Reversing Therapy Resistance With Epigenetic-Immune Modification

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT02395627
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Tamoxifen — DRUG
  • Vorinostat — DRUG
  • Pembrolizumab — DRUG

Study Details

The investigators propose a randomized two arm trial, using Simon's 2-stage design, in ER+ patients with therapy resistant breast cancer to test the optimal sequence and dosing of epigenetic immune priming in hormone therapy resistance breast cancer. A third arm (Arm C) will include ER-negative patients who will follow the concurrent priming, but exclude tamoxifen. The two arms all include vorinostat, tamoxifen, and pembrolizumab to evaluate * Sequential priming - begin pembrolizumab in Cycle 1 (Arm B and Arm C) and, * Concurrent priming with maximal dosing of both epigenetic and immune modulators- begin pembrolizumab on day 1 in Cycle 2 (Arm A)

Key Dates

Start date
May 4, 2015
Status verified
Jun 2020
Primary completion
Jun 8, 2019
Completion
Jun 8, 2019

Study Design

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

Arms

  • Experimental: Pembrolizumab Cycle 1 (Group A)
    Tamoxifen: 20 mg daily orally (starting at Cycle 1) Vorinostat: 400 mg 5 days every 7 orally (starting at Cycle 1) Pembrolizumab: 200 mg every 3 weeks intravenously (starting at Cycle 1)
  • Experimental: Pembrolizumab Cycle 2 (Group B)
    Tamoxifen: 20 mg daily orally (starting at Cycle 1) Vorinostat: 400 mg 5 days every 7 orally (starting at Cycle 1) Pembrolizumab: 200 mg every 3 weeks intravenously (starting at Cycle 2)
  • Experimental: Pembrolizumab Cycle 1 (Group C)
    Vorinostat: 400 mg 5 days every 7 orally (starting at Cycle 1) Pembrolizumab: 200 mg every 3 weeks intravenously (starting at Cycle 1)

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San Francisco Medical CenterSan FranciscoCalifornia94115-

Find similar trials in San Francisco, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of California, San Francisco Medical Center· San Francisco, CA

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