Neoadjuvant PROSTVAC-VF With or Without Ipilimumab for Prostate Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Lawrence Fong
Study ID
NCT02506114
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • PROSTVAC V/F — BIOLOGICAL
    PROSTVAC-V/F is a prostate-specific antigen(PSA)-based immunization strategy. It is intended to generate immune responses to prostate specific antigens and prostate cancer cells. It uses poxviral vectors to introduce modified PSA to the patient in an immunogenic manner to break self-tolerance, and thereby induce immune responses directed against prostate cancer cells.
  • Ipilimumab — DRUG

Study Details

This is a multicentered, open label, randomized phase II trial of PROSTVAC or ipilimumab or the combination of PROSTVAC and ipilimumab as neoadjuvant therapy in patients with localized prostate cancer. Eligible patients will be randomized to PROSTVAC monotherapy (Arm A), ipilimumab monotherapy (Arm B), or combination therapy with both PROSTVAC and ipilimumab (Arm C), prior to RP. In arms A and C, PROSTVAC-V will be administered subcutaneously as the primary vaccine on Day 1, which will be followed 2 weeks later with a series of 2 PROSTVAC-F subcutaneous administrations, given 3 weeks apart. In arms B and C, ipilimumab will be administered twice, at a dose of 3mg/kg, 3 weeks apart. In the combination arm, ipilimumab administration will coincide with the PROSTVAC-F administration. In arm B, ipilimumab will begin on Day 1. In all three arms, radical prostatectomy (RP) will occur 21 days, or three weeks, following final treatment administration of PROSTVAC or ipilimumab. No further therapy will be administered on study following RP.

Key Dates

Start date
Oct 6, 2016
Status verified
Oct 2021
Primary completion
Apr 22, 2020
Completion
Apr 22, 2020

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: PROSTVAC-V/F
    PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36.
  • Experimental: Arm B: Ipilimumab Monotherapy
    Ipilimumab: 3 mg/kg; intravenously; Days 1 and 21.
  • Experimental: Arm C: Combined PROSTVAC-V/F + Ipilimumab
    PROSTVAC-V: 2 x 10\^8pfu; subcutaneous; Day 1. PROSTVAC-F: 1 x 10\^9pfu; subcutaneous; Days 15, and 36. Ipilimumab: 3 mg/kg; intravenously; Days 15 and 36.

Primary Outcome Measure

Proportion of Participants With Positive CD3+ T Cell Immune Response [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-

Find similar trials in San Francisco, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California, San Francisco· San Francisco, CA

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