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

NCT04050436 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2025-01-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Cemiplimab

Cemiplimab administered intravenously

BIOLOGICAL

RP1

RP1 administered intratumorally

Sponsors & Collaborators

Principal Investigators

  • Moran Mishal, MD · Lead Medical Monitor

  • Jeannie Hou, MD · Secondary Medical Monitor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-08
Primary Completion
2025-09-30
Completion
2025-09-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04050436 on ClinicalTrials.gov