Biomarker-Driven Therapy With Nivolumab and Ipilimumab in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Expressing AR-V7

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT02601014
Phase
PHASE2
Status
Completed

Conditions

  • Prostate Cancer
  • Recurrent Prostate Carcinoma
  • Stage IV Prostate Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Ipilimumab — BIOLOGICAL
    Given 1 mg/kg IV
  • Nivolumab — BIOLOGICAL
    Given 3 mg/kg IV
  • Enzalutamide — DRUG
    given orally per standard of care

Study Details

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.

Key Dates

Start date
Mar 15, 2016
Status verified
Jan 2022
Primary completion
Dec 3, 2020
Completion
Oct 6, 2021

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and ipilimumab
    Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.
  • Experimental: Enzalutamide plus Nivolumab and Ipilimumab
    Patients will continue on standard of care enzalutamide, with the addition of nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With Change in PSA Response [ Time Frame: up to 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-

Find similar trials in Baltimore, MD

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

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