The Phase 2 study is a multicenter, open-label study of RP1 to further investigate safety and to estimate the efficacy of RP1 at the RP2D in combination with nivolumab in patients with Stage IIIb-IV unresectable melanoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, non-melanoma skin cancer (NMSC), and non-small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
340
Percentage of adverse events (AEs)
Percentage of subjects with adverse events (AEs)
Time frame: 26 months
Percentage of serious adverse events (SAEs)
Percentage of subjects with serious adverse events (SAEs)
Time frame: 26 months
Percentage of dose limiting toxicities (DLTs)
Percentage of subjects with dose limiting toxicities (DLTs)
Time frame: 26 months
Percentage of overall response rate (ORR)
Percentage of overall response rate (ORR) for all participants
Time frame: 26 months
Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1
Assess the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1 based on the safety and response data collected during Phase 1 Escalation
Time frame: 20 weeks
Percentage of biologic activity
Percentage of subjects with biological activity determined by tumor biopsies and biomarker data
Time frame: 20 weeks
Percentage subjects with detectable RP1
Data gathered from blood, urine, swabs of injection site, dressings, and oral mucosa to determine the shedding and biodistribution of RP1
Time frame: 20 weeks
Percentage of complete response (CR)
Percentage of subjects with a complete response (CR)
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University of Birmingham Alabama
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic
Phoenix, Arizona, United States
Carti Cancer Center
Little Rock, Arkansas, United States
UC San Diego
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
University of California- San Francisco
San Francisco, California, United States
Sylvester Comprehensive Cancer Center- University of Miami
Miami, Florida, United States
...and 41 more locations
Time frame: 26 months
Median duration of response
Median duration of response of subjects
Time frame: 26 months
Median progression-free survival
Median duration of progression-free survival of subjects
Time frame: 26 months
Median overall survival
Median overall survival rate of subjects
Time frame: 26 months