Phase 2
Completed N=292
An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Source: ClinicalTrials.gov NCT03338790 ↗Enrolled (actual)
292
Serious AEs
59.3%
Results posted
Feb 2022
Primary outcomePrimary: Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3) — 10.3; 15.4; 40.0; 11.1 Percentage of participants
Summary
The purpose of this study is to assess safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3) |
10.3; 15.4; 40.0; 11.1; 17.2; 25.0 | — |
| PRIMARY Prostate-Specific Antigen Response Rate (RR-PSA) |
11.9; 27.3; 46.9; 34.1; 18.2; 41.9 | — |
| SECONDARY Radiographic Progression-Free Survival (rPFS) |
4.60; 8.15; 9.20; 5.75; 5.59; 11.01 | — |
| SECONDARY Time to Response Per Prostate Cancer Clinical Trials Working Group 3 (TTR-PCWG3) |
1.94; 1.95; 1.94; 1.9; 2.76; 2.07 | — |
| SECONDARY Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3) |
NA; 7.10; 7.21; NA; NA; 7.10 | — |
| SECONDARY Prostate-Specific Antigen Time to Progression (TTP-PSA) |
3.78; 3.45; 8.67; 3.09; 6.47; 10.25 | — |
| SECONDARY Overall Survival (OS) |
13.96; 20.24; 18.17; 17.41; 15.15; 23.00 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
88; 71; 83; 49; 49; 37 | — |
| SECONDARY Number of Participants Who Died |
79; 66; 76; 47 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities in Specific Liver Tests |
19; 23; 6; 4; 11; 15 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests |
23; 17; 12; 17; 18; 12 | — |
| SECONDARY Number of Participants With Laboratory Values Change From Baseline |
23; 21; 30; 8; 38; 28 | — |
Eligibility Criteria
Inclusion Criteria
- Histologic confirmation of adenocarcinoma of the prostate
- Evidence of stage IV disease on previous bone, CT, and/or MRI scan
- Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
- Mandatory plasma and fresh or archival tumor tissue must be submitted
Exclusion Criteria
- 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
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT03338790). 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. Informational only — not medical advice.