A Randomized, Controlled, Multicenter, Phase 3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination with Nivolumab Versus Treatment of Physician’s Choice in Patients with Advanced Melanoma That Has Progressed on an Anti-PD-1 and an Anti-CTLA-4 Containing Treatment Regimen [IGNYTE-3]

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508612-29-00

Acronym

RP1-104

Enrollment

193

Registered

2025-07-15

Start date

2025-11-07

Completion date

Unknown

Last updated

2025-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Melanoma

Brief summary

Overall survival (OS)

Detailed description

Progression-free survival (PFS) (as per Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST 1.1]), ORR (as per RECIST 1.1), Complete response rate (CRR), Duration of response (DOR), Disease control rate (DCR), PFS at 1 and 2 years, Survival rates at 1, 2 and 3 years, Frequency, nature, and severity of treatment-emergent adverse events (TEAEs), including serious adverse events

Interventions

DRUGVusolimogene oderparepvec

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGPaclitaxel 6mg/ml Concentrate for Solution for Infusion

DRUGDacarbazine medac 100 mg

DRUGpowder for solution for injection/infusion

DRUGTEMOZOLOMIDE VIATRIS 5 mg

DRUGgélule

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGOpdualag 240 mg/80 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS)	—

Secondary

Measure	Time frame
Progression-free survival (PFS) (as per Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST 1.1]), ORR (as per RECIST 1.1), Complete response rate (CRR), Duration of response (DOR), Disease control rate (DCR), PFS at 1 and 2 years, Survival rates at 1, 2 and 3 years, Frequency, nature, and severity of treatment-emergent adverse events (TEAEs), including serious adverse events	—

Countries

France, Germany, Greece, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026