Phase 3
N=1,030
A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04100018 ↗Enrolled (actual)
1,030
Serious AEs
48.8%
Results posted
Jul 2024
Primary outcome: Primary: Radiographic Progressive Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group 3 (PCWG3) — 9.43; 8.74 months — p=0.5901
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nivolumab (Biological); Prednisone (Drug); Docetaxel (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiographic Progressive Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group 3 (PCWG3) |
9.43; 8.74 | 0.5901 |
| PRIMARY Overall Survival (OS) |
18.73; 18.92 | 0.3572 |
| SECONDARY Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3) |
27.3; 23.5 | — |
| SECONDARY Time to Response (TTR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3) |
2.17; 2.20 | — |
| SECONDARY Duration of Response Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3) |
8.31; 8.11 | — |
| SECONDARY Prostate-specific Antigen (PSA) Response Rate (PSA-RR) |
42.4; 41.6 | — |
| SECONDARY Time to PSA Progression (TTP-PSA) |
6.28; 6.21 | — |
| SECONDARY Number of Participants With Adverse Events |
501; 503 | — |
| SECONDARY Number of Participants With Serious Adverse Events |
223; 192 | — |
| SECONDARY Number of Participants With Adverse Events Leading to Discontinuation |
148; 101 | — |
| SECONDARY Number of Participants With Endocrine Immune-Mediated Adverse Events |
7; 4; 27; 11; 1; 0 | — |
| SECONDARY Number of Participants With Non-Endocrine Immune-Mediated Adverse Events |
15; 2; 5; 1; 1; 0 | — |
| SECONDARY Number of Participants With Select Adverse Events |
176; 159; 7; 2; 2; 1 | — |
| SECONDARY Number of Participants Who Died |
258; 227 | — |
| SECONDARY Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline |
5; 3; NA; NA; 20; 16 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests |
94; 77; 79; 54; 39; 20 | — |
| SECONDARY Time to Pain Progression as Assessed by Brief Pain Inventory-Short Form (BPI-SF) |
11.53; 12.42 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04100018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.