PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

Conditions

• Carcinoma, Basal Cell

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• cemiplimab — DRUG
  Regimen as per protocol

Study Details

The primary objective is to estimate the objective response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when treated with cemiplimab as a monotherapy

Key Dates

Start date

Jun 29, 2017

Status verified

Apr 2025

Primary completion

May 20, 2021

Completion

Apr 27, 2023

Study Design

Enrollment

138 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1- metastatic BCC
  Administration of cemiplimab in accordance with protocol dosing regimen
• Experimental: Group 2 - unresectable locally advanced BCC
  Administration of cemiplimab in accordance with protocol dosing regimen

Primary Outcome Measure

Objective Response Rate (ORR) as Assessed by Independent Central Review (ICR) [ Time Frame: Up to 1422 days (approximately 46 months) ]

Locations (23)

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