A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, efficacy, tolerability, and toxicity of docetaxel alone, in combination with BMS-986218, or in combination with nivolumab plus BMS-986218 in men who have metastatic castration-resistant prostate cancer (mCRPC) that progressed after novel antiandrogen therapy and have not received chemotherapy for mCRPC.

Official 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

Conditions
-----------------
Prostatic Neoplasms, Castration-Resistant

Intervention / Treatment
-----------------
* Biological: BMS-986218
* Drug: Docetaxel
* Biological: Nivolumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic confirmation of carcinoma of the prostate without small cell features Documented prostate cancer progression by Prostate Cancer Working Group 3 (PCWG3) criteria while castrate Evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography (CT)/magnetic resonance imaging (MRI) Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or bilateral orchiectomy (i.e., surgical or medical castration) confirmed by testosterone level ≤ 1.73 nmol/L (50 ng/dL) at the screening visit Chemotherapy-naive for metastatic castration-resistant prostate cancer (mCRPC) and have received at least one novel antiandrogen therapy (NAT) Exclusion Criteria: Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment in Part 1 or randomization in Part 2 Untreated central nervous system (CNS) metastases Leptomeningeal metastases Active, known or suspected autoimmune disease Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1A: Docetaxel + BMS-986218<br> | Biological: BMS-986218<br>* Specified dose on specified days<br>Drug: Docetaxel<br>* Specified dose on specified days<br>* Other names: TAXOTERE;|
| Experimental: Arm 1B: Docetaxel + BMS-986218 + Nivolumab<br> | Biological: BMS-986218<br>* Specified dose on specified days<br>Drug: Docetaxel<br>* Specified dose on specified days<br>* Other names: TAXOTERE;Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558, MDX1106, ONO-4538;|
| Experimental: Arm 2A: Docetaxel<br> | Drug: Docetaxel<br>* Specified dose on specified days<br>* Other names: TAXOTERE;|
| Experimental: Arm 2B: Docetaxel + BMS-986218<br> | Biological: BMS-986218<br>* Specified dose on specified days<br>Drug: Docetaxel<br>* Specified dose on specified days<br>* Other names: TAXOTERE;|
| Experimental: Arm 2C: Docetaxel + BMS-986218 + Nivolumab<br> | Biological: BMS-986218<br>* Specified dose on specified days<br>Drug: Docetaxel<br>* Specified dose on specified days<br>* Other names: TAXOTERE;Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558, MDX1106, ONO-4538;|
| Experimental: Arm 2D (Optional Crossover): BMS-986218 + Nivolumab<br> | Biological: BMS-986218<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558, MDX1106, ONO-4538;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) | Part 1 | Up to 2 years | 
| Number of deaths | Part 1 | Up to 2 years | 
| Radiographic progression-free survival (rPFS) assessed by blinded independent central review (BICR) per Prostate Cancer Working Group 3 (PCWG3) | Part 2 | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate per Prostate Cancer Working Group 3 (ORR-PCWG3) | Part 2 | Up to 4 years | 
| Time to response per Prostate Cancer Working Group 3 (TTR-PCWG3) as determined by BICR | Part 2 | Up to 4 years | 
| Duration of response per Prostate Cancer Working Group 3 (DOR-PCWG3) as determined by BICR | Part 2 | Up to 4 years | 
| Prostate-specific antigen response rate (PSA-RR) | Part 2 | Up to 4 years | 
| Time to prostate-specific antigen progression (TTP-PSA) per PCWG3 | Part 2 | Up to 4 years | 
| Overall survival (OS) | Part 2 | Up to 4 years | 
| Number of participants with adverse events (AEs) | Part 2 | Up to 2 years | 
| Number of deaths | Part 2 | Up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BMS-986218, BMS-936558, Docetaxel, Metastatic, MDX1106, Nivolumab, ONO-4538, TAXOTERE