- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06216938
RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis
Phase I Pilot Study of RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Danielle Bednarz, RN, BSN
- Phone Number: 412-623-1191
- Email: bednarzdl@upmc.edu
Study Contact Backup
- Name: Amy Rose, RN, BSN
- Phone Number: 412-647-8587
- Email: kennaj@upmc.edu
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- Recruiting
- UPMC Hillman Cancer Center
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Contact:
- Danielle Bednarz, RN, BSN
- Phone Number: 412-623-1191
- Email: bednarzdl@upmc.edu
-
Principal Investigator:
- Yana Najjar
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Contact:
- Amy Rose, RN, BSN
- Phone Number: 412-647-8587
- Email: kennaj@upmc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be willing and able to provide written informed consent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- Have a diagnosis of pT3b, T4a or T4b melanoma on biopsy. Patients must have grossly visible residual tumor, or a positive deep or lateral margin on initial biopsy. Patients with uveal melanoma are not eligible.
- Females of childbearing potential must have a negative beta-human chorionic gonadotropin (β-hCG) test with a minimum sensitivity of 25 IU/L or equivalent units of β-hCG during screening, before the first dose, and a negative urine pregnancy test on days of treatment (Day 1, 15 and 21). For serum and urine pregnancy tests and instructions (see Section 12.2).
- Female patients of reproductive potential must agree to avoid becoming pregnant and adhere to a highly effective contraception method until 90 days after last dose of RP1 alone. For a definition of highly effective contraceptive methods and instructions of patients and partners (see Section 12.2).
Male patients of reproductive potential must agree to avoid impregnating a partner and adhere to a highly effective contraception method until 90 days after last dose of RP1 study agent and refrain from donating sperm during this period. For a definition of highly effective contraceptive methods and instructions of patients and partners (see Section 12.2).
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Demonstrate adequate organ function. All screening labs should be performed within 30 days of treatment initiation. Baseline labs may be used as screening labs.
Exclusion Criteria:
- Prior treatment with an oncolytic virus therapy.
Has acute or chronic active hepatitis B and C virus infection or known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV) (defined as HCV RNA [qualitative]) or HIV infection.
Note: No testing for Hepatitis B, Hepatitis C, or HIV is required unless mandated by local health authority or clinically indicated.
- Had systemic infection requiring IV antibiotics or other serious infection within 14 days prior to dosing.
- Have active significant herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis).
- Conditions requiring treatment with immunosuppressive doses (> 10 mg daily prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy within 14 days after enrollment. For the definition of replacement therapy (Section 11.0 Supportive Care and Management of Adverse Reactions/Events).
- Major surgery ≤ 1 week prior to starting study drug. Note: Patients who undergo major surgery must adequately recover prior to starting study treatment.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within four weeks prior to the first dose of study treatment.
- History of documented allergic reactions or acute hypersensitivity reactions attributed to RP1 or any of its excipients.
Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacille Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed, however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
Note: Available COVID-19 vaccines do not contain live virus.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs or interfere with the patient's participation for the full duration of the study or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
- Has serious or uncontrolled medical disorders.
- Has known psychiatric, alcohol abuse, or substance abuse disorders that would interfere with cooperating with the requirements of the study.
- Is a person deprived of their liberty by a judicial or administrative decision, or an adult person subject to a legal protection measure.
- Is a solid organ transplant recipient.
- Has a concurrent malignancy requiring active systemic therapy or ongoing radiation.
- Patients with tumors that are located near critical structures, such as the carotid artery or portal vein, or scalp lesions presenting with moderate to extensive bone erosion and tumors that may have invaded the heart, great vessels, or other critical structures will not be eligible because these area should not be injected. Injection through an ulcerated area of a lesion should be avoided.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vusolimogene oderparepvec (RP1)
Patients will receive 3 doses of RP1 (1.0 mL/injection; 10e6 PFU/mL for the first dose, and 10e7 mL for the subsequent 2 doses).
The drug will be injected into the skin at the tumor biopsy site at baseline (day 1), day 15, and day 21, 4-5 weeks prior to SOC WLE and SLNB.
Definitive surgery will occur up to 28-35 (± 2 days) days from first injection, to avoid treatment delay.
|
Vusolimogene Oderparepvec is a genetically modified oncolytic viral strain of the herpes simplex type 1 (HSV-1) virus, with potential oncolytic, immunostimulating and antineoplastic activities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Sentinel Lymph Node (SLN) Positivity
Time Frame: Up to 2 years (cohort)
|
Proportion of patients with sentinel lymph node lymph node positivity (disease present in lymph node per pathologic assessment).
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Up to 2 years (cohort)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of all treatment-emergent adverse events (TEAEs)
Time Frame: Up to 2 years
|
Distinct number of patients that experience treatment-emergent adverse events (TEAEs) by highest grade per CTCAE v5.0.
|
Up to 2 years
|
Incidence of ≥ Grade 3 Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 2 years
|
Distinct number of patients that experience ≥ Grade 3 treatment-emergent adverse events (TEAEs) by highest grade per CTCAE v5.0.
|
Up to 2 years
|
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 2 years
|
Distinct number of distinct patients that experience Serious Adverse Events (SAEs) by highest grade per CTCAE v5.0.
|
Up to 2 years
|
Incidence of fatal Adverse Events (AEs)
Time Frame: Up to 2 years
|
Distinct number of patients that experience fatal Adverse Events (AEs) by highest grade per CTCAE v5.0.
|
Up to 2 years
|
Incidence of all treatment-emergent adverse events (TEAEs) requiring withdrawal from RP1
Time Frame: Up to 2 years
|
Distinct number of patients that experience treatment-emergent adverse events (TEAEs) requiring withdrawal from RP1 by highest grade per CTCAE v5.0.
|
Up to 2 years
|
Recurrence Free Survival (RFS)
Time Frame: Up to 3 years
|
Median number of months from start of treatment to recurrence of disease or death from any cause.
Recurrence of disease is defined as
|
Up to 3 years
|
Overall Survival (OS)
Time Frame: Up to 3 years
|
Median number of months from start of treatment until death from any cause.
|
Up to 3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yana Najjar, MD, UPMC Hillman Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCC 22-138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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