Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-17 @ 10:37 PM
Study NCT ID:
NCT02518958
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2015-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I, Open-Label, Multiple Ascending Dose Study of RRx-001 and Nivolumab
Sponsor:
EpicentRx, Inc.
Organization:
Study Overview
Official Title:
A Phase I, Open-Label, Multiple Ascending Dose Study to Assess the Safety and Tolerability of RRx-001 and Nivolumab in Subjects With Advanced Solid Tumors or Lymphomas For Which There Are No Currently Accepted Life-Prolonging Therapies (PRIMETIME)
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIMETIME
Brief Summary:
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.
Detailed Description:
This is an open-label dose escalation study, consisting of the following periods:
* 1\) Screening Period (Up to 16 days): Eligibility for the study will be determined by Screening tests, physical examination/medical history, and fulfillment of eligibility criteria. Potential participants are required to provide written informed consent prior to the performance of any study specific Screening procedures.
* 2\) Treatment Period (Day 1 to 57): Between 15 and 45 eligible male and female adult subjects will receive weekly RRx-001 for a total of nine doses and every other week nivolumab for a total of 5 doses (odd cycles) or 4 doses (even cycles). Study medication (RRx-001 and nivolumab) will be administered intravenously at the study center. The Treatment Period will end following the last dose of nivolumab. Subjects will attend the study center weekly for on-study assessments.
* 3\) Follow-up Period: Subjects that have completed nivolumab dosing will undergo a follow-up assessment monthly, up to 100 days, for the emergence of delayed toxicity with particular attention to delayed immune related toxicities.
* 1\) Screening Period (Up to 16 days): Eligibility for the study will be determined by Screening tests, physical examination/medical history, and fulfillment of eligibility criteria. Potential participants are required to provide written informed consent prior to the performance of any study specific Screening procedures.
* 2\) Treatment Period (Day 1 to 57): Between 15 and 45 eligible male and female adult subjects will receive weekly RRx-001 for a total of nine doses and every other week nivolumab for a total of 5 doses (odd cycles) or 4 doses (even cycles). Study medication (RRx-001 and nivolumab) will be administered intravenously at the study center. The Treatment Period will end following the last dose of nivolumab. Subjects will attend the study center weekly for on-study assessments.
* 3\) Follow-up Period: Subjects that have completed nivolumab dosing will undergo a follow-up assessment monthly, up to 100 days, for the emergence of delayed toxicity with particular attention to delayed immune related toxicities.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: