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NCT04717154: INSPIRE
Ipilimumab With Nivolumab for Molecular-selected Patients With Castration-resistant Prostate Cancer
Phase 2 trial testing Ipilimumab in Prostatic Neoplasms, Castration-Resistant in 69 participants. Completed in 18 December 2025.
15 August 2024
Quick facts
| Lead sponsor | Radboud University Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 69 |
| Start date | 19 January 2021 |
| Primary completion | 15 August 2024 |
| Estimated completion | 18 December 2025 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Ipilimumab — full drug profile →
- Nivolumab (nivolumab) — full drug profile →
Conditions studied
- Prostatic Neoplasms, Castration-Resistant — all drugs for Prostatic Neoplasms, Castration-Resistant →
Sponsor
Radboud University Medical Center
Who can join
18 and older, male only, with Prostatic Neoplasms, Castration-Resistant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Tumor immunotherapies by immune checkpoint inhibitors (ICIs); the pros and cons.
Naimi A, Mohammed RN, Raji A, Chupradit S, et al · · 2022 · cited 350× · PMID 35392976 · DOI 10.1186/s12964-022-00854-y -
Homologous Recombination Repair Deficiency and Implications for Tumor Immunogenicity.
van Wilpe S, Tolmeijer SH, Koornstra RHT, de Vries IJM, et al · · 2021 · cited 44× · PMID 34067105 · DOI 10.3390/cancers13092249 -
Immune Checkpoint Inhibitors in Advanced Prostate Cancer: Current Data and Future Perspectives.
Rebuzzi SE, Rescigno P, Catalano F, Mollica V, et al · · 2022 · cited 40× · PMID 35267553 · DOI 10.3390/cancers14051245 -
The Immunotherapy and Immunosuppressive Signaling in Therapy-Resistant Prostate Cancer.
Xu P, Wasielewski LJ, Yang JC, Cai D, et al · · 2022 · cited 29× · PMID 35892678 · DOI 10.3390/biomedicines10081778 -
Molecular Mechanisms of Prostate Cancer Development in the Precision Medicine Era: A Comprehensive Review.
Maekawa S, Takata R, Obara W. · · 2024 · cited 27× · PMID 38339274 · DOI 10.3390/cancers16030523 -
Evaluating Immune Checkpoint Blockade in Metastatic Castration-Resistant Prostate Cancers with Deleterious CDK12 Alterations in the Phase 2 IMPACT Trial.
Nguyen CB, Reimers MA, Perera C, Abida W, et al · · 2024 · cited 24× · PMID 38787530 · DOI 10.1158/1078-0432.ccr-24-0400 -
The nerve growth factor-delivered signals in prostate cancer and its associated microenvironment: when the dialogue replaces the monologue.
Di Donato M, Giovannelli P, Migliaccio A, Castoria G. · · 2023 · cited 23× · PMID 36941697 · DOI 10.1186/s13578-023-01008-4 -
Immunological facets of prostate cancer and the potential of immune checkpoint inhibition in disease management.
Hansen SB, Unal B, Kuzu OF, Saatcioglu F. · · 2024 · cited 21× · PMID 39629128 · DOI 10.7150/thno.100555
Verify or expand the search:
- PubMed search for NCT04717154
- Europe PMC full search
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Other recruiting trials for Prostatic Neoplasms, Castration-Resistant
Currently open trials in the same condition.
- NCT07225946 — A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Canc · Phase 3 · recruiting
- NCT06706921 — 18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer · Phase 4 · recruiting
- NCT06353386 — Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Particip · Phase 1, PHASE2 · recruiting
- NCT05743621 — Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer · Phase 1 · recruiting
- NCT05393791 — Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC · Phase 2 · recruiting
Other Radboud University Medical Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04717154 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Radboud University Medical Center
- Last refreshed: 6 January 2026
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