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

Part of paid clinical trials in La Jolla, California.

Sponsor
Replimune, Inc.
Study ID
NCT04050436
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    Cemiplimab administered intravenously
  • RP1 — BIOLOGICAL
    RP1 administered intratumorally

Study Details

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.

Key Dates

Start date
Oct 8, 2019
Status verified
Jan 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
231 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cemiplimab in combination with RP1
    Cemiplimab administered intravenously every 3 weeks in combination with RP1 administered as an intratumoral injection every 3 weeks
  • Active Comparator: Cemiplimab
    Cemiplimab administered intravenously as a single therapy every 3 weeks

Primary Outcome Measure

Objective Response Rate (ORR) according to blinded independent review [ Time Frame: up to 5 years ]

Locations (14)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92093-
University of California Los AngelesLos AngelesCalifornia90024-
Stanford UniversityStanfordCalifornia94305-
University of Colorado Cancer CenterAuroraColorado80045-
University of Miami Health SystemMiamiFlorida33136-
Orlando Health UF Health Cancer CenterOrlandoFlorida32806-
Moffitt McKinley Outpatient CenterTampaFlorida33612-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
John Theurer Cancer Center at Hackensack Univeristy Medical CenterHackensackNew Jersey07601-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University Of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Prisma Health Cancer InstituteGreenvilleSouth Carolina29605-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in La Jolla, CA

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
University of California San Diego· La Jolla, CAUniversity of California Los Angeles· Los Angeles, CAStanford University· Stanford, CAUniversity of Colorado Cancer Center· Aurora, COUniversity of Miami Health System· Miami, FLOrlando Health UF Health Cancer Center· Orlando, FL

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