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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: Active Phase 2 study of Non-small Cell Lung Cancer (NSCLC) and Cutaneous Melanoma, sponsored by Replimune.
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 279-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (22% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Percentage of subjects with adverse events (AEs)
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 |
What the registry record for NCT03767348 still lists
NCT03767348 is an interventional study that assigns participants to a tested intervention. The registered 340 participants enrollment target is mid-sized for trials with a published cap, above the 279-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (22% higher).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
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Where NCT03767348's enrollment target sits among peer trials
340 19th of 59 higher than 41 of 59 other Non-small Cell Lung Cancer (NSCLC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-small Cell Lung Cancer (NSCLC) 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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