Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)
Condition(s) studied
Investigational drug(s) / intervention(s)
RP1: Genetically modified herpes simplex type 1 virus
nivolumab: anti-PD-1 monoclonal antibody
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).
Eligibility
Primary outcome measure(s)
- Percentage of adverse events (AEs) — 26 months
Percentage of subjects with adverse events (AEs) - Percentage of serious adverse events (SAEs) — 26 months
Percentage of subjects with serious adverse events (SAEs) - Percentage of dose limiting toxicities (DLTs) — 26 months
Percentage of subjects with dose limiting toxicities (DLTs) - Percentage of overall response rate (ORR) — 26 months
Percentage of overall response rate (ORR) for all participants - Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1 — 20 weeks
Assess the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1 based on the safety and response data collected during Phase 1 Escalation
Trial sites (51)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Birmingham Alabama | Birmingham | Alabama | |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | |
| Mayo Clinic | Phoenix | Arizona | |
| Carti Cancer Center | Little Rock | Arkansas | |
| UC San Diego | La Jolla | California | |
| University of Southern California | Los Angeles | California | |
| UCLA | Los Angeles | California | |
| University of California, Irvine | Orange | California | |
| University of California- San Francisco | San Francisco | California | |
| Sylvester Comprehensive Cancer Center- University of Miami | Miami | Florida | |
| University of Iowa-Cancer Center Research | Iowa City | Iowa | |
| James Graham Brown Cancer Center- University of Louisville | Louisville | Kentucky | |
| Mayo Clinic | Rochester | Minnesota | |
| New York University Clinical Cancer Center | New York | New York | |
| Weill Cornell Medical College | New York | New York | |
| University of Rochester Medical Center | Rochester | New York | |
| Duke Cancer Center | Durham | North Carolina | |
| University of Cincinnati Medical Center | Cincinnati | Ohio | |
| Providence Portland Medical Center | Portland | Oregon | |
| MUSC Health | Charleston | South Carolina | |
| West Cancer Center | Germantown | Tennessee | |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | |
| Eccles Outpatient Care Center- Oncology Clinical Trials | Murray | Utah | |
| Intermountain Cancer Center- Saint George Cancer Center | St. George | Utah | |
| Seattle Cancer Care Alliance- University of Washington | Seattle | Washington | |
| University of Wisconsin-Carbone Cancer Center | Madison | Wisconsin | |
| CHU Besancon - Hopital Jean Minjoz | Besançon | France | |
| Institut Bergonié | Bordeaux | France | |
| CHU Dijon | Dijon | France | |
| Centre Léon Bérard Lyon | Lyon | France | |
| Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone | Marseille | France | |
| CHU de Nice Hôpital l'Archet | Nice | France | |
| Hôpital Saint Louis APHP | Paris | France | |
| Institut Gustave Roussy | Villejuif | France | |
| Charité (Campus Benjamin Franklin) | Berlin | Germany | |
| University Hospital Essen, Klinik für Dermatologie | Essen | Germany | |
| University of Kiel (UKSH), Dep. of Dermatology | Kiel | Germany | |
| Uniklinik Marburg | Marburg | Germany | |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | |
| Hospital Clinic Barcelona | Barcelona | Spain |
+ 11 more sites — see the full list on the official registry below.
On this site
📄 Opdivo (nivolumab) drug profile →More Replimune, Inc. trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03767348 on ClinicalTrials.gov ↗ ← All trials in the UK