209227 Pembro + 5FU-platinum chemo +/- GSK3359609 (ICOS) in HNSCC
Research type
Research Study
Full title
A Randomized, Double-Blind, Adaptive, Phase II/III Study of GSK3359609 in Combination with Pembrolizumab and 5FU-Platinum Chemotherapy versus Placebo in Combination with Pembrolizumab plus 5FU-Platinum Chemotherapy for First-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
IRAS ID
263351
Contact name
Piyush Mehta
Contact email
Eudract number
2019-003981-42
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
143221, IND
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Summary of Research
Head and neck squamous cell carcinoma (HNSCC) is a commonly occurring cancer. Despite treatment advances more than half of patients eventually experience a return of their disease (recurrence) which has likely spread to other parts of the body (metastatic). With current chemotherapy the expected median survival for patients with this disease remains under 15 months.
GSK3359609 and Pembrolizumab are two investigational medicines which work by stimulating the immune system to kill the cancer. Pembrolizumab is approved in the USA and Europe for treatment of HNSCC.
The purpose of this study is to evaluate if adding GSK3359609 with Pembrolizumab plus a doublet-chemotherapy (5-Flurouracil + a platinum-based drug (either carboplatin or cisplatin)) reduces disease progression, and prolongs survival, in people with recurrent/metastatic HNSCC.
Participants will undergo an eligibility assessment involving review of blood tests, vital signs, ECG, echocardiogram, physical exam and disease assessment scans (e.g. CT-scan). All eligible participants will receive Pembrolizumab and chemotherapy. A computer randomly assigns participants to receive GSK3359609 or a placebo (dummy drug). Neither the participants nor the study doctor can choose the treatment or will know what treatment the participant is receiving.
Chemotherapy is given for the first six treatments with the Pembrolizumab and GSK3359609/Placebo. Following this, chemotherapy is stopped whilst the Pembrolizumab and GSK3359609/Placebo continue up to a maximum of 35 treatments or 2 years. Each of these drugs is given via intravenous injection.
Before each treatment, safety blood samples are collected, participants complete questionnaires and undergo a brief physical exam. Participants will be treated until disease progression, unacceptable side effects or death. To help understand the effects of GSK3359609, additional blood samples may be collected.
It is anticipated most participants will be in the study for approximately 4-9 months. Once treatment has stopped participants will be followed-up to document their further treatment(s) and survival information.
Summary of Results
Plain Language Summary 209227 Plain Language Summary_ English Version 11 Apr 2023 (v1.0) was sent to all PI's to share with patients enrolled in the trial.
REC name
London - Central Research Ethics Committee
REC reference
20/LO/0954
Date of REC Opinion
25 Aug 2020
REC opinion
Further Information Favourable Opinion