Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours (NCT04735978)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (19 items).
Location: University of Iowa — Iowa City, Iowa
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (13 Sites)
- 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,
- University of Athens — Athens,
- University General Hospital Attikon — Athens,
- Vall d'Hebron Hospital Hospital Universitario Vall d´Hebron (Vall d'Hebron University Hospital) — Barcelona,
- Hospital Clinic Barcelona — Barcelona,
- START Madrid CIO Clara Campal, Hospital Universitario HM Sanchinarro Unidad de Ensayos Fase I Panta 3 — Madrid,
- Hospital Clinico Universitario de Valencia — Valencia,
- The Clatterbridge Cancer Centre NHS Foundation Trust — Bebington, Merseyside
- The Royal Marsden NHS Foundation Trust — London,
- Churchill Hospital — Oxford,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.