Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT03886493
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.

Study Details

This is a single-center, single arm, open-label phase II study evaluating the safety, anti-tumor effect, and immunogenicity of neoadjuvant Dupixent given prior to radical prostatectomy.

Key Dates

Start date
Aug 28, 2019
Status verified
Sep 2021
Primary completion
Oct 6, 2020
Completion
Oct 6, 2020

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dupixent Subcutaneous (SQ) Injection
    Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints.

Primary Outcome Measure

Change in M2-TAM Infiltration From Baseline [ Time Frame: change from baseline to up to 59 days post-intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21228-

Find similar trials in Baltimore, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

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