PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Mela… (NCT02288897) | Clinical Trial Compass
TerminatedPhase 3
PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
Stopped: Inadequate rate of enrollment
United States20 participantsStarted 2015-04
Plain-language summary
This is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy or intralesional oncolytic viral therapy to assess treatment of locally advanced cutaneous melanoma in patients who (1) are not candidates for targeted therapy and (2) are not candidates for an immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine (DTIC), temozolomide (TMZ) or intralesional talimogene laherparepvec as determined by Investigator preference and standard of care in the Investigator's country or region. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18 years or older, male or female
✓. Histologically or cytologically confirmed melanoma
✓. Recurrent, satellite or in-transit locally advanced cutaneous or subcutaneous melanoma metastases (i.e., American Joint Committee on Cancer (AJCC) Stage IIIB, IIIC or Stage IV M1a with no active nodal metastases)
✓. At least 1 measurable Target Lesion that can be accurately measured by calipers or computed tomography (CT) consisting of:
✓. No lesion \> 50 mm in longest diameter; and no more than 50 lesions
✓. Calculated required PV-10 dose ≤ 15 mL (based on total tumor burden)
✓. Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-2
✓. Not a candidate for treatment with an immune checkpoint inhibitor (e.g., failed or did not tolerate prior therapy, or due to co-morbidities, pre-existing autoimmune disease, drug unavailability or standard of care)
Exclusion criteria
What they're measuring
1
Progression-free Survival (PFS)
Timeframe: Assessed every 12 weeks until disease progression, withdrawal of consent, or study termination; progression detected between formal assessments was documented at the time of detection; median follow-up time for PFS was 26.6 weeks, maximum was 125.8 weeks.
. Presence or history of visceral melanoma metastasis
✕. Presence of active nodal metastases (e.g., radiologic or clinical evidence of current nodal disease)
✕. Presence of more than 50 melanoma lesions
✕. Radiation therapy to any Study Lesion within 6 weeks of initial study treatment.
✕. Chemotherapy or other systemic cancer therapy within 4 weeks of initial study treatment (6 weeks for nitrosoureas or mitomycin), or regional chemotherapy (limb infusion or perfusion) within 12 weeks of initial study treatment
✕. Immunotherapy for cancer within 4 weeks of initial study treatment
✕. Local treatment (e.g., surgery, cryotherapy, laser ablation) to any Study Lesion within 4 weeks of initial study treatment
✕. Anti-tumor vaccine therapy within 6 weeks of initial study treatment.