Trial of pIL-12/MK-3475 in Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT02493361|
Recruitment Status : Completed
First Posted : July 9, 2015
Results First Posted : August 21, 2019
Last Update Posted : June 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Pembrolizumab Drug: pIL-12||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Phase II, Multicenter Study of Enhancing Pembrolizumab Responses in Melanoma Through Intratumoral pIL-12 Electroporation|
|Actual Study Start Date :||August 17, 2015|
|Actual Primary Completion Date :||April 26, 2018|
|Actual Study Completion Date :||March 2, 2020|
Pembrolizumab: 200 mg IV, Day 1 of each cycle pIL-12: 1/4 tumor volume at concentration of 0.5 mg/mL intratumoral, Days 1, 5, and 8 of each odd cycle
- Best Overall Objective Response Rate (ORR) Within 24 Weeks Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to week 24 ]
Best overall ORR within 24 weeks of first treatment with pIL-12 electroporation (EP) and pembrolizumab will be determined using RECIST v1.1 by investigator evaluation
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions determined by 2 separate scans conducted not < 4 weeks apart and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (the sum may not be "0" if there are target nodes) and no appearance of new lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no appearance of new lesions. ORR = CR + PR.
- Number of Participants With Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: From enrollment through 30 days after end of treatment, an average of 2 years ]Analyses will be performed for all patients having received at least one dose of study drug. The study will use the CTCAE v4.0 for reporting of adverse events.
- Duration of Response (DOR) Assessed by RECIST v1.1 [ Time Frame: From treatment initiation until disease progression, start of new treatment, or end of study, whichever occurs first, about 5 years ]DOR for those experiencing CR or PR is the number of days from the initial documentation of an objective response to the most current evaluation of that response (censored duration) or to documentation of progression. Response determinations are assessed by RECIST v1.1.
- Twenty-Four Week Landmark Progression Free Survival (PFS) Assessed by RECIST v1.1 [ Time Frame: At 24 weeks after treatment initiation ]Twenty-four week landmark PFS (PFS at 24) is defined as the percentage of patients, who have progressed at the 24 week time point. Tumor response determinations were assessed by RECIST v1.1.
- Median PFS Assessed by RECIST v1.1 [ Time Frame: From treatment initiation until disease progression, start of new treatment, or end of study, whichever occurs first, about 5 years ]PFS is defined as the duration between the date of treatment initiation to the first date of either disease progression or death. Tumor response determinations were assessed by RECIST v1.1.
- Overall Survival (OS) [ Time Frame: From treatment initiation until death or end of the study, whichever occurs first, about 5 years ]OS is defined as the duration between the date of treatment initiation to the date of death, regardless of the cause of death.
- Best Overall ORR Determined by Immune Related- Response Criteria (irRC) [ Time Frame: From treatment initiation until disease progression, start of new treatment, or end of study, whichever occurs first, about 5 years ]Best overall objective response rate, CR + PR, as determined by irRC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493361
|United States, California|
|University of San Francisco, California|
|San Francisco, California, United States, 94115|
|United States, Utah|
|Huntsman Cancer Institute, University of Utah|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Katy Tsai, MD||University of California, San Francisco|