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NCT03543189 · ClinicalTrials.gov registry record · Phase 1

Combination of Nivolumab Immunotherapy With Radiation Therapy and Androgen Deprivation Therapy

A Phase 1 study of Prostate Cancer and Prostate Disease, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Active
Registry status
Phase 1
Development phase
44
Enrollment target
1
Study location

NCT03543189 is a Phase 1 study of Prostate Cancer and Prostate Disease that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 44 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03543189, a Phase 1 study of Prostate Cancer and Prostate Disease, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
44 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to test the safety, tolerability, and effectiveness of the investigational drug nivolumab (Opdivo™) in combination with high dose radiation. Investigators also want to see if these study drugs help to delay the progression of prostate cancer.

Interventions

  • RADIATION External Beam Radiation Therapy
  • RADIATION Brachytherapy
  • DRUG Nivolumab
  • DRUG Androgen Deprivation Therapy

Study Locations (1)

Florida

  • H. Lee Moffitt Cancer Center and Research Institute - Tampa

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2018-10-03
Est. Completion 2026-12
Phase Phase 1

What the Registry Record Tells You About NCT03543189

The ClinicalTrials.gov registry entry for NCT03543189 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 44 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 (93% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which External Beam Radiation Therapy is the first listed.

NCT03543189 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT03543189 about?

NCT03543189 is a clinical study titled "Combination of Nivolumab Immunotherapy With Radiation Therapy and Androgen Deprivation Therapy". The purpose of this study is to test the safety, tolerability, and effectiveness of the investigational drug nivolumab (Opdivo™) in combination with high dose radiation. Investigators also want to see if these study drugs help to delay the progression of prostate cancer.

What is the current status of trial NCT03543189?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2018-10-03. Estimated completion is 2026-12.

What conditions does trial NCT03543189 study?

This clinical trial studies the following conditions: Prostate Cancer, Prostate Disease.

What interventions are being tested in trial NCT03543189?

The interventions under investigation include: External Beam Radiation Therapy (RADIATION), Brachytherapy (RADIATION), Nivolumab (DRUG), Androgen Deprivation Therapy (DRUG).

Who is sponsoring clinical trial NCT03543189?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03543189 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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