An Investigational Immunotherapy Study to Determine Which Combination of Nivolumab plus Several Other Drugs, is the Most Effective in Treating Castration-resistant Prostate Cancer That Has Spread
- Conditions
- Castration-resistant Metastatic Prostate CancerMedDRA version: 20.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-001626-17-ES
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 300
- Histologic confirmation of adenocarcinoma of the prostate
- Evidence of metastatic disease
- Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast
- Participants with active brain metastases
- Participants must have recovered from the effects of major surgery requiring general anesthesia or significant traumatic injury at least 14 days before treatment arm assignment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To evaluate the objective response rate per PCWG3 (ORR-PCWG3) in HRD+ participants and in all treated participants<br>- To evaluate PSA response rate (RR-PSA) in HRD+ participants and in all treated participants;Secondary Objective: - To evaluate radiographic progression-free survival (rPFS) in HRD+ participants and in all treated participants<br>- To evaluate time to response (TTR) and duration of response (DOR) per PCWG3 (TTR-PCWG3 and DOR-PCWG3) in HRD+ participants and in all treated participants<br>- To estimate time to PSA progression (TTP-PSA) in HRD+ participants and in all treated participants<br>- To assess overall survival (OS) in HRD+ participants and in all treated participants<br>- To evaluate overall safety and tolerability;Primary end point(s): 1/ Objective Response Rate (ORR)<br>2/ Prostate-specific antigen response rate (RR-PSA);Timepoint(s) of evaluation of this end point: 1/ Approximately 12 months<br>2/ Approximately 12 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1/ Radiographic progression-free survival (rPFS)<br>2/ Time to response (TTR)<br>3/ Duration of response (DOR)<br>4/ Time to prostate-specific antigen progression (TTP-PSA)<br>5/ Overall Survival (OS)<br>6/ Incidence of adverse events (AEs)<br>7/ Incidence of serious adverse events (SAEs);Timepoint(s) of evaluation of this end point: 1/ Approximately 12 months<br>2/ Approximately 12 months<br>3/ Approximately 12 months<br>4/ Approximately 12 months<br>5/ Up to 5 years<br>6/ Approximately 12 months<br>7/ Approximately 12 months