A Phase 1B/2 Study of RP1 in Solid Organ Transplant Patients With Advanced Cutaneous Malignancies
NCT ID: NCT04349436
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
65 participants
INTERVENTIONAL
2020-05-15
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RP1, intra-tumoral injection, oncolytic virus
RP1 administered as an intra-tumoral injection every 2 weeks.
RP1, intra-tumoral injection, oncolytic virus
Genetically modified herpes simplex type 1 virus
Interventions
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RP1, intra-tumoral injection, oncolytic virus
Genetically modified herpes simplex type 1 virus
Eligibility Criteria
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Inclusion Criteria
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).
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Replimune Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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May Cho, MD
Role: STUDY_DIRECTOR
Replimune Inc.
Locations
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Medical Dermatology Specialists
Phoenix, Arizona, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
University of California, San Diego
La Jolla, California, United States
University of California, Los Angeles
Los Angeles, California, United States
UCSF, Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
University of Colorado Cancer Center School of Medicine
Aurora, Colorado, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Chicago
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Rochester Dermatologic Surgery
New York, New York, United States
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Tennessee Medical Center at Knoxville
Knoxville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
VCU Massey Cancer Center
Richmond, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Other Identifiers
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RPL-003-19
Identifier Type: -
Identifier Source: org_study_id
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