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NCT02518958 · ClinicalTrials.gov registry record · Phase 1
A Phase I, Open-Label, Multiple Ascending Dose Study of RRx-001 and Nivolumab
A Phase 1 study of Lymphoma and Malignant Solid Tumor, sponsored by EpicentRx.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT02518958: Completed Phase 1 study of Lymphoma and Malignant Solid Tumor, sponsored by EpicentRx.
NCT02518958 is a Phase 1 study of Lymphoma and Malignant Solid Tumor that has completed, run by EpicentRx. The registered enrollment target is 12 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02518958, a Phase 1 study of Lymphoma and Malignant Solid Tumor, has completed, sponsored by EpicentRx.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG RRx-001
Study Locations (1)
Maryland
- Walter Reed National Military Medical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2015-07-21 |
| Est. Completion | 2016-09-12 |
| Phase | Phase 1 |
What the finished NCT02518958 record still lists
NCT02518958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT02518958 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02518958 about?
NCT02518958 is a clinical study titled "A Phase I, Open-Label, Multiple Ascending Dose Study of RRx-001 and Nivolumab". 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 ...
What is the current status of trial NCT02518958?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2015-07-21. Estimated completion is 2016-09-12.
What conditions does trial NCT02518958 study?
This clinical trial studies the following conditions: Lymphoma, Malignant Solid Tumor.
What interventions are being tested in trial NCT02518958?
The interventions under investigation include: Nivolumab (DRUG), RRx-001 (DRUG).
Who is sponsoring clinical trial NCT02518958?
This trial is sponsored by EpicentRx, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02518958 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02518958's enrollment target sits among peer trials
12 269th of 299 higher than 28 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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