A Phase 2 Trial of BMS-986218 or BMS-986218/Nivolumab in Combination with Docetaxel in mCRPC
Research type
Research Study
Full title
A Phase 2, Open-label, Randomized Controlled Trial of BMS-986218 or BMS-986218 Plus Nivolumab in Combination with Docetaxel in Participants with Metastatic Castration-resistant Prostate Cancer
IRAS ID
1004609
Contact name
Head of Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2021-003990-74
Research summary
The purpose of this study is to assess the effectiveness and safety of combining an investigation drug called BMS-986218, or BMS-986218 plus nivolumab, with standard of care docetaxel (chemotherapy), in men who have metastatic castration-resistant prostate cancer (mCRPC) that progressed after novel antiandrogen therapy (NAT) and have not receivd chemotherapy for mCRPC. This study will investigate how participants with mCRPC tolerate these drugs and identify the most suitable dose of BMS-986218 in combination with docetaxel and BMS-986218 in combination with docetaxel and nivolumab. BMS-986218 is an investigational drug that is not approved for a particular use by a local health authority, Nivolumab and docetaxel have been administered to and are approved for human use in multiple tumour types. This study has 2 parts, Part 1 which is a dose finding safety portion and Part 2 which is a randomised (assigned treatment by chance) portion. The purpose of the Part 1 of the study is to evaluate different doses of the study drug to find a safe and well tolerated dose to be used in Part 2. In Part 1 participants may be treated with BMS-986218 in combination with docetaxel or BMS-986218 in combination with nivolumab and docetaxel. Part 2 participants will be randomised to 1 of 3 possible treatments; docetaxel alone, BMS-986218 in combination with docetaxel, or BMS-986218 in combination with nivolumab and docetaxel. Approx 204 participants e expected to enroll in the 2 parts of the study, in the US, UK & other countries. Participation is expected to be a maximum of 2 years. There are 3 periods to the study: Screening, Treatment and Follow-up . During the study participants will undergo the following: Physcical exam, medical history, ECG, blood & urine samples), questions about; medications & side effects, health & illness, ability to do daily activities, CT and/or MRI scans, tumour biopsies, quality of life questionnaires (Part 2 only), study drug administration
REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0257
Date of REC Opinion
13 Sep 2022
REC opinion
Further Information Favourable Opinion