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

Official Title

A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination With RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

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.

Trial Description

Primary Outcome:

• Objective Response Rate (ORR) according to blinded independent review
• Complete Response Rate (CRR) according to blinded independent review

• Progression Free Survival (PFS) by blinded independent review.
• ORR/CRR by investigator assessment and blinded independent review
• ORR/CRR for patients with metastatic or locally advanced disease according to investigator review and blinded independent review
• ORR/CRR for patients who have and have not previously received systemic CSCC-directed therapy and blinded independent review
• Duration of Response (DOR) per investigator review and blinded independent review
• Progression-free Survival (PFS) per investigator review
• Overall Survival (OS)
• 3-year survival
• Change in overall scores of patient-reported outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
• Evaluation of the safety and tolerability of cemiplimab alone and combined with RP1 as assessed via adverse events (AEs)

View this trial on ClinicalTrials.gov