IRB #

STUDY00019285

Title

A Phase 1b/2 Study of PV-10 Intralesional Injection in Combination with Systemic Immune Checkpoint Inhibition for Treatment of Metastatic Melanoma

Principal Investigator

Dale Han

Study Purpose

The purpose of this study is to find out if an investigational drug called PV-10 given in combination with another drug called pembrolizumab can help people with metastatic melanoma.

Medical Condition(s)

Stage IV or unresectable stage III melanoma
At least 1 injectable lesion

Eligibility Criteria

Male and Female participants of 18 years of age and older.
Unresectable Stage III or Stage IV melanoma.

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

You will remain on the study until onset of disease progression, unmanageable toxicity or study termination by the Sponsor. You will be eligible to receive pembrolizumab for a maximum of 24 months while participating in this study. Afterwards, you will be contacted by the investigator or study team approximately every 12 weeks or more often to check on your health until end of the study. The estimated study duration is approximately 60 months.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Provectus Biopharmaceuticals, Inc.

Recruitment End

10/31/2020

Compensation Provided

No


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