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Norris Cotton Cancer Center
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A Phase 1b/2 Study of PV-10 Intralesional Injection in Combination with Systemic Immune Checkpoint Inhibition for Treatment of Metastatic Melanoma
Principal Investigator (?)
Study Number
F17035
Summary
This is an international multicenter, open-label, sequential phase study of intralesional (IL) PV-10 in combination with immune checkpoint inhibition. Metastatic melanoma patients (Stage IV or Stage III unresectable, in-transit or satellite disease) with at least one injectable lesion who are candidates for pembrolizumab (both treatment naïve patients and treatment refractory patients who have failed to achieve a complete or partial response to or previously progressed on one or more checkpoint inhibitor) will be eligible for study participation. In the Phase 1b portion of the study, all participants will receive the combination of IL PV-10 and pembrolizumab (i.e., PV-10 + standard of care). In the subsequent Phase 2 portion of the study participants will be randomized 1:1 to receive either the combination of IL PV-10 and pembrolizumab or pembrolizumab alone (i.e., PV-10 + standard of care vs. standard of care). 
Phase (?)
Phase III
Sponsor (?)
Available at the following location(s)

Lebanon

View more details from ClinicalTrials.gov.

Contact Information

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Please Note: Any eligibility criteria noted are subject to change. Our research nurses can provide you with the most current eligibility and exclusion criteria. Any study involvement to be undertaken must ultimately be determined on an individual basis.

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