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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 27 February 2017
Main ID:  NCT02288897
Date of registration: 04/11/2014
Prospective Registration: Yes
Primary sponsor: Provectus Biopharmaceuticals, Inc.
Public title: PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
Scientific title: PV-10 Intralesional Injection vs Systemic Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
Date of first enrolment: April 2015
Target sample size: 225
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02288897
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Australia United States
Contacts
Name:     Eric Wachter, Ph.D.
Address: 
Telephone: +1 865 769 4011
Email: wachter@pvct.com
Affiliation: 
Name:     Eric Wachter, Ph.D.
Address: 
Telephone:
Email:
Affiliation:  Provectus Biopharmaceuticals, Inc.
Name:     Sanjiv Agarwala, M.D.
Address: 
Telephone:
Email:
Affiliation:  St Luke's University Hospital and Health Network
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age 18 years or older, male or female

2. Histologically or cytologically confirmed melanoma

3. Recurrent, satellite or in-transit locally advanced cutaneous or subcutaneous
melanoma metastases (i.e. AJCC Stage IIIB, IIIC or Stage IV M1a with no active nodal
metastases)

4. At least 1 cutaneous Target Lesion (each lesion > =10 mm in longest diameter or up to
5 lesions having a sum of longest diameters >= 10 mm). Target Lesions should be at
least 10 mm from any other lesion

5. No lesion > 30 mm in longest diameter; and no more than 50 lesions

6. Calculated required PV-10 dose = 15 mL (based on total tumor burden)

7. Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-2

8. Failed, did not tolerate, or not a candidate for treatment with at least one immune
checkpoint inhibitor (due to co-morbidities, pre-existing autoimmune disease, drug
unavailability or standard of care)

9. Failed, did not tolerate, or not a candidate for targeted therapy with BRAF or
combined BRAF/MEK inhibitors (i.e., BRAF V600 wild-type or due to drug unavailability
or standard of care)

10. Clinical Laboratories:

- Absolute neutrophil count (ANC) = 1.5 x 10^9/L and platelet count =100 x 10^9/L

- Creatinine = 3 times the upper limit of normal (ULN)

- Estimated creatinine clearance (CrCl) or estimated glomerular filtration rate
(eGFR) = 30 mL/min/1.73 m2

- Total bilirubin = 3 times the upper limit of normal (ULN)

- Aspartate transaminase (AST), alanine transaminase (ALT) and alkaline
phosphatase (ALP) = 5 times the upper limit of normal (ULN)

- Lactate dehydrogenase (LDH) = 2 times the upper limit of normal (ULN).

11. Thyroid function abnormality = Grade 2

12. Candidate for at least one comparator drug:

- Subjects must be candidates for at least one of the designated comparator drugs

Exclusion Criteria:

1. Presence or history of visceral melanoma metastasis

2. Presence of active nodal metastases (e.g., radiologic or clinical evidence of current
nodal disease)

3. Presence of more than 50 melanoma lesions

4. Radiation therapy to any Study Lesion within 6 weeks of initial study treatment.

5. 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

6. Immunotherapy for cancer within 4 weeks of initial study treatment

7. Local treatment (e.g., surgery, cryotherapy, laser ablation) to any Study Lesion
within 4 weeks of initial study treatment

8. Anti-tumor vaccine therapy within 6 weeks of initial study treatment.

9. Investigational agents within 4 weeks of initial study treatment.

10. Concurrent or Intercurrent Illness:

- Impaired wound healing or other extremity complications due to diabetes mellitus
in subjects whose Study Lesions are located in an extremity

- Severe peripheral vascular disease in subjects whose Study Lesions are located
in an extremity

- Significant concurrent or intercurrent illness, psychiatric disorders, or
alcohol or chemical dependence that would, in the opinion of the Investigator,
compromise the subject's safety or compliance or interfere with interpretation
of study results.

- Uncontrolled thyroid disease or cystic fibrosis

- Clinically significant acute or unstable cardiovascular, cerebrovascular
(stroke), renal, gastrointestinal, pulmonary, immunological, endocrine, or
central nervous system disorders

11. Pregnancy:

- Female subjects who are pregnant or lactating

- Female subjects who have positive serum pregnancy test taken within 14 days of
study treatment

- Female subjects of child-bearing potential who are not using effective
contraception (e.g., oral contraceptives, intrauterine devices, double barrier
methods such as condoms and diaphragms, abstinence or equivalent measures)

12. Contraindication for all comparators:

- Subjects with contraindications to all of the designated comparator drugs



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Melanoma Recurrent
Intervention(s)
Drug: Dacarbazine, temozolomide or talimogene laherparepvec
Drug: PV-10 (10% rose bengal disodium)
Primary Outcome(s)
Progression-free survival (PFS) [Time Frame: Assessed every 12 weeks up to 18 months]
Secondary Outcome(s)
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]
Number of participants with adverse events [Time Frame: Assessed every 4 weeks until 28 days after last treatment]
Overall survival (OS) [Time Frame: Assessed every 12 weeks up to 18 months]
Secondary ID(s)
PV-10-MM-31
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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