Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Incidence of dose limiting toxicities (DLTs) during the DLT period — From Day 1 up to 30 days after last dose
Percentage of participants with DLTs - Incidence and severity of treatment emergent adverse events (TEAEs) — From Day 1 up to 60 days after last dose
Percentage of participants with TEAEs - Incidence and severity of serious adverse events (SAEs) — From Day 1 up to 60 days after last dose
Percentage of participants with SAEs - Incidence of TEAEs ≥ Grade 3 — From Day 1 up to 60 days after last dose
Percentage of participants with TEAEs ≥ Grade 3 - Percentage of events requiring withdrawal — From Day 1 up to last dose (up to 8 weeks in escalation phase and up to 2 years in combination phase)
Percentage of participants experiencing events requiring withdrawal from treatment. - Recommended phase 2 dose (RP2D) of RP3 — 7 months
RP2D of RP3 based on the safety and response data collected during the dose escalation phase (Part 1)
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
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 NCT04735978 on ClinicalTrials.gov ↗ ← All trials in the UK