A Phase 1b/2 Study of PV-10 Intralesional Injection in Combination with Systemic Immune Checkpoint Inhibition for Treatment of Metastatic Melanoma
The purpose of this study is to find out if an investigational drug called PV-10, given in combination with another drug called pembrolizumab (also called Keytruda®) can help people with melanoma.
The primary objective of the initial, single-arm Phase 1b portion of the study, is to assess safety and preliminary efficacy (objective response rate and progression free survival) of the combination (i.e., PV-10 + pembrolizumab) in treating metastatic melanoma. Potential immunomodulatory impact of study treatment will also be assessed.
Immunotherapy; Therapy (NOS)
PV-10 (); Pembrolizumab (Keytruda)
> Age 18 years or older, male or female.
> Untreated or clinically active melanoma brain metastases. Potential participants with ≤ 3 brain metastases and each ≤ 1 cm size that were treated with either surgical resection and/or radiation therapy are eligible for study participation provided: (a) there is no evidence of progressive central nervous system (CNS) disease on brain imaging at least 30 days after definitive treatment and (b) the subject is not taking prednisone at >10 mg or equivalent daily. Potential participants > 1 cm or > 3 in number treated brain metastases are eligible for study participation provided: (a) there is no evidence of progressive CNS disease on brain imaging at least 90 days after treatment with surgery and/or radiation therapy and (b) if the patient is not taking prednisone at >10 mg or equivalent daily.
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