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NCT04717154: INSPIRE

Ipilimumab With Nivolumab for Molecular-selected Patients With Castration-resistant Prostate Cancer

Completed Phase 2 Last updated 6 January 2026
What this trial tests

Phase 2 trial testing Ipilimumab in Prostatic Neoplasms, Castration-Resistant in 69 participants. Completed in 18 December 2025.

Timeline
19 January 2021
Primary endpoint
15 August 2024
18 December 2025

Quick facts

Lead sponsorRadboud University Medical Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment69
Start date19 January 2021
Primary completion15 August 2024
Estimated completion18 December 2025
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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:

Other trials of Ipilimumab

Trials testing the same drug.

Other recruiting trials for Prostatic Neoplasms, Castration-Resistant

Currently open trials in the same condition.

Other Radboud University Medical Center trials

Trials by the same sponsor.

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Data sources for this page

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