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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 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.

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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.

Conditions Studied

Prostate Cancer Recurrent Prostate Carcinoma Stage IV Prostate Adenocarcinoma

Interventions

  • BIOLOGICAL Nivolumab
  • DRUG Enzalutamide
  • BIOLOGICAL Ipilimumab

Study Locations (1)

Maryland

  • Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2016-03-15
Est. Completion 2021-10-06
Phase Phase 2

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

523 total trials

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What the Registry Record Tells You About NCT02601014

The ClinicalTrials.gov registry entry for NCT02601014 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower). The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.