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Cemiplimab

Phase 2

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

Target and mechanism

Molecular targetPDCD1
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment231

FDA Designations

No designations recorded

Clinical trial landscape

Cemiplimab · 1 trial · 3 indications

Phase 2 1
NCT04050436Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin CancerCutaneous Squamous Cell Carcinoma
ACTIVE NOT_RECRUITING231 Analytics
PHASE2ACTIVE NOT_RECRUITING
Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
Cutaneous Squamous Cell CarcinomaUnlock trial analytics

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
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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
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about Cemiplimab

What is Cemiplimab used for in Cutaneous Squamous Cell Carcinoma?

Cemiplimab is being studied for the treatment of Cutaneous Squamous Cell Carcinoma, including advanced and metastatic forms of the disease. It is an investigational therapy currently in Phase 2 clinical development for this indication.

What does Cemiplimab target?

Cemiplimab is a monoclonal antibody, classified as a -mab (antibody) modality. It is being evaluated in combination with another agent for the treatment of advanced squamous skin cancer.

Who is developing Cemiplimab?

Cemiplimab is being developed by Replimune Group, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol REPL.

What phase is Cemiplimab in?

Cemiplimab is in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities.

What clinical trials is Cemiplimab in?

Cemiplimab is being studied in a Phase 2 clinical trial with the identifier NCT04050436. This trial evaluates Cemiplimab alone and in combination with RP1 in treating advanced squamous skin cancer, with an enrollment of 231 participants.

Is Cemiplimab being studied in a randomized controlled trial?

Yes, the Phase 2 trial of Cemiplimab is randomized and active-controlled. The study is not double-blinded and does not use a biomarker-selected patient population.