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NCT04735978 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced Solid Tumor, sponsored by Replimune.

Active
Registry status
Phase 1
Development phase
123
Enrollment target
13
Study locations

NCT04735978: Active Phase 1 study of Advanced Solid Tumor, sponsored by Replimune.

NCT04735978 is a Phase 1 study of Advanced Solid Tumor that is active but no longer recruiting, run by Replimune. The registered enrollment target is 123 participants, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (36% lower). The trial reports 13 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04735978, a Phase 1 study of Advanced Solid Tumor, is active but no longer recruiting, sponsored by Replimune.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
123 participants
Enrollment target
13
Study locations

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.

Primary Outcome

Percentage of participants with DLTs

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
Replimune

9 total trials

What the registry record for NCT04735978 still lists

NCT04735978 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (36% lower).

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.

NCT04735978 lists 13 locations in 5 states (Other, Iowa, Pennsylvania).

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.

What interventions are being tested in trial NCT04735978?

The interventions under investigation include: Nivolumab (BIOLOGICAL), RP3 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04735978?

This trial is sponsored by Replimune, which has 9 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Advanced Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04735978's enrollment target sits among peer trials

123 103rd of 189 higher than 87 of 189 other Advanced Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04735978, the US trial registry maintained by the National Library of Medicine. NCT04735978 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.