PV-10 in Combination With Pembrolizumab for Treatment of Metastatic Melanoma
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ClinicalTrials.gov Identifier: NCT02557321 |
Recruitment Status :
Active, not recruiting
First Posted : September 23, 2015
Last Update Posted : November 21, 2023
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Tracking Information | ||||
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First Submitted Date ICMJE | September 20, 2015 | |||
First Posted Date ICMJE | September 23, 2015 | |||
Last Update Posted Date | November 21, 2023 | |||
Actual Study Start Date ICMJE | October 2015 | |||
Actual Primary Completion Date | May 2023 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | PV-10 in Combination With Pembrolizumab for Treatment of Metastatic Melanoma | |||
Official Title ICMJE | A Phase 1b/2 Study of PV-10 Intralesional Injection in Combination With Systemic Immune Checkpoint Inhibition for Treatment of Metastatic Melanoma | |||
Brief 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). | |||
Detailed Description | Phase 1b. Up to 24 eligible subjects will be enrolled in an initial cohort in the Phase 1b portion of the study (Main Cohort). Up to an additional 24 eligible subjects who have failed to achieve a complete or partial response to or progressed on prior checkpoint inhibition will be enrolled in a first expansion cohort (Expansion Cohort 1). Up to an additional 24 eligible subjects with Stage III unresectable, in-transit or satellite melanoma will be enrolled in a second expansion cohort (Expansion Cohort 2). Each subject in each Phase 1b cohort will receive the combination of IL PV-10 and pembrolizumab. Phase 2. A total of an estimated 120 eligible subjects will be randomized in a 1:1 ratio to the two treatment arms (i.e., PV-10 + pembrolizumab or pembrolizumab alone) in the Phase 2 portion of the study. This number of subjects may be modified based on emerging evidence of preliminary efficacy and effect size from the Phase 1b and initial Phase 2 portions of the study. Subjects assigned to receive PV-10 in Phase 1b and 2 will receive initial IL PV-10 to their injectable lesions commencing on study Day 1 for up to 12 weeks (i.e., investigational Treatment Phase of the study). PV-10 may be re-administered at 21-day (3-week) intervals during the Treatment Phase of the study to any remaining, uninjected injectable lesions until all injectable lesions have been injected. Lesions that fail to exhibit complete ablation may be re-injected on this schedule. Pembrolizumab will be administered at 21-day (3-week) intervals per prescribing information (label) commencing on study Day 1 for up to 24 months or until disease progression, toxicity requiring discontinuation of study treatment or study termination. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Melanoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
50 | |||
Original Estimated Enrollment ICMJE |
144 | |||
Estimated Study Completion Date ICMJE | April 2025 | |||
Actual Primary Completion Date | May 2023 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | Australia | |||
Administrative Information | ||||
NCT Number ICMJE | NCT02557321 | |||
Other Study ID Numbers ICMJE | PV-10-MM-1201 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Provectus Pharmaceuticals ( Provectus Biopharmaceuticals, Inc. ) | |||
Original Responsible Party | Provectus Pharmaceuticals | |||
Current Study Sponsor ICMJE | Provectus Biopharmaceuticals, Inc. | |||
Original Study Sponsor ICMJE | Provectus Pharmaceuticals | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Provectus Pharmaceuticals | |||
Verification Date | November 2023 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |