Description:
The purpose of this study is to assess the safety and effectiveness of nivolumab with
docetaxel in men with advanced castration resistant prostate cancer who have progressed after
second-generation hormonal manipulation.
Title
- Brief Title: A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
- Official Title: A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer
Clinical Trial IDs
- ORG STUDY ID:
CA209-7DX
- SECONDARY ID:
2019-002030-36
- NCT ID:
NCT04100018
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Nivolumab | OPDIVO,, BMS-936558-01 | Arm A: Nivolumab + docetaxel + prednisone |
| Prednisone | | Arm A: Nivolumab + docetaxel + prednisone |
| Docetaxel | | Arm A: Nivolumab + docetaxel + prednisone |
Purpose
The purpose of this study is to assess the safety and effectiveness of nivolumab with
docetaxel in men with advanced castration resistant prostate cancer who have progressed after
second-generation hormonal manipulation.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Arm A: Nivolumab + docetaxel + prednisone | Experimental | | - Nivolumab
- Prednisone
- Docetaxel
|
| Arm B: Placebo + docetaxel + prednisone | Placebo Comparator | | |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Histologic confirmation of adenocarcinoma of the prostate without small cell features
- Current evidence of metastatic disease documented by either bone lesions on
radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic
resonance imaging (CT/MRI)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone
(GnRH) analogue or bilateral orchiectomy
- Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3)
criteria within 6 months prior to screening
- Chemotherapy-naïve for metastatic castration-resistant prostate cancer (mCRPC), with 1
to 2 prior second generation hormonal therapies in the recurrent non-metastatic
setting and/or metastatic setting, and no more than 1 second generation hormonal
therapy in the mCRPC setting. Must have progressed during or after second generation
hormonal therapy or have documented intolerance to second generation hormonal therapy
- Participants must meet one of the following criteria regarding tissue submission:
Sufficient tumor samples from a newly obtained ("fresh") biopsy (obtained during
screening); or archival tumor tissue in the form of formalin-fixed paraffin-embedded
(FFPE) block or unstained tumor tissue slides. For participants with bone-only disease
or inaccessible soft tissue lesions or if the biopsy procedure would pose an
unacceptable clinical risk for the participant, submission of tumor tissue obtained
from a fresh biopsy is not required.
- Men must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
- Active brain metastases
- Active, known, or suspected autoimmune disease
- Condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone
equivalent) or other immunosuppressive medications within 14 days of start of study
treatment. Inhaled or topical steroids or adrenal replacement steroid doses are
permitted in the absence of active autoimmune disease
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or
any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint
pathways
- Prior treatment with docetaxel or other chemotherapy for mCRPC. Prior docetaxel for
metastatic castration-sensitive prostate cancer is permitted if at least 12 months
have elapsed from last dose of docetaxel
Other protocol-defined inclusion/exclusion criteria apply
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Male |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Radiographic progressive free survival (rPFS) assessed by Blinded Independent Central Review (BICR) per Prostate Cancer Working Group (PCWG3) |
| Time Frame: | From the date of randomization to the first date of documented progression or death due to any cause, whichever occurs first, approximately 25 months |
| Safety Issue: | |
| Description: | Up to 433 rPFS events |
Secondary Outcome Measures
| Measure: | Objective Response Rate (ORR) per PCWG3 |
| Time Frame: | From the date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first, approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Time to Response per PCWG3 (TTR-PCWG3) determined by BICR |
| Time Frame: | From the date of randomization to the date of the first documented complete response (CR) or partial response (PR), approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of Response (DOR) per PCWG3 determined by BICR |
| Time Frame: | From the date of first response (CR/PR) to the date of first documented radiographic progression, or death due to any cause, approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Prostate-specific antigen (PSA) Response Rate (PSA-RR) |
| Time Frame: | Approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Time to PSA Progression (TTP-PSA) |
| Time Frame: | From date of randomization to the date of PSA progression per PCWG3, approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of Adverse Events (AEs) |
| Time Frame: | Approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of Serious Adverse Events (SAEs) |
| Time Frame: | Approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of AEs leading to discontinuation |
| Time Frame: | Approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of immune-mediated AEs |
| Time Frame: | Approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of deaths |
| Time Frame: | Approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of laboratory abnormalities: Clinical Chemistry Tests |
| Time Frame: | Approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of laboratory abnormalities: Hematology tests |
| Time Frame: | Approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of laboratory abnormalities: Serology tests |
| Time Frame: | Approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Median time to pain progression assessed by Brief Pain Inventory-Short Form (BPI-SF) |
| Time Frame: | Approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of changes from baseline in Physical Exam |
| Time Frame: | Approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of changes from baseline in vital signs: Respiratory rate |
| Time Frame: | Approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of changes from baseline in vital signs: Body temperature |
| Time Frame: | Approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of changes from baseline in vital signs: Blood pressure |
| Time Frame: | Approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of changes from baseline in vital signs: Heart Rate |
| Time Frame: | Approximately 25 months |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of changes from baseline electrocardiogram (ECG) |
| Time Frame: | Approximately 25 months |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
June 8, 2021
