RECRUITING

A Phase 1B/2 Study of RP1 in Solid Organ Transplant Patients With Advanced Cutaneous Malignancies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This Phase 1B/2 study is a multicenter, open-label, study of RP1 to investigate the (a) objective response rate, in addition to (b) safety and tolerability of RP1 for the treatment of advanced cutaneous malignancies in up to 65 evaluable organ transplant recipients. This will include patients with either previous renal, hepatic, heart, lung, or other solid organ transplantation or hematopoietic cell transplant and experiencing subsequent documented locally advanced or metastatic cutaneous malignancies. The study will enroll a total of 65 evaluable patients. Patients will participate up to approximately 3 years including a 28-day screening period, up to approximately 1 year treatment period, and a 2-year follow-up period.

Official Title

An Open-Label, Multicenter, Phase 1B/2 Study of RP1 in Solid Organ and Hematopoietic Cell Transplant Recipients With Advanced Cutaneous Malignancies

Quick Facts

Study Start:2020-05-15
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04349436

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 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.
  2. 2. Patients with histologically or cytologically confirmed recurrent, locally advanced or metastatic (to skin, soft tissue or lymph nodes) cutaneous malignancies, including CSCC, basal cell carcinoma, Merkel cell carcinoma, and melanoma
  3. 3. Patients must have progressed following local resection, prior radiation, topical or systemic therapies.
  4. 4. Documentation from the patient's transplant physician confirming that the patient's allograft is stable.
  5. 5. Patients for whom surgical or radiation treatment of lesions is contraindicated.
  6. 6. At least 1 lesion that is measurable and injectable by study criteria (tumor of ≥1cm in longest diameter or ≥1.5 cm in shortest diameter for lymph nodes).
  7. 7. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
  8. 8. Anticipated life expectancy \> 6 months
  9. 9. Baseline ECG without evidence of acute ischemia.
  10. 10. All patients must consent to provide archived or newly obtained tumor material (either formalin-fixed, paraffin-embedded \[FFPE\] block or 20 unstained slides).
  1. 1. Prior treatment with an oncolytic therapy.
  2. 2. Patients with visceral metastases.
  3. 3. Patients with active herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis).
  4. 4. Patients with a history of organ graft rejection within 12 months.
  5. 5. Had systemic infection requiring intravenous (IV) antibiotics or anti-virals, or other serious infection within 60 days prior to dosing.
  6. 6. Patients who require intermittent or chronic use of systemic (oral or intravenous) anti-virals with known anti-herpetic activity (e.g., acyclovir) unless for organ allograft preservation.
  7. 7. Patients requiring CTLA-4-Ig medications.
  8. 8. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments beyond that required for maintenance allograft rejection prevention. The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that requires only hormone replacement, or psoriasis that does not require systemic treatment.
  9. 9. Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
  10. 10. Any history of transplant-related viral infections, such as BKV, EBV or CMV, within 3 months of study entry. Patients with a history of hepatitis B or C virus must have undetectable viral load within 3 months of study entry.
  11. 11. Patients with a condition requiring an increase in the patient's usual immunosuppressive medications within 60 days of study treatment.
  12. 12. Known active CNS metastases and/or carcinomatous meningitis.

Contacts and Locations

Study Contact

Clinical Trials at Replimune
CONTACT
1-781-222-9570
Clinicaltrials@replimune.com

Principal Investigator

May Cho, MD
STUDY_DIRECTOR
Replimune Inc.

Study Locations (Sites)

Medical Dermatology Specialists
Phoenix, Arizona, 85006
United States
University of California, San Diego
La Jolla, California, 92093
United States
University of California, Los Angeles
Los Angeles, California, 90024
United States
UCSF, Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
United States
University of Colorado Cancer Center School of Medicine
Aurora, Colorado, 80045
United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
University of Chicago
Chicago, Illinois, 60637
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Columbia University Medical Center
New York, New York, 10032
United States
Rochester Dermatologic Surgery
New York, New York, 14564
United States
Duke University
Durham, North Carolina, 27708
United States
University of Cincinnati
Cincinnati, Ohio, 45267
United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
VCU Massey Cancer Center
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Replimune Inc.

  • May Cho, MD, STUDY_DIRECTOR, Replimune Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-05-15
Study Completion Date2028-01

Study Record Updates

Study Start Date2020-05-15
Study Completion Date2028-01

Terms related to this study

Additional Relevant MeSH Terms

  • Cutaneous Squamous Cell Carcinoma
  • Merkel Cell Carcinoma
  • Basal Cell Carcinoma
  • Melanoma