Melanoma Clinical Trial

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

Summary

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, or lung allograft transplantation 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.

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Full Description

RP1 is a genetically modified herpes simplex type 1 virus that is designed to directly destroy tumors and to generate an anti-tumor immune response. This is a Phase 1B/2, open label, multicenter, trial evaluating the objective response rate and the safety and tolerability, biodistribution, shedding, and preliminary efficacy of RP1 in adult hepatic, renal, heart and lung transplant recipients who subsequently experienced advanced or metastatic cutaneous malignanies. Patients will be dosed with RP1 by direct or ultrasound guided intra-tumoral injection into superficial, subcutaneous or nodal tumors. No transplanted organs will be injected.

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Eligibility Criteria

Key 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.
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

Patients must have progressed following local resection, prior radiation, topical or systemic therapies.

Documentation from the patient's transplant physician confirming that the patient's allograft is stable.

Patients for whom surgical or radiation treatment of lesions is contraindicated.
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).
Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
Anticipated life expectancy > 6 months
Baseline ECG without evidence of acute ischemia.
All patients must consent to provide archived or newly obtained tumor material (either formalin-fixed, paraffin-embedded [FFPE] block or 20 unstained slides).

Key Exclusion Criteria:

Prior treatment with an oncolytic therapy.
Patients with visceral metastases.
Patients with active herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis).
Patients with a history of organ graft rejection within 12 months.
Had systemic infection requiring intravenous (IV) antibiotics or anti-virals, or other serious infection within 60 days prior to dosing.
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.
Patients requiring CTLA-4-Ig medications.
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.
Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
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.
Patients with a condition requiring an increase in the patient's usual immunosuppressive medications within 60 days of study treatment.
Known active CNS metastases and/or carcinomatous meningitis.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

65

Study ID:

NCT04349436

Recruitment Status:

Recruiting

Sponsor:

Replimune Inc.

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There are 14 Locations for this study

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University of California, San Diego
La Jolla California, 92093, United States More Info
Gregory Daniels, MD
Principal Investigator
University of California, Los Angeles
Los Angeles California, 90024, United States More Info
Wanxing Chai-Ho, MD
Principal Investigator
UCSF, Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94143, United States More Info
Katy Tsai, MD
Principal Investigator
University of Colorado Cancer Center School of Medicine
Aurora Colorado, 80045, United States More Info
Theresa Medina, MD
Principal Investigator
University of Miami Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States More Info
Jennifer Tang
Principal Investigator
University of Chicago
Chicago Illinois, 60637, United States More Info
Diana Bolotin, MD
Principal Investigator
Columbia University Medical Center
New York New York, 10032, United States More Info
Shaheer Khan, DO
Principal Investigator
Rochester Dermatologic Surgery
New York New York, 14564, United States More Info
Ibrahim Sherrif
Contact
Duke University
Durham North Carolina, 27708, United States More Info
Meenal Kheterpal, MD
Principal Investigator
University of Cincinnati
Cincinnati Ohio, 45267, United States More Info
Trisha Wise-Draper, MD
Principal Investigator
The Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States More Info
Claire Verschraegen, MD
Principal Investigator
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15213, United States More Info
Jason Luke, MD
Principal Investigator
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Michael Migden, MD
Principal Investigator
VCU Massey Cancer Center
Richmond Virginia, 23298, United States More Info
Andrew Poklepovic, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

65

Study ID:

NCT04349436

Recruitment Status:

Recruiting

Sponsor:


Replimune Inc.

How clear is this clinincal trial information?

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