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 : January 6, 2021
|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 Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI. The ORR is the proportion of participants with either a Complete Response (CR) defined as a 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 or a Partial Response (PR) defined as a >=30% decrease in the sum of the longest diameter of target lesions with no appearance of new lesions. ORR = CR + PR.
- Best Overall ORR Determined by Immune Related-Response Criteria (irRC) [ Time Frame: Up to 5 years ]Best overall objective response rate is defined as the proportion of participants with a demonstrated complete or partial response according to irRC. In the irRC, an immune-related Complete Response (irCR) is the disappearance of all lesions, measured or unmeasured, and no new lesions; an immune-related Partial Response (irPR) is a 50% drop in tumour burden from baseline as defined by the irRC.
- Twenty-Four Week Landmark Progression Free Survival (PFS) [ 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 (+ / - 2 days visit tolerance). Tumor response determinations were assessed by RECIST v1.1.
- Number of Participants With Treatment-related Adverse Events [ Time Frame: Up to 2 years ]The study will use the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0 with an adverse or serious adverse event determination of possible, probable, or definite attribution. Analyses will be performed for all patients having received at least one dose of study drug.
- Median PFS [ Time Frame: Up to 5 years ]PFS is defined as the duration between the date of treatment initiation to the first date of either disease progression where progression is assessed by RECIST v1.1, or death.
- Duration of Response (DOR) Estimate [ Time Frame: Up to 5 years ]DOR is defined as the number of days from the initial documentation of an objective response (CR or PR) per RECIST v1.1 criteria to the final evaluation of that response (censored duration), or to documentation of progression using Kaplan-Meier (KM) estimates .
- Overall Survival (OS) Estimate [ Time Frame: Up to 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 using KM estimates.
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|