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

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. According to ClinicalTrials.gov, the official US trial registry.

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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
Replimune

9 total trials

What the registry record for NCT04050436 still lists

NCT04050436 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, above the 80-participant average among 18 other Cutaneous Squamous Cell Carcinoma trials with a reported enrollment target (189% higher).

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 names 20 study sites across 13 states, led by 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.

Learn More About Clinical Trials

Similar trials for Cutaneous Squamous Cell Carcinoma

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 NCT04050436's enrollment target sits among peer trials

231 3rd of 18 higher than 16 of 18 other Cutaneous Squamous Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cutaneous Squamous Cell Carcinoma 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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Related registry views

Source: ClinicalTrials.gov NCT04050436, the US trial registry maintained by the National Library of Medicine. NCT04050436 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.