months to run tests to assess the participant’s health and to check if the cancer has returned or worsened. The tests include measuring vital signs, blood tests to check your organs, and CT or MRI imaging scans. Participants will undergo a medical history review and also complete questionnaires about their quality of life/symptoms. Participants may be on the study for up to 5 years in total.
This study will include up to 864 participants globally, with approximately 18 participants being recruited from UK hospitals.REC name
East of England - Essex Research Ethics Committee
REC reference
24/EE/0068
Date of REC Opinion
10 May 2024
REC opinion
Further Information Favourable Opinion