Combination therapy with Isatuximab in solid tumour patients
Research type
Research Study
Full title
A Phase 1/2 open-label, multi-centre, safety, preliminary efficacy and pharmacokinetic (PK) study of isatuximab (SAR650984) in combination with REGN2810 or isatuximab alone in patients with advanced malignancies
IRAS ID
239401
Contact name
Johann de Bono
Contact email
Sponsor organisation
Sanofi-aventis recherche & developpement
Eudract number
2017-002846-61
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
U1111-1197-7792, WHO universal trial number
Duration of Study in the UK
3 years, 0 months, 10 days
Research summary
Summary of Research
Isatuximab and REGN2810 are types of medications called monoclonal antibodies (a type of protein).
Non-Small Cell Lung Cancer (NSCLC) is a type of cancer of the lung. Approximately 80-85% of lung cancers are NSCLC. Patients with advanced NSCLC have a low survival rate.
Metastatic, castration resistant prostate cancer (mCRPC) is a cancer of the prostate where metastases are formed and is resistant to hormone therapy and androgen-deprivation therapy as a treatment. The prognosis for patients with mCRPC is poor.
Isatuximab and REGN2810 bind to tumour cells, helping the body’s immune system to kill them. The purpose of this study is to assess the risks (safety) and effectiveness of isatuximab when given in combination with REGN2810, or isatuximab alone in the treatment of patients with mCRPC or NSCLC.
The blood levels of isatuximab and REGN2810, participant’s immune response to the study medication, the effect of the study medication on disease progression and biomarkers will also be assessed in this study. If patients consent into the study, their DNA (genetic material) and the way they react to and handle the study medication will also be studied.
This study will include approximately 134 patients globally (approximately 98 with mCRPC and 36 with NSCLC), of which around 27 (19 mCRPC and 8 NSCLC) will be from the UK. Participants will receive Isatuximab and REGN2810 by an intravenous infusion (through the vein). Patients will continue to receive the study medication until their disease progresses, they experience unacceptable side effects, they or their study doctor decide to stop the study medication, or until patient has received two years of treatment without disease progression.
A pharmaceutical company (Sanofi) is sponsoring this study.
This study is planned to take part in 5 countries and 19 sites globally and in 2 NHS centres in England.
Summary of Results
Not available as this study is out of scope for Lay Summary because the protocol was approved before July 2018.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/0229
Date of REC Opinion
10 Apr 2018
REC opinion
Further Information Favourable Opinion