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ENSIGN: ADV/HSV-tk, SBRT, and Nivolumab in NSCLC and Uveal Melanoma
NCT02831933Phase 2
Key facts
- Status
- Terminated
- Start
- Feb 2017
- Primary completion
- Nov 2020
- Countries
- 1
- Modality
- Gene Editing, Gene Silencing, Oncolytic Viruses
- Conditions
- non-small cell lung carcinoma (NSCLC)Uveal melanoma (UM)
01
Overview
Phase 2, open-label, single-arm trial of aglatimagene besadenovec in non-small cell lung carcinoma (NSCLC) and Uveal melanoma (UM). Primary endpoint: Objective Response Rate up to 6 months. Started Feb 2017; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Experimental
ADV/HSV-tk + Valacyclovir + SBRT followed by Nivolumab
03
Who it enrols
Patients with metastatic NSCLC who progressed on platinum chemo and immunotherapy, or immunotherapy-naive metastatic uveal melanoma. EGFR/ALK+ NSCLC allowed only if progressed on targeted therapy.
04
Endpoints
Primary
Objective Response Rate
Secondary
Overall Survival Rate
Progression Free Survival Rate
Clinical Benefit Rate
Duration of Response
Safety and Toxicity
Immune-mediated Antitumor Activity
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