CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02493361
NCT02493361Phase 2Completed

An Open-label, Phase II, Multicenter Study of Enhancing Pembrolizumab Responses in Melanoma Through Intratumoral pIL-12 Electroporation

University of California, San Francisco·interventional·Posted Jul 9, 2015·Updated Jan 6, 2021

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab and pIL-12 for Melanoma. Completed, enrolled 24 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesUnited States

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 9, 2015
Enrollment StartAug 17, 2015
Primary CompletionApr 26, 2018
Study CompletionMar 2, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.0 years ago

Interventions

Pembrolizumabdrug

pIL-12drug