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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
231
Cemiplimab administered intravenously
RP1 administered intratumorally
Objective Response Rate (ORR) according to blinded independent review
Time frame: up to 5 years
Complete Response Rate (CRR) according to blinded independent review
Time frame: up to 5 years
Progression Free Survival (PFS) by blinded independent review.
Time frame: up to 5 years
ORR/CRR by investigator assessment and blinded independent review
Time frame: up to 5 years
ORR/CRR for patients with metastatic or locally advanced disease according to investigator review and blinded independent review
Time frame: up to 5 years
ORR/CRR for patients who have and have not previously received systemic CSCC-directed therapy and blinded independent review
Time frame: up to 5 years
Duration of Response (DOR) per investigator review and blinded independent review
Time frame: up to 5 years
Progression-free Survival (PFS) per investigator review
Time frame: up to 5 years
Overall Survival (OS)
Time frame: up to 5 years
3-year survival
Time frame: 3 years
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)
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University of California San Diego
La Jolla, California, United States
University of California Los Angeles
Los Angeles, California, United States
Stanford University
Stanford, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
University of Miami Health System
Miami, Florida, United States
Orlando Health UF Health Cancer Center
Orlando, Florida, United States
Moffitt McKinley Outpatient Center
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
John Theurer Cancer Center at Hackensack Univeristy Medical Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
...and 46 more locations
Time frame: approximately 30 months
Evaluation of the safety and tolerability of cemiplimab alone and combined with RP1 as assessed via adverse events (AEs)
Time frame: approximately 26 months