Combining Ipilimumab With Abiraterone Acetate Plus Prednisone in Chemotherapy and Immunotherapy-naïve Patients With Progressive Metastatic Castration-resistant Prostate Cancer

StatusActive, Not Recruiting
PhasePhase 1/2
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
See other at-risk trials from Memorial Sloan Kettering Cancer Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 2026 to Sep 2027
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised at 1 of 3 sites
  2. Re-verified, no change to tracked fieldsv24
  3. Primary and study completion dates: Sep 2025 to Sep 2026
    • Enrollment target: 57 to 54
    v23
  4. Primary and study completion dates: Sep 2024 to Sep 2025v22
  5. Re-verified, no change to tracked fieldsv21
Show 19 earlier versionsHide 19 earlier versions
  1. Primary and study completion dates: Sep 2023 to Sep 2024v20
  2. Primary and study completion dates: Sep 2022 to Sep 2023v19
  3. Primary and study completion dates: Sep 2021 to Sep 2022v18
  4. Primary and study completion dates: Sep 2020 to Sep 2021v17
  5. Primary and study completion dates: Sep 2019 to Sep 2020v16
  6. Primary and study completion dates: Sep 2018 to Sep 2019v15
  7. Primary and study completion dates: Sep 2017 to Sep 2018v14
  8. Primary and study completion dates: Sep 2016 to Sep 2017v13
  9. 2 versions Re-verified since Sep 2, 2015, no change to tracked fieldsv11-v12
  10. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 3 of 3 sites
    v10
  11. Primary and study completion dates: Sep 2015 to Sep 2016v9
  12. Site details revised at 1 of 3 sitesv8
  13. Site details revised at 1 of 3 sitesv7
  14. Enrollment target: 25 to 57
    • Site contacts updated at 3 of 3 sites
    v6
  15. Trial status: Active, Not Recruiting to Recruiting
    • Primary and study completion dates: Sep 2014 to Sep 2015
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site details revised at 3 of 3 sites
    v5
  16. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 3 of 3 sites
    v4
  17. Re-verified, no change to tracked fieldsv3
  18. Study sites: 4 to 3
    • Collaborators: 4 to 3
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to find out what effects, good and/or bad, taking ipilimumab with abiraterone acetate plus prednisone has on the patient and the prostate cancer. Abiraterone acetate plus prednisone are drugs that lower testosterone (testosterone stimulates prostate cancer growth). Abiraterone acetate plus prednisone is a treatment for patients with prostate cancer. Abiraterone acetate plus prednisone has not been used together with ipilimumab before. This study will test how they work together. Each patient will receive abiraterone acetate, prednisone and ipilimumab.
Trial Details
NCT Number NCT01688492
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: Bristol-Myers Squibb, Northwestern University, Oregon Health and Science University
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov