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Neoadjuvant Listeria or Daratumumab in Prostate Cancer

NCT03035357 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-05-03

No results posted yet for this study

Summary

The goal of this clinical research study is to learn about biomarker changes in patients who have primary prostate cancer after receiving Darzalex (daratumumab) and then have a prostatectomy (the surgical removal of the prostate) as part of their standard care. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drug.

Conditions

Interventions

DRUG

Daratumumab

16 mg/kg by vein once weekly for a total of 4 doses.

Sponsors & Collaborators

  • Janssen-Cilag div. of Johnson&Johnson SE

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Sumit K. Subudhi, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2019-03-01
Completion
2019-03-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03035357 on ClinicalTrials.gov