A Phase I, Open-Label, Multiple Ascending Dose Study of RRx-001 and Nivolumab

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
EpicentRx, Inc.
Study ID
NCT02518958
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a dose escalation protocol to determine the feasibility of co-administration of RRx-001 and nivolumab. Immune surveillance is an endogenous mechanism to cause remission of neoplastic growth. Epigenetic agents like RRx-001 are associated not only with enhanced gene transcription and restored expression of silenced genes but also with increased expression of pro-inflammatory mediators, upregulation of PD-L1 on tumor cells and de-repression of antigens that promote immune recognition of tumors. It is hypothesized that RRx-001, will prime or sensitize to immune checkpoint therapy targeting PD-1 interaction with nivolumab.

Key Dates

Start date
Jul 21, 2015
Status verified
Nov 2019
Primary completion
May 17, 2016
Completion
Sep 12, 2016

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RRx-001 + Nivolumab
    Patients enrolled in this trial will receive study drug (RRx-001) on Day 1 as a single agent. Nivolumab (3 mg/kg) will be administered on Day 2 or Day 3 as a single agent.

Primary Outcome Measure

Number, frequency and type of adverse events [ Time Frame: 23 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Walter Reed National Military Medical CenterBethesdaMaryland20889-

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By research site
Walter Reed National Military Medical Center· Bethesda, MD

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