PV-10 Intralesional Injection vs Systemic Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
Phase: PHASE3
Conditions: Cutaneous Melanoma
Sponsor: Provectus Biopharmaceuticals, Inc.

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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