Recent Updates
Recently added Catalysts

Cemiplimab

Phase 2

Cutaneous Squamous Cell Carcinoma | Small molecule | Oncology |Replimune Group, Inc.|Last Updated: Jan 27, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment231
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04050436Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin CancerPHASE2 ACTIVE NOT_RECRUITING 231Oct 8, 2019Sep 1, 2025Jan 27, 202556 United States, Australia +8
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Objective Response Rate (ORR) according to blinded independent review
up to 5 years
Complete Response Rate (CRR) according to blinded independent review
up to 5 years
Secondary Endpoints
Progression Free Survival (PFS) by blinded independent review.
up to 5 years
ORR/CRR by investigator assessment and blinded independent review
up to 5 years
ORR/CRR for patients with metastatic or locally advanced disease according to investigator review and blinded independent review
up to 5 years
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cemiplimab in combination with RP1EXPERIMENTALCemiplimab administered intravenously every 3 weeks in combination with RP1 administered as an intratumoral injection every 3 weeks
CemiplimabACTIVE_COMPARATORCemiplimab administered intravenously as a single therapy every 3 weeks
Interventions
NameTypeDescription
CemiplimabDRUGCemiplimab administered intravenously
RP1BIOLOGICALRP1 administered intratumorally
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites56

Key Inclusion Criteria: * Histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma * Patients with locally advanced disease who are not suitable candidates for surgical or radiological treatment of lesions or have refused those treatments * At least 1 lesion that is...

Countries:United StatesAustraliaBulgariaCanadaFranceGermanyGreeceItalyPolandSpain
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04050436primaryCompletionDate: changed
LOWMay 24, 2026NCT04050436studyFirstPostDate: changed