Vigil™ + Nivolumab in Advanced Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT02639234|
Recruitment Status : Withdrawn
First Posted : December 24, 2015
Last Update Posted : July 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Advanced Non-small Cell Lung Cancer Metastatic Non-small Cell Lung Cancer Lung Neoplasms||Biological: Vigil™ Drug: Nivolumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
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.
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.|