Vigil™ + Nivolumab in Advanced Non-Small Cell Lung Cancer

Part of paid clinical trials in Abilene, Texas.

Sponsor
Gradalis, Inc.
Study ID
NCT02639234
Phase
PHASE2
Status
Withdrawn

Conditions

  • Advanced Non-small Cell Lung Cancer
  • Lung Neoplasms
  • Metastatic Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vigil™ — BIOLOGICAL
    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.
  • Nivolumab — DRUG
    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.

Study Details

This is an open label phase 2 study to evaluate the combination of Vigil™ and nivolumab in advanced or metastatic NSCLC that is progressive on or after one prior platinum-based systemic therapy. Patients meeting study eligibility criteria will receive Vigil™ every 2 weeks (for a minimum of 4 and a maximum of 12 doses) and nivolumab every 2 weeks. The combination of Vigil™ and nivolumab will demonstrate a higher objective response rate (ORR) than the historical ORR of single agent nivolumab in patients with advanced NSCLC.

Key Dates

Start date
Mar 31, 2016
Status verified
Jul 2017
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Texas Oncology, P.A., Texas Cancer CenterAbileneTexas79606-
Mary Crowley Cancer Research CentersDallasTexas75230-
Cancer Care NorthwestSpokane ValleyWashington99216-

Find similar trials in Abilene, TX

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Texas Oncology, P.A., Texas Cancer Center· Abilene, TXMary Crowley Cancer Research Centers· Dallas, TXCancer Care Northwest· Spokane Valley, WA

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