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NCT03204812 · ClinicalTrials.gov registry record · Phase 2

Durvalumab and Tremelimumab in Treating Chemotherapy Naive Patients With Metastatic Castration-Resistant Prostate Cancer

A Phase 2 study of Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
31
Enrollment target
1
Study location

NCT03204812 is a Phase 2 study of Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8 that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 31 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03204812, a Phase 2 study of Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
31 participants
Enrollment target
1
Study location

Study Summary

This phase II trial studies the safety, tolerability and how well durvalumab and tremelimumab work in treating participants with castration-resistant prostate cancer who have not received chemotherapy (chemotherapy naïve) and has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Conditions Studied

Prostate Adenocarcinoma Stage IVB Prostate Cancer AJCC v8 Castration-Resistant Prostate Carcinoma Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Metastatic Malignant Neoplasm in the Bone

Interventions

  • BIOLOGICAL Durvalumab
  • BIOLOGICAL Tremelimumab

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2017-07-14
Est. Completion 2021-04-13
Phase Phase 2

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03204812

The ClinicalTrials.gov registry entry for NCT03204812 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (86% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab is the first listed.

NCT03204812 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT03204812 about?

NCT03204812 is a clinical study titled "Durvalumab and Tremelimumab in Treating Chemotherapy Naive Patients With Metastatic Castration-Resistant Prostate Cancer". This phase II trial studies the safety, tolerability and how well durvalumab and tremelimumab work in treating participants with castration-resistant prostate cancer who have not received chemotherapy (chemotherapy naïve) and has spread to other places in the body (metastatic). Immunotherapy with mo...

What is the current status of trial NCT03204812?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2017-07-14. Estimated completion is 2021-04-13.

What conditions does trial NCT03204812 study?

This clinical trial studies the following conditions: Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8.

What interventions are being tested in trial NCT03204812?

The interventions under investigation include: Durvalumab (BIOLOGICAL), Tremelimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT03204812?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03204812 being conducted?

This trial has 1 study location across Texas. 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.