PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
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|ClinicalTrials.gov Identifier: NCT02288897|
Recruitment Status : Recruiting
First Posted : November 11, 2014
Last Update Posted : April 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous Melanoma||Drug: PV-10 (10% rose bengal disodium) Drug: Dacarbazine, temozolomide or talimogene laherparepvec||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||225 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Blinded review by independent review committee (IRC) for primary and key secondary endpoints.|
|Official Title:||PV-10 Intralesional Injection vs Systemic Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||October 2018|
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.
|Drug: PV-10 (10% rose bengal disodium)|
Active Comparator: Chemotherapy or Oncolytic Viral Therapy
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.
|Drug: Dacarbazine, temozolomide or talimogene laherparepvec|
- Progression-free survival (PFS) [ Time Frame: Assessed every 12 weeks up to 18 months ]
- Complete response rate (CRR) [ Time Frame: Assessed every 12 weeks up to 18 months ]
- Duration of complete response [ Time Frame: Assessed every 12 weeks up to 18 months ]
- Overall survival (OS) [ Time Frame: Assessed every 12 weeks up to 18 months ]
- Number of participants with adverse events [ Time Frame: Assessed every 4 weeks until 28 days after last treatment ]Safety and tolerability will be assessed by monitoring the frequency, duration, severity and attribution of adverse events and evaluating changes in laboratory values and vital signs.
- Change in domain scores from baseline using the patient reported Skindex-16 instrument [ Time Frame: Assessed 12 weeks after Day 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288897
|Contact: Eric Wachter, Ph.D.||+1 865 769 4011 ext email@example.com|
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|Study Director:||Eric Wachter, Ph.D.||Provectus Biopharmaceuticals, Inc.|
|Principal Investigator:||Sanjiv Agarwala, M.D.||St Luke's University Hospital and Health Network|