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ACTIVE NOT RECRUITING Phase 2

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)

NCT03767348 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 340 participants
Start Date 2017-09-20
Est. Completion 2028-12
Phase Phase 2

Sponsor

Replimune

8 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 340 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Replimune, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Cutaneous Melanoma appearing as the primary indexed condition, and to 2 interventions — of which nivolumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03767348 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, New York, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Cutaneous Melanoma, Non-Small Cell Lung Cancer (NSCLC), Non-melanoma Skin Cancer (NMSC), Microsatellite Instability-High (MSI-H). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03767348?

The interventions under investigation include: nivolumab (BIOLOGICAL), RP1 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03767348?

This trial is sponsored by Replimune, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial