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NCT03767348 · ClinicalTrials.gov registry record · Phase 2
Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)
A Phase 2 study of Non-small Cell Lung Cancer (NSCLC) and Cutaneous Melanoma, sponsored by Replimune.
- Active
- Registry status
- Phase 2
- Development phase
- 340
- Enrollment target
- 20
- Study locations
NCT03767348 is a Phase 2 study of Non-small Cell Lung Cancer (NSCLC) and Cutaneous Melanoma that is active but no longer recruiting, run by Replimune. The registered enrollment target is 340 participants, above the 283-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT03767348, a Phase 2 study of Non-small Cell Lung Cancer (NSCLC) and Cutaneous Melanoma, is active but no longer recruiting, sponsored by Replimune.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 340 participants
- Enrollment target
- 20
- Study locations
Study Summary
The Phase 2 study is a multicenter, open-label study of RP1 to further investigate safety and to estimate the efficacy of RP1 at the RP2D in combination with nivolumab in patients with Stage IIIb-IV unresectable melanoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, non-melanoma skin cancer (NMSC), and non-small cell lung cancer (NSCLC).
Conditions Studied
Interventions
- BIOLOGICAL nivolumab
- BIOLOGICAL RP1
Study Locations (20)
California
- UC San Diego - La Jolla
- University of Southern California - Los Angeles
- UCLA - Los Angeles
- University of California, Irvine - Orange
- University of California- San Francisco - San Francisco
New York
- New York University Clinical Cancer Center - New York
- Weill Cornell Medical College - New York
- University of Rochester Medical Center - Rochester
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Mayo Clinic - Phoenix
Alabama
- University of Birmingham Alabama - Birmingham
Arkansas
- Carti Cancer Center - Little Rock
Florida
- Sylvester Comprehensive Cancer Center- University of Miami - Miami
Iowa
- University of Iowa-Cancer Center Research - Iowa City
Kentucky
- James Graham Brown Cancer Center- University of Louisville - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2017-09-20 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03767348
The ClinicalTrials.gov registry entry for NCT03767348 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 340 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 283-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (20% higher). The listed sponsor is Replimune, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 2 interventions - of which nivolumab is the first listed.
NCT03767348 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, New York, Arizona.
Frequently Asked Questions
What is clinical trial NCT03767348 about?
NCT03767348 is a clinical study titled "Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)". The Phase 2 study is a multicenter, open-label study of RP1 to further investigate safety and to estimate the efficacy of RP1 at the RP2D in combination with nivolumab in patients with Stage IIIb-IV unresectable melanoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) so...
What is the current status of trial NCT03767348?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 340 participants. The study started on 2017-09-20. Estimated completion is 2028-12.
What conditions does trial NCT03767348 study?
This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC), Cutaneous Melanoma, Non-melanoma Skin Cancer (NMSC), Microsatellite Instability-High (MSI-H).
What interventions are being tested in trial NCT03767348?
The interventions under investigation include: nivolumab (BIOLOGICAL), RP1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03767348?
This trial is sponsored by Replimune, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03767348 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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