CO39385: Study of Atezolizumab + Enzalutamide vs Enzalutamide in mCRPC
Research type
Research Study
Full title
A PHASE III, MULTICENTER, RANDOMIZED STUDY OF ATEZOLIZUMAB (ANTI−PD-L1 ANTIBODY) IN COMBINATION WITH ENZALUTAMIDE VERSUS ENZALUTAMIDE ALONE IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER AFTER FAILURE OF AN ANDROGEN SYNTHESIS INHIBITOR AND FAILURE OF, INELIGIBILITY FOR, OR REFUSAL OF A TAXANE REGIMEN
IRAS ID
220398
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2016-003092-22
Clinicaltrials.gov Identifier
131196, IND
Duration of Study in the UK
2 years, 7 months, 29 days
Research summary
Prostate cancer is the most commonly diagnosed cancer in men and despite recent advances in the treatment of prostate cancer, patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) experience significant morbidity and mortality related to their disease and the median life expectancy from time of first metastatic diagnosis remains less than 3 years.
Atezolizumab is an immune checkpoint inhibitor; it acts by targeting the PD-1 PD-L1 axis and is approved in a spectrum of other cancers outside of prostate cancer.
This Phase III, multicentre, randomised, open-label study aims to evaluate the safety and efficacy of atezolizumab in patients with mCRPC.A total of 558 participants will take part in this study globally, where atezolizumab will be given in combination with enzalutamide. There will be an initial safe run in for this to ensure the combination is safe (not in the UK). Participants will be randomly assigned to receive atezolizumab in combination with enzalutamide or enzalutamide alone every 21-day cycle until disease progression or unacceptable toxicity. Participants will be stratified according to prior taxane-containing treatment amongst others.
Participants who receive immunotherapy drugs sometimes experience an increase in the size or number of their tumours before their disease starts to shrink. Therefore, upon initial apparent disease progression, selected participants may be considered for continued treatment until unacceptable toxicity or loss of clinical benefit, provided certain conditions are met.
Safety (including standard blood tests, ECG), tumour assessments and quality of life questionnaires will be carried out during the study. In addition, pharmacokinetics, pharmacodynamics biomarkers and the measurement of antibodies directed against the study drugs and other components of the drug product will be investigated.
There will be approximately 40 participants recruited at 8 UK sites.
REC name
London - Hampstead Research Ethics Committee
REC reference
17/LO/0249
Date of REC Opinion
14 Feb 2017
REC opinion
Favourable Opinion