Trials / Completed
CompletedNCT04717154
Ipilimumab With Nivolumab for Molecular-selected Patients With Castration-resistant Prostate Cancer
Phase 2 INSPIRE Trial: Ipilimumab With Nivolumab for Molecular- Selected Patients With Castration-resistant Prostate Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- Radboud University Medical Center · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the effects of 4 cycles of combinatory immunotherapy (ipilimumab and nivolumab), followed by monotherapy nivolumab in participants with immunogenic metastatic castration-resistant prostate cancer.
Detailed description
Following molecular characterization (next-generation sequencing) a total of 75 mCRPC patients with a putative immunogenic subtype will be included within the phase 2 INSPIRE trial. As treatment we will be utilizing a combinatory regimen of nivolumab 3mg/kg and ipilimumab 1mg/kg for 4 doses, followed by nivolumab 480mg flat dose for up to one year. All participants will additionally undergo an on-trial metastatic tissue biopsy. Translational research will study immunological correlates and in-depth genomic/transcriptomic and multispectral immunohistochemical analyses of immune infiltrate.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ipilimumab | 4 courses of 1mg/kg q3w |
| BIOLOGICAL | Nivolumab | 4 courses of 3mg/kg q3w, followed by maintenance flat dose (480mg, q4w, for 10 doses) |
Timeline
- Start date
- 2021-01-19
- Primary completion
- 2024-08-15
- Completion
- 2025-12-18
- First posted
- 2021-01-20
- Last updated
- 2026-01-06
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT04717154. Inclusion in this directory is not an endorsement.