Reversing Therapy Resistance With Epigenetic-Immune Modification
Status:
Terminated
Trial end date:
2019-06-08
Target enrollment:
Participant gender:
Summary
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)
Phase:
Phase 2
Details
Lead Sponsor:
Pamela Munster University of California, San Francisco