Conditions: Cutaneous Melanoma
Keywords: Stage III Stage IIIB Stage IIIC Stage IV (M1a) Stage 3 Stage 4 IVM1a IV(M1a) IV-M1a in-transit in transit intransit satellite recurrent
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: no

Brief 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.

Detailed description:
Subjects will be randomized using a 2:1 treatment allocation (i.e. two-thirds of the subjects will receive PV-10).

Subjects in the comparator arm who have completed at least 1 cycle of study treatment and who meet the study protocol definition of disease progression but do not have evidence of visceral metastases will be eligible to enter the crossover portion of the study and receive PV-10. Subjects crossing over must meet all study inclusion and exclusion criteria for clinical laboratories, thyroid function, concurrent or intercurrent illness and pregnancy at the time of crossover.

Assessment of progression will be performed by an Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) ver. 1.1 criteria. Events signaling progression include increase in size and/or number of lesions, distant or nodal disease progression, or death. All secondary endpoints involving disease response and progression will be based on the IRC determination.

An interim assessment of efficacy and safety will be performed by the IRC when 50% of the events required for the primary endpoint have occurred.

Arms:
arm 1: Subjects will receive intralesional PV-10 to all Study Lesions on study Day 1. PV-10 should be re-administered at 28-day intervals until complete response, disease progression or study termination occurs. arm 2: Subjects will receive (a) dacarbazine (intravenously at 850 m/m2) or temozolomide (orally at 200 mg/m2 daily for 5 consecutive days), administered at consecutive 28-day intervals, or (b) intralesional talimogene laherparepvec administered on an initial 21 interval followed by consecutive 14 day intervals, until complete response, disease progression or study termination occurs.

Interventions: intervention 1: PV-10 (10% rose bengal disodium) intervention 2: Dacarbazine, temozolomide or talimogene laherparepvec
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document:
Prot_SAP_000.pdf: 
Provectus  
Protocol PV-10-MM-31 
 
Biopharmaceuticals, Inc. 
 
 
 
 
 
 
Study Protocol and Statistical Analysis Plan Cover Page 
 
 
 
 
TITLE 
PV-10 Intralesional Injection vs Systemic Chemotherapy or 
Intralesional Oncolytic Viral Therapy for Treatment of 
Locally Advanced Cutaneous Melanoma  
PROTOCOL NO 
PV-10-MM-31 
IND NO 
70539 
NCT NO 
NCT02288897 
EudraCT NO 
2016-000317-78 
INVESTIGATIONAL  
DRUG 
PV-10  
(10% w/v rose bengal disodium in 0.9% saline for injection) 
DOSAGE FORM 
Intralesional Injection 
SPONSOR 
Provectus Biopharmaceuticals, Inc. 
10025 Investment Drive, Suite 250 
Knoxville, TN 37932 USA 
DATE 
27 Mar 2018 
 
Due to slow accrual during a period of rapidly changing trends in global drug development 
for cutaneous melanoma, the study was terminated early and no Statistical Analysis Plan was 
implemented. Please refer to protocol section 10 for statistical and analytical considerations. 


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