Study on RP1 for Organ Transplant Patients with Advanced Skin Cancers

Sponsor: Replimune Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04349436

Provider View

This clinical trial is testing a new treatment called RP1, a modified virus, to see if it can help treat advanced skin cancers in patients who have had organ transplants. The study will also check if the treatment is safe and well-tolerated.

Patient Parameters

Program Overview

This study is exploring the use of RP1, a genetically modified virus, to treat advanced skin cancers in patients who have received organ transplants, such as kidney, liver, heart, or lung transplants. The trial will involve up to 65 patients and will last about three years, including a screening period, treatment period, and follow-up. The main goals are to see how well the treatment works in shrinking tumors and to ensure it is safe for patients.

Description

RP1 is a specially designed virus that aims to destroy cancer cells and boost the body's immune response against tumors. This study will test RP1 in patients who have had organ transplants and now have advanced skin cancers. The treatment involves injecting RP1 directly into the tumors using a needle, guided by ultrasound if needed. The study will not involve injecting any transplanted organs.

The trial will take place at multiple centers and will be open-label, meaning both the researchers and participants will know what treatment is being given. The study will focus on how well the treatment works in reducing tumors and its safety, including how the virus spreads in the body and any side effects. Participants will be monitored closely throughout the study.

Eligibility Criteria

Inclusion Criteria

  • Willing to provide written consent and follow study procedures.
  • Have confirmed advanced skin cancer that has returned or spread, including types like squamous cell carcinoma, basal cell carcinoma, Merkel cell carcinoma, and melanoma.
  • Cancer has not responded to previous treatments like surgery, radiation, or medication.
  • Stable organ transplant, confirmed by a transplant doctor.
  • Surgery or radiation is not an option for treating the cancer.
  • Have at least one tumor that can be measured and injected.
  • Good overall health with a performance status of 0 or 1.
  • Expected to live more than 6 months.
  • Normal heart function on an ECG test.
  • Agree to provide a sample of the tumor for study purposes.

Exclusion Criteria

  • Have had previous treatment with a similar oncolytic therapy.
  • Cancer has spread to internal organs.
  • Have active herpes infections or past complications from herpes.
  • History of organ rejection in the past year.
  • Recent serious infections requiring IV antibiotics or antivirals.
  • Need for regular antiviral medications, unless for transplant maintenance.
  • Require CTLA-4-Ig medications.
  • Have significant autoimmune diseases needing treatment beyond transplant medications.
  • Active infections with hepatitis B, C, or HIV.
  • History of certain viral infections related to transplants within 3 months.
  • Need for increased immunosuppressive medication recently.
  • Active cancer spread to the brain or spinal fluid.

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