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

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.

Conditions

Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, Basal Cell Carcinoma, Melanoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Cutaneous Squamous Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Phoenix

Medical Dermatology Specialists, Phoenix, Arizona, United States, 85006

La Jolla

University of California, San Diego, La Jolla, California, United States, 92093

Los Angeles

University of California, Los Angeles, Los Angeles, California, United States, 90024

San Francisco

UCSF, Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States, 94143

Aurora

University of Colorado Cancer Center School of Medicine, Aurora, Colorado, United States, 80045

Miami

University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States, 33136

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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. 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. Patients must have progressed following local resection, prior radiation, topical or systemic therapies.
  • 4. Documentation from the patient's transplant physician confirming that the patient's allograft is stable.
  • 5. Patients for whom surgical or radiation treatment of lesions is contraindicated.
  • 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. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
  • 8. Anticipated life expectancy \> 6 months
  • 9. Baseline ECG without evidence of acute ischemia.
  • 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. Prior treatment with an oncolytic therapy.
  • 2. Patients with visceral metastases.
  • 3. Patients with active herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis).
  • 4. Patients with a history of organ graft rejection within 12 months.
  • 5. Had systemic infection requiring intravenous (IV) antibiotics or anti-virals, or other serious infection within 60 days prior to dosing.
  • 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. Patients requiring CTLA-4-Ig medications.
  • 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. Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
  • 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. Patients with a condition requiring an increase in the patient's usual immunosuppressive medications within 60 days of study treatment.
  • 12. Known active CNS metastases and/or carcinomatous meningitis.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Replimune Inc.,

May Cho, MD, STUDY_DIRECTOR, Replimune Inc.

Study Record Dates

2028-01