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Clinical Trials in the UK / NCT04735978
Active, not recruiting Phase 1

Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours

NCT04735978 · tracked via the Priya Life Science UK tracker
Sponsor
Replimune, Inc.
Phase
Phase 1
Started
2020-12-29
Last updated
2026-02-27

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

RP3Nivolumab

RP3: Genetically modified HSV-1

Nivolumab: anti-PD1 monoclonal antibody

Study summary

This is a Phase 1, multicenter, open label, single agent dose escalation and combination treatment study of RP3 in adult participants with advanced solid tumors, to evaluate the safety and tolerability of RP3 both as a single agent and in combination with anti-PD1 therapy and to determine the recommended Phase 2 dose (RP2D) of RP3.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Patients with advanced or metastatic non-neurological solid tumors, who have progressed on standard therapy or cannot tolerate standard therapy, or for whom there is no standard therapy preferred to enrollment in a clinical study * All patients must consent to provide archival tumor biopsy samples within 12 months, or a fresh tumor biopsy is needed. Patients must also consent to provide on treatment biopsies as per protocol * At least one measurable tumor ≥ 1 cm in longest diameter (or shortest diameter for lymph nodes) * At least one injectable tumor ≥ 1 cm in longest diameter or injectable tumors which in aggregate are ≥ 1 cm in longest diameter (or shortest diameter for lymph nodes * Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Note: Predefined inclusion criteria may apply for each additional expansion cohort. Exclusion Criteria: * Prior treatment with an oncolytic virus therapy * History of viral infections according to the protocol * Systemic infection requiring intravenous (IV) antibiotics * Active significant herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis) * Requires intermittent or chronic use of systemic antivirals a. Hepatocellular carcinoma patients with a diagnosis of hepatitis B must be off antiviral therapy for at least 4 weeks prior to enrollment . Hepatocellular carcinoma patients with a history of or ongoing hepatitis C infection must have completed treatment for hepatitis C at least 1 month prior to study enrollment and hepatitis * History of interstitial lung disease * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis Additional Exclusion Criteria for Patients Enrolled in Part 2 (Expansion Cohorts): * History of life-threatening toxicity related to prior immune treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways * Treatment with botanical preparations within 2 weeks prior to treatment. * Active, known, or suspected autoimmune disease requiring systemic treatment. * History of interstitial lung disease. * Severe hypersensitivity to another monoclonal antibody. * Has received prior radiotherapy within 2 weeks of start of study treatment. * Has received a live vaccine within 28 days prior to the first dose of study treatment. * History of (non-infectious) pneumonitis that required steroids or has current pneumonitis. * History of myocarditis or congestive heart failure within 6 months of screening. * Has a serious or uncontrolled medical disorder. * Has a QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 480 msec, except for right bundle branch block.

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
University of Iowa Iowa City Iowa
UPMC Hillman Cancer Center Pittsburgh Pennsylvania
MD Anderson Cancer Center Houston Texas
Laboratoire de Recherche Translationnelle en Immunotherapie (LRTI), Gustave Roussy Villejuif France
University of Athens Athens Greece
University General Hospital Attikon Athens Greece
Vall d'Hebron Hospital Hospital Universitario Vall d´Hebron (Vall d'Hebron University Hospital) Barcelona Spain
Hospital Clinic Barcelona Barcelona Spain
START Madrid CIO Clara Campal, Hospital Universitario HM Sanchinarro Unidad de Ensayos Fase I Panta 3 Madrid Spain
Hospital Clinico Universitario de Valencia Valencia Spain
The Clatterbridge Cancer Centre NHS Foundation Trust Bebington Merseyside
The Royal Marsden NHS Foundation Trust London United Kingdom
Churchill Hospital Oxford United Kingdom

On this site

📄 Opdivo (nivolumab) drug profile →

More Replimune, Inc. trials in the UK

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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 NCT04735978 on ClinicalTrials.gov ↗ ← All trials in the UK