RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis
ConditionMelanoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorYana Najjar
About this trial
This early-phase study will examine Vusolimogene Oderparepvec, a genetically modified oncolytic viral strain of the herpes simplex type 1 (HSV-1) virus, with potential oncolytic, immunostimulating and antineoplastic activities. Upon administration, vusolimogene oderparepvec specifically targets, infects and replicates in tumor cells and does not infect healthy cells. This results in tumor cell lysis and the release of virus particles which infect and replicate within nearby tumor cells, resulting in tumor cel death. The immune system is activated by the released tumor-associated antigens (TAAs) from the tumor cells creating an anti-tumor immune response against the tumor cells, thereby further killing the tumor cells. The virus itself also elicits a tumor-specific systemic immune and cytotoxic T-lymphocyte (CTL) response, thereby killing nearby non-infected tumor cells.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
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).
Trial design
Design model
Single group
Treatments tested in this trial
Vusolimogene oderparepvec (RP1)
Biological/VaccineVusolimogene Oderparepvec is a genetically modified oncolytic viral strain of the herpes simplex type 1 (HSV-1) virus, with potential oncolytic, immunostimulating and antineoplastic activities.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Vusolimogene oderparepvec (RP1)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of Sentinel Lymph Node (SLN) Positivity
Proportion of patients with sentinel lymph node lymph node positivity (disease present in lymph node per pathologic assessment).
Time frame
Up to 2 years (cohort)Secondary outcomes
1
Incidence of all treatment-emergent adverse events (TEAEs)
Distinct number of patients that experience treatment-emergent adverse events (TEAEs) by highest grade per CTCAE v5.0.
Time frame
Up to 2 years2
Incidence of ≥ Grade 3 Treatment Emergent Adverse Events (TEAEs)
Distinct number of patients that experience ≥ Grade 3 treatment-emergent adverse events (TEAEs) by highest grade per CTCAE v5.0.
Time frame
Up to 2 years3
Incidence of Serious Adverse Events (SAEs)
Distinct number of distinct patients that experience Serious Adverse Events (SAEs) by highest grade per CTCAE v5.0.
Time frame
Up to 2 years4
Incidence of fatal Adverse Events (AEs)
Distinct number of patients that experience fatal Adverse Events (AEs) by highest grade per CTCAE v5.0.
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov