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Reversing Therapy Resistance With Epigenetic-Immune Modification

NCT02395627 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-07-07

Study results available
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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)

Conditions

  • Breast Neoplasms

Interventions

DRUG

Tamoxifen

DRUG

Vorinostat

DRUG

Pembrolizumab

Sponsors & Collaborators

Principal Investigators

  • Pamela Munster, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-04
Primary Completion
2019-06-08
Completion
2019-06-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02395627 on ClinicalTrials.gov