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NCT02493361 · ClinicalTrials.gov registry record · Phase 2
Trial of pIL-12/MK-3475 in Metastatic Melanoma
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT02493361: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT02493361 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02493361, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a multicenter, Phase II, open-label, 42-patient single-arm trial of intratumoral pIL-12 electroporation (EP) in combination with pembrolizumab in patients with melanoma. Patients will be evaluated in 2 parts. Part A patients will be selected using a flow cytometric assay that quantifies intratumoral PD-1hiCD8+CTLA4+ "exhausted" lymphocytes in the tumor. Part B will enroll patients who have or are failing pembrolizumab at least 12 weeks after starting Programmed cell death protein 1 (PD-1) antibody alone or in combination, or, who have been selected using a flow cytometric assay that quantifies intratumoral PD-1hiCD8+CTLA4+ "exhausted" lymphocytes in the tumor.
Primary Outcome
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
Interventions
- DRUG Pembrolizumab
- DRUG pIL-12
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-08-17 |
| Est. Completion | 2020-03-02 |
| Phase | Phase 2 |
What the finished NCT02493361 record still lists
NCT02493361 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT02493361 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02493361 about?
NCT02493361 is a clinical study titled "Trial of pIL-12/MK-3475 in Metastatic Melanoma". This is a multicenter, Phase II, open-label, 42-patient single-arm trial of intratumoral pIL-12 electroporation (EP) in combination with pembrolizumab in patients with melanoma. Patients will be evaluated in 2 parts. Part A patients will be selected using a flow cytometric assay that quantifies intr...
What is the current status of trial NCT02493361?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2015-08-17. Estimated completion is 2020-03-02.
What interventions are being tested in trial NCT02493361?
The interventions under investigation include: Pembrolizumab (DRUG), pIL-12 (DRUG).
Who is sponsoring clinical trial NCT02493361?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02493361's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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