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NCT04349436 · ClinicalTrials.gov registry record · Phase 1

Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies

A Phase 1 study of Cancer and Merkel Cell Carcinoma, sponsored by Replimune.

Recruiting
Registry status
Phase 1
Development phase
90
Enrollment target
20
Study locations

NCT04349436: Recruiting Phase 1 study of Cancer and Merkel Cell Carcinoma, sponsored by Replimune.

NCT04349436 is a Phase 1 study of Cancer and Merkel Cell Carcinoma that is actively recruiting participants, run by Replimune. The registered enrollment target is 90 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04349436, a Phase 1 study of Cancer and Merkel Cell Carcinoma, is actively recruiting participants, sponsored by Replimune.

RECRUITING
Registry status
Phase 1
Development phase
90 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to assess the safety and efficacy of RP1 (administered into the tumor) in 90 patients who have received an organ transplant in the past and currently have skin cancer. The skin cancer is either locally advanced (large tumors in the skin, muscles or nerves) or metastatic (spread to other parts of the body). This study will consist of a 28-day Screening Period, a Treatment Period, and a Follow-up Period. During the Treatment Period, patients will be dosed with RP1 every two weeks for up to 2 years (104 weeks). Tumor measurements will be done approximately every 8 weeks (and additionally if needed) until progressive disease, start of subsequent anticancer therapy, or completion/discontinuation of the study. During the Follow-up Period, patients will visit the clinic at 30, 60, and 100-150 days after their last dose of RP1 for safety and quality of life assessments. Patients will continue follow-up for up to 3 years from the day of the last patient's first dose.

Primary Outcome

The effect of RP1 on objective response rate (ORR) as assessed by Independnet Central Review (ICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

Conditions Studied

Cancer Merkel Cell Carcinoma Basal Cell Carcinoma Locally Advanced Cutaneous Squamous Cell Carcinoma

Interventions

  • BIOLOGICAL RP1, intra-tumoral injection, oncolytic virus

Study Locations (20)

California

  • University of California, San Diego - La Jolla
  • University of California, Los Angeles - Los Angeles
  • UCSF, Helen Diller Family Comprehensive Cancer Center - San Francisco

Florida

  • Mayo Clinic Florida - Jacksonville
  • University of Miami Sylvester Comprehensive Cancer Center - Miami
  • Moffitt Cancer Center - Tampa

Arizona

  • Medical Dermatology Specialists - Phoenix
  • Mayo Clinic Arizona - Phoenix

New York

  • Columbia University Medical Center - New York
  • Rochester Dermatologic Surgery - New York

North Carolina

  • University of North Carolina Lineberger Comprehensive Cancer Center - Chapel Hill
  • Duke University - Durham

Ohio

  • University of Cincinnati - Cincinnati
  • The Cleveland Clinic Foundation - Cleveland

Colorado

  • University of Colorado Cancer Center School of Medicine - Aurora

Illinois

  • University of Chicago - Chicago

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2020-05-15
Est. Completion 2029-11
Phase Phase 1
Replimune

9 total trials

What NCT04349436 shows while recruiting

NCT04349436 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (97% lower).

The record links to 4 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which RP1, intra-tumoral injection, oncolytic virus is the first listed.

NCT04349436 names 20 study sites across 12 states, led by California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT04349436 about?

NCT04349436 is a clinical study titled "Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies". The purpose of this study is to assess the safety and efficacy of RP1 (administered into the tumor) in 90 patients who have received an organ transplant in the past and currently have skin cancer. The skin cancer is either locally advanced (large tumors in the skin, muscles or nerves) or metastatic ...

What is the current status of trial NCT04349436?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2020-05-15. Estimated completion is 2029-11.

What conditions does trial NCT04349436 study?

This clinical trial studies the following conditions: Cancer, Merkel Cell Carcinoma, Basal Cell Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma.

What interventions are being tested in trial NCT04349436?

The interventions under investigation include: RP1, intra-tumoral injection, oncolytic virus (BIOLOGICAL).

Who is sponsoring clinical trial NCT04349436?

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

Where is trial NCT04349436 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Cancer

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 NCT04349436's enrollment target sits among peer trials

90 337th of 615 higher than 277 of 615 other Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cancer 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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More recruiting context for NCT04349436

Source: ClinicalTrials.gov NCT04349436, the US trial registry maintained by the National Library of Medicine. NCT04349436 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.