MedTrace Logo

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

NCT03767348 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2026-02-13

No results posted yet for this 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).

Conditions

  • Non-Small Cell Lung Cancer (NSCLC)
  • Microsatellite Instability-High (MSI-H)
  • Non-melanoma Skin Cancer (NMSC)
  • Cutaneous Melanoma

Interventions

BIOLOGICAL

RP1

Genetically modified herpes simplex type 1 virus

BIOLOGICAL

nivolumab

anti-PD-1 monoclonal antibody

Sponsors & Collaborators

Principal Investigators

  • Jeannie Hou, MD · Replimune Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-20
Primary Completion
2028-06-30
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03767348 on ClinicalTrials.gov