Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)
← catalyst calendarNCT03767348 · readout ≤ 681 d
Sponsored by Replimune, Inc. (industry) · REPL — their whole pipeline →. With Bristol-Myers Squibb.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
340estimated
Sites
51
Countries
France, Germany, Spain +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2017-09-20 | actual | When the study began enrolling |
| Primary completion | Jun 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2018-12-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Microsatellite Instability-High (MSI-H)
- Non-melanoma Skin Cancer (NMSC)
- Cutaneous Melanoma
Interventions
- Biological: RP1
- Biological: nivolumab — also filed as Opdivo
Primary outcomes
what the primary-completion date above is the date OFPercentage of adverse events (AEs)
measured 26 months
Percentage of serious adverse events (SAEs)
measured 26 months
Percentage of dose limiting toxicities (DLTs)
measured 26 months
Percentage of overall response rate (ORR)
measured 26 months
Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1
measured 20 weeks
Publications
- PMID 40627813 — linked by the registry
- PMID 31399043 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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