Cancer Type: Cutaneous
Study Type: Treatment
Phase: Phase I/II
Principal Investigator: Zager, Jonathan
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.
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.
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