CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 340 target
Drug / intervention
RP1 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03767348
NCT03767348Phase 2ActiveOn TrackUpdated 4mo ago
CompareCT.gov

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors [IGNYTE]

Replimune, Inc.·interventional·Posted Dec 6, 2018·Updated Feb 13, 2026

In Brief

A Phase 2 clinical trial evaluating RP1 and nivolumab for Non-Small Cell Lung Cancer (NSCLC) and 3 related conditions. Active but no longer recruiting, targeting 340 participants across 51 sites in 5 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer (NSCLC), Microsatellite Instability-High (MSI-H), Non-melanoma Skin Cancer (NMSC), Cutaneous Melanoma
CountriesFrance, Germany, Spain, United Kingdom, United States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2Active
201820192020202120222023202420252026202720282029
First PostedDec 6, 2018
Enrollment StartSep 20, 2017
Primary CompletionJun 1, 2028
Study CompletionDec 1, 2028
TodayJul 2, 2026
Enrollment to primary: 10.7 yearsPosted 7.6 years agoPrimary completion in 1.9 years

Interventions

RP1biological

Genetically modified herpes simplex type 1 virus

nivolumabbiological

anti-PD-1 monoclonal antibody