Clinical Trial

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

Study acronym: IGNYTE
Active, Not Recruiting Phase 2
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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).
Protocol Amendment History 1 change
notable Sponsor changed: Replimune Inc. -> Replimune, Inc. 2026-04-19
Trial Details
NCT Number NCT03767348
Lead Sponsor Replimune Inc.
Collaborators: Bristol-Myers Squibb
Conditions Non-Small Cell Lung Cancer (NSCLC), Microsatellite Instability-High (MSI-H), Non-melanoma Skin Cancer (NMSC), Cutaneous Melanoma
Enrollment 340 participants
Start Date 2017-09-20
Primary Completion 2028-06 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-13