Vigil™ + Nivolumab in Advanced Non-Small Cell Lung Cancer
|Advanced Non-small Cell Lung Cancer Metastatic Non-small Cell Lung Cancer Lung Neoplasms||Biological: Vigil™ Drug: Nivolumab||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of Vigil™ Augmented Autologous Tumor Cell Immunotherapy in Combination With Nivolumab PD-1 Inhibitor for Patients With Advanced Non-Small Cell Lung Cancer|
- Objective Response Rate (ORR) by RECIST 1.1 criteria of Vigil™ plus nivolumab in patients with NSCLC after failure of prior platinum-based chemotherapy [ Time Frame: 12 months ]The primary endpoint of ORR is defined as a best response of complete remission (CR) or partial remission (PR) according to RECIST 1.1 as determined by the investigator.
- Tolerability and safety profile of Vigil™ combined with nivolumab (all adverse events (CTCAE 4.03), laboratory safety assessments, and physical examination findings) [ Time Frame: 12 months ]Safety endpoints include all adverse events (CTCAE 4.03), laboratory safety assessments, and physical examination findings.
- Progression-Free Survival (PFS) of study patients treated with Vigil™ and nivolumab [ Time Frame: 12 months ]The secondary efficacy endpoint of PFS is the time from randomization to progression according to RECIST version 1.1 or until death from any cause, whichever comes first.
|Study Start Date:||March 2016|
|Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Experimental: Vigil™ + Nivolumab
Patients meeting study eligibility criteria will receive doublet therapy comprising of (i) Vigil™ 1 x 10^7 cells by intradermal injection every 2 weeks (for a minimum of 4 and a maximum of 12 doses) and (ii) nivolumab 3 mg/kg by intravenous infusion over 60 minutes every 2 weeks.
Upon completion of nivolumab infusion, subjects will receive Vigil™, 1.0 x 10^7cells via intradermal injection on Day 1 every 14 days for a minimum of 4 and a maximum of 12 doses depending on quantity of Vigil™ manufactured from surgical specimens.
Other Names:Drug: Nivolumab
Prior to Vigil™, subjects will receive nivolumab 3 mg/kg by intravenous infusion over 60 minutes on Day 1 every 14 days. If nivolumab is administered beyond 12 months it will be administered off study.
This is an open label phase 2 study to evaluate the combination of Vigil™ autologous tumor cell immunotherapy and nivolumab PD-1 inhibitor therapy in patients with advanced or metastatic NSCLC that is progressive on or after one prior platinum-based systemic therapy (ALK or EGFR mutation-targeted therapy should have been received if appropriate mutation present).
Patients undergoing a standard surgical procedure (e.g., tumor biopsy, palliative resection, or thoracentesis of malignant pleural effusion) may elect to have tumor tissue procured for manufacture of Vigil™ vaccine. Patients meeting study eligibility criteria will receive doublet therapy comprising of (i) Vigil™ 1 x 10^7 cells by intradermal injection every 2 weeks for a minimum of 4 and a maximum of 12 doses and (ii) nivolumab 3 mg/kg by intravenous infusion over 60 minutes every 2 weeks. Three to six weeks after tissue procurement has occurred eligibility will be reconfirmed by the study site. Subjects must begin the study regimen within 6 weeks of tissue procurement. Radiological assessment of tumor response will be performed at screening, Cycle 5 (Week 9) and approximately every 2 months thereafter until progressive disease unless the subject is lost to follow-up, withdraws consent for study related procedures, or initiates another cancer therapy. Tumor biopsy for correlative studies should be obtained at tissue procurement and at Cycle 5 (Week 9). Peripheral blood mononuclear cells (PBMC) for correlative studies should be obtained before tumor procurement, and prior to initiation of study therapy on Day 1 at Cycle 1 (Week 1), Cycle 5 (Week 9), Cycle 9 (Week 17) and EOT.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02639234
|United States, Texas|
|Texas Oncology, P.A., Texas Cancer Center|
|Abilene, Texas, United States, 79606|
|Mary Crowley Cancer Research Centers|
|Dallas, Texas, United States, 75230|
|United States, Washington|
|Cancer Care Northwest|
|Spokane Valley, Washington, United States, 99216|
|Study Director:||Luisa Manning, MD||Gradalis, Inc.|