Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and … (NCT04349436) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies
United States69 participantsStarted 2020-05-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntary agreement to provide written informed consent prior to any study procedures and the willingness and ability to comply with all aspects of the protocol and understand the risk to their organ allograft.
✓. Male or female at birth and at least 18 years of age prior to signing informed consent.
✓. Solid organ or allogeneic hematopoietic cell transplant patients with histologically or cytologically confirmed recurrent, cutaneous malignancies including locally advanced CSCC, metastatic (to skin, soft tissue, or lymph nodes) or locally advanced BCC, metastatic or locally advanced MCC, and melanoma.
✓. Patients must have progressed or experienced recurrence from previous local resection and/or prior radiation.
✓. Documentation from the patient's transplant physician confirming that the patient's allograft is stable. For dual transplant recipients, a failure of 1 of the transplanted organs is allowed.
✓. Patients for whom surgical or radiation treatment of lesions is contraindicated or are considered to be inoperable.
✓. Patients must have at least 1 measurable tumor of at least 1 cm in longest diameter. All measurable lesions identified at screening must be injectable and planned to be injected during the course of the study.
✓
What they're measuring
1
Primary Objective for Patients with Locally Advances CSCC (laCSCC)
Timeframe: 36 months
2
Primary Efficacy Objective for Patients with Other Skin Cancers
Timeframe: 36 months
3
Primary Safety Objective for Patients with Other Skin Cancers
✕. Prior treatment with an oncolytic therapy or checkpoint inhibitor.
✕. Patients with visceral metastases.
✕. Active significant herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis). Patients requiring use of systemic (oral/intravenous \[IV\]) antiviral agents with known antiherpetic activity.
✕. Had systemic infection requiring IV antibiotics or other serious infection within 14 days prior to dosing.
✕. Patients with an active, known, or suspected autoimmune disease that requires systemic immunosuppressive treatment beyond immunosuppressive medications required for maintenance of allograft rejection prevention.
✕. Patients with a history of any positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating the presence of the virus, or human immunodeficiency virus (HIV) positive. Patients with a history of HBV or HCV must have undetectable viral load within 3 months of study entry.
✕. A history of transplant-related viral infections such as BK virus (BKV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) requiring treatment or modification to immunosuppression within 3 months of study entry.