The purpose of this study is to assess the safety and efficacy of RP1 (administered into the tumor) in 90 patients who have received an organ transplant in the past and currently have skin cancer. The skin cancer is either locally advanced (large tumors in the skin, muscles or nerves) or metastatic (spread to other parts of the body). This study will consist of a 28-day Screening Period, a Treatment Period, and a Follow-up Period. During the Treatment Period, patients will be dosed with RP1 every two weeks for up to 2 years (104 weeks). Tumor measurements will be done approximately every 8 weeks (and additionally if needed) until progressive disease, start of subsequent anticancer therapy, or completion/discontinuation of the study. During the Follow-up Period, patients will visit the clinic at 30, 60, and 100-150 days after their last dose of RP1 for safety and quality of life assessments. Patients will continue follow-up for up to 3 years from the day of the last patient's first dose.
RP1 is a genetically modified herpes simplex type 1 virus that is designed to directly destroy tumors and to generate an anti-tumor immune response. This is a Phase 1B/2, open label, multicenter, study evaluating the objective response rate and the safety and tolerability of RP1 in adult hepatic, renal, heart, lung, other solid organs, and/or hematopoietic cell transplant recipients who subsequently experienced advanced or metastatic cutaneous malignancies. Patients will be dosed with RP1 by direct or ultrasound guided intra-tumoral injection into superficial, subcutaneous, or nodal tumors. No transplanted organs will be injected.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Genetically modified herpes simplex type 1 virus
Medical Dermatology Specialists
Phoenix, Arizona, United States
RECRUITINGMayo Clinic Arizona
Phoenix, Arizona, United States
RECRUITINGUniversity of California, San Diego
La Jolla, California, United States
RECRUITINGUniversity of California, Los Angeles
Los Angeles, California, United States
Primary Objective for Patients with Locally Advances CSCC (laCSCC)
The effect of RP1 on objective response rate (ORR) as assessed by Independnet Central Review (ICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Time frame: 36 months
Primary Efficacy Objective for Patients with Other Skin Cancers
The effect of RP1 on ORR as assessed by investigator review per modified RECIST 1.1 (mRECIST 1.1)
Time frame: 36 months
Primary Safety Objective for Patients with Other Skin Cancers
The safety and tolerability of single-agent RP1 in solid organ transplant patients with other skin cancers as assessed by incidence of patients with treatment-emergent adverse events (TEAEs) and by incidence of patients with biopsy-proven allograft rejection.
Time frame: 36 months
Duration of Response (DOR) for Patients with laCSCC
The effect of RP1 on the time from onset of response to disease progression (PD) or death in patients who achieve a Complete Response (CR) or Partial Response (PR) as assessed by ICR per RECIST 1.1
Time frame: 36 months
Progression-Free Survival (PFS) for Patients with laCSCC
The effect of RP1 on the time from the first study treatment to first evidence of disease progression or death as assessed by ICR per RECIST 1.1
Time frame: 36 months
Disease Control Rate (DCR) for Patients with laCSCC
The effect of RP1 on the proportion of patients achieving confirmed response (either CR or PR) or Stable Disease (SD) for at least 6 weeks as assessed by ICR per RECIST 1.1
Time frame: 36 months
ORR for Patients with laCSCC by investigator review
The effect of RP1 on the proportion of patients with confirmed best overall response of CR or PR as assessed by investigator review per RECIST 1.1
Time frame: 36 months
Efficacy parameters for Patients with laCSCC by investigator review
The effect of RP1 on DOR, PFS, and DCR as assessed by investigator review per RECIST 1.1
Time frame: 36 months
Overall Survival for Patients with laCSCC
The effect of RP1 on the time from first study treatment to death from any cause
Time frame: 36 months
Secondary Safety Objective for Patients with laCSCC
The safety and tolerability of single-agent RP1 in solid organ transplant patients with laCSCC as assessed by incidence of patients with TEAEs and by incidence of patients with biopsy-proven allograft rejection.
Time frame: 36 months
Secondary Objective for Patients with Other Skin Cancers
The effect of RP1 on DOR and PFS as assessed by investigator review per mRECIST 1.1. The effect of RP1 on OS.
Time frame: 36 months
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UCSF, Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
RECRUITINGUniversity of Colorado Cancer Center School of Medicine
Aurora, Colorado, United States
RECRUITINGMayo Clinic Florida
Jacksonville, Florida, United States
RECRUITINGUniversity of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGUniversity of Chicago
Chicago, Illinois, United States
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