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

Active:	No
Cancer Type:	Skin Cancer (Non-Melanoma) Unknown Primary	NCT ID:	NCT04050436
Trial Phases:	Phase II	Protocol IDs:	RPL-002-18 (primary) NCI-2019-06779
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Replimune Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04050436

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.

Objectives

RP1 is a selectively replication competent herpes simplex virus type 1(HSV-1). This is a
Phase 1/2, open-label, multicenter repeat-dosing study of RP1 alone and in combination with
nivolumab in patients with advanced malignancies, and contains both single agent dose
escalation, dose expansion to include nivolumab, and the combination in multiple Phase 2
cohorts in individual tumor types.

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