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Clinical Trials in the UK / NCT03767348
Active, not recruiting Phase 2

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

NCT03767348 · tracked via the Priya Life Science UK tracker
Sponsor
Replimune, Inc.
Phase
Phase 2
Started
2017-09-20
Last updated
2026-02-13

Condition(s) studied

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

Investigational drug(s) / intervention(s)

RP1nivolumab

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. * At least one measurable and injectable lesion * Have provided a former tumor pathology specimen or be willing to supply a new tumor sample from a biopsy * Have a predicted life expectancy of ≥ 3 months * Measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria * Subjects with MSI-H or dMMR tumors: has diagnosis of MSI-H or metatstatic dMMR tumor (according to protocol definition) who has progressed on prior anti-PD1/PD-L1 therapy. * Subjects with NMSC: has diagnosis of locally advanced or metastatic NMSC that are not considered treatable by surgery including basal cell carcinoma, cutaneous squamous cell carcinoma, basosquamous carcinoma, Merkel cell carcinoma and other non-melanoma skin cancers (per protocol). Patients must have received 8 weeks of anti-PD1/PD-L1 as their last line of therapy and progressed while on treatment. * Subjects with anti-PD1 failed cutaneous melanoma: has confirmed progressive disease while on anti-PD1 treatment for at least 8 weeks and documented BRAF mutation status * Subjects with anti-PD1 failed NSCLC: must have failed prior treatment, including PD1/PD-L1 directed therapy administered either as monotherapy or in combination with platinum-based chemotherapy or anti-CTLA-4. The most recent treatment given must have included an anti-PD1/PD-L1 directed therapy with radiologic disease progression on or after treatment. Key Exclusion Criteria: * Prior treatment with an oncolytic therapy * History of viral infections according to the protocol * Prior complications with herpes infections * Chronic use of anti-virals * Uncontrolled/untreated brain metastasis * History of interstitial lung disease * History of non-infectious pneumonitis * History of clinically significant cardiovascular disease

Primary outcome measure(s)

Trial sites (51)

FacilityCityRegionStatus
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

Official registry record

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