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

ClinicalTrials.gov ID: NCT04050436

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Official title

A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination With RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04050436
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Replimune, Inc.; Industry
Enrollment: 231 participants

Conditions and interventions

Conditions

Interventions

Cemiplimab Drug
RP1 Biological

Drug · Biological

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 8, 2019 (Actual)
Primary completion: Sep 2025 (Estimated)
Completion: Sep 2025 (Estimated)
Last update posted: Jan 27, 2025

2019 – 2025

United States locations

U.S. sites: 14
U.S. states: 10
U.S. cities: 14

Facility	City	State	ZIP	Site status
University of California San Diego	La Jolla	California	92093	—
University of California Los Angeles	Los Angeles	California	90024	—
Stanford University	Stanford	California	94305	—
University of Colorado Cancer Center	Aurora	Colorado	80045	—
University of Miami Health System	Miami	Florida	33136	—
Orlando Health UF Health Cancer Center	Orlando	Florida	32806	—
Moffitt McKinley Outpatient Center	Tampa	Florida	33612	—
Winship Cancer Institute of Emory University	Atlanta	Georgia	30322	—
John Theurer Cancer Center at Hackensack Univeristy Medical Center	Hackensack	New Jersey	07601	—
Memorial Sloan Kettering Cancer Center	New York	New York	10065	—
University Of North Carolina at Chapel Hill	Chapel Hill	North Carolina	27599	—
Ohio State University Comprehensive Cancer Center	Columbus	Ohio	43210	—
Prisma Health Cancer Institute	Greenville	South Carolina	29605	—
MD Anderson Cancer Center	Houston	Texas	77030	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 42 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04050436, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 27, 2025 · Synced Nov 12, 2026