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NCT04050436 · ClinicalTrials.gov registry record · Phase 2

Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer

A Phase 2 study of Cutaneous Squamous Cell Carcinoma and Metastatic Cutaneous Squamous Cell Carcinoma, sponsored by Replimune.

Active
Registry status
Phase 2
Development phase
231
Enrollment target
20
Study locations

NCT04050436 is a Phase 2 study of Cutaneous Squamous Cell Carcinoma and Metastatic Cutaneous Squamous Cell Carcinoma that is active but no longer recruiting, run by Replimune. The registered enrollment target is 231 participants, above the 80-participant average among 18 other Cutaneous Squamous Cell Carcinoma trials with a reported enrollment target (189% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT04050436, a Phase 2 study of Cutaneous Squamous Cell Carcinoma and Metastatic Cutaneous Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Replimune.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
231 participants
Enrollment target
20
Study locations

Study Summary

To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review.

Conditions Studied

Cutaneous Squamous Cell Carcinoma Metastatic Cutaneous Squamous Cell Carcinoma Advanced Cutaneous Squamous Cell Carcinoma

Interventions

  • DRUG Cemiplimab
  • BIOLOGICAL RP1

Study Locations (20)

California

  • University of California San Diego - La Jolla
  • University of California Los Angeles - Los Angeles
  • Stanford University - Stanford

Florida

  • University of Miami Health System - Miami
  • Orlando Health UF Health Cancer Center - Orlando
  • Moffitt McKinley Outpatient Center - Tampa

Victoria

  • Monash Medical Centre - Clayton
  • Peter MacCallum Cancer Centre - Melbourne
  • The Alfred Hospital - Melbourne

New South Wales

  • Chris O'Brien Lifehouse - Camperdown
  • Cancer Care Wollongong Pty Limited - Wollongong

Colorado

  • University of Colorado Cancer Center - Aurora

Georgia

  • Winship Cancer Institute of Emory University - Atlanta

New Jersey

  • John Theurer Cancer Center at Hackensack Univeristy Medical Center - Hackensack

New York

  • Memorial Sloan Kettering Cancer Center - New York

Trial Details

FieldValue
Enrollment Target 231 participants
Start Date 2019-10-08
Est. Completion 2025-09
Phase Phase 2

Sponsor

Replimune

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04050436

The ClinicalTrials.gov registry entry for NCT04050436 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 231 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 80-participant average among 18 other Cutaneous Squamous Cell Carcinoma trials with a reported enrollment target (189% higher). The listed sponsor is Replimune, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Cutaneous Squamous Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Cemiplimab is the first listed.

NCT04050436 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Victoria.

Frequently Asked Questions

What is clinical trial NCT04050436 about?

NCT04050436 is a clinical study titled "Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer". To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review.

What is the current status of trial NCT04050436?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 231 participants. The study started on 2019-10-08. Estimated completion is 2025-09.

What conditions does trial NCT04050436 study?

This clinical trial studies the following conditions: Cutaneous Squamous Cell Carcinoma, Metastatic Cutaneous Squamous Cell Carcinoma, Advanced Cutaneous Squamous Cell Carcinoma.

What interventions are being tested in trial NCT04050436?

The interventions under investigation include: Cemiplimab (DRUG), RP1 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04050436?

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

Where is trial NCT04050436 being conducted?

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

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.