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ACTIVE NOT RECRUITING Phase 1

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

NCT04735978 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

Interventions

  • BIOLOGICAL Nivolumab
  • BIOLOGICAL RP3

Study Locations (13)

Other

  • 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 Royal Marsden NHS Foundation Trust — London
  • Churchill Hospital — Oxford

Iowa

  • University of Iowa — Iowa City

Pennsylvania

  • UPMC Hillman Cancer Center — Pittsburgh

Texas

  • MD Anderson Cancer Center — Houston

Merseyside

  • The Clatterbridge Cancer Centre NHS Foundation Trust — Bebington

Trial Details

FieldValue
Enrollment Target 123 participants
Start Date 2020-12-29
Est. Completion 2026-11-30
Phase Phase 1

Sponsor

Replimune

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04735978

The ClinicalTrials.gov registry entry for NCT04735978 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Replimune, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 2 interventions — of which Nivolumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04735978 reports 13 study locations spanning 5 distinct geographic areas — top geographies include Other, Iowa, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04735978 about?

NCT04735978 is a clinical study titled "Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours". 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 recomm...

What is the current status of trial NCT04735978?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 123 participants. The study started on 2020-12-29. Estimated completion is 2026-11-30.

What conditions does trial NCT04735978 study?

This clinical trial studies the following conditions: Advanced Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04735978?

The interventions under investigation include: Nivolumab (BIOLOGICAL), RP3 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04735978?

This trial is sponsored by Replimune, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04735978 being conducted?

This trial has 13 study locations across Iowa, Pennsylvania, Texas, Merseyside. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial