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NCT02601014 · ClinicalTrials.gov registry record · Phase 2
Biomarker-Driven Therapy With Nivolumab and Ipilimumab in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Expressing AR-V7
A Phase 2 study of Prostate Cancer and Recurrent Prostate Carcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT02601014: Completed Phase 2 study of Prostate Cancer and Recurrent Prostate Carcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT02601014 is a Phase 2 study of Prostate Cancer and Recurrent Prostate Carcinoma that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 32 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02601014, a Phase 2 study of Prostate Cancer and Recurrent Prostate Carcinoma, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well nivolumab and ipilimumab work in treating patients with hormone-resistant prostate cancer that has spread to other places in the body and express androgen receptor-variant-7 (AR-V7). Tumor cells expressing AR-V7 has been shown to be resistant to hormone therapy and some chemotherapy in patients with prostate cancer. Biomarker-driven therapy, such as nivolumab and ipilimumab, may work by blocking key biomarkers or proteins that help tumor cells to escape the immune system surveillance and this may help the immune system to kill tumor cells that express AR-V7.
Primary Outcome
Number of participants with greater than 50% decline in PSA from start of treatment, sustained for \>= 4 weeks, as defined by Prostate Cancer Working Group 2 (PCWG2) criteria.
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
- DRUG Enzalutamide
- BIOLOGICAL Ipilimumab
Study Locations (1)
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2016-03-15 |
| Est. Completion | 2021-10-06 |
| Phase | Phase 2 |
What the finished NCT02601014 record still lists
NCT02601014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT02601014 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02601014 about?
NCT02601014 is a clinical study titled "Biomarker-Driven Therapy With Nivolumab and Ipilimumab in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Expressing AR-V7". This phase II trial studies how well nivolumab and ipilimumab work in treating patients with hormone-resistant prostate cancer that has spread to other places in the body and express androgen receptor-variant-7 (AR-V7). Tumor cells expressing AR-V7 has been shown to be resistant to hormone therapy a...
What is the current status of trial NCT02601014?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2016-03-15. Estimated completion is 2021-10-06.
What conditions does trial NCT02601014 study?
This clinical trial studies the following conditions: Prostate Cancer, Recurrent Prostate Carcinoma, Stage IV Prostate Adenocarcinoma.
What interventions are being tested in trial NCT02601014?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Enzalutamide (DRUG), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02601014?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02601014 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02601014's enrollment target sits among peer trials
32 566th of 735 higher than 159 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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