A Study of Combination Therapies With Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

121

Participants

Timeline

Start Date

April 15, 2015

Primary Completion Date

May 3, 2021

Study Completion Date

November 4, 2022

Conditions
Non-small Cell Lung Cancer
Interventions
BIOLOGICAL

Viagenpumatucel-L

Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig

DRUG

Nivolumab

Nivolumab 240mg IV q2weeks for 18 weeks or until disease progression or unacceptable toxicity. After the completion of 18 weeks of combination therapy, patients may receive either nivolumab dosing schedule listed in the current approved package insert (every 2 weeks or every 4 weeks) per Investigator discretion.

DRUG

Pembrolizumab

The recommended dose of KEYTRUDA (pembrolizumab) is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

DRUG

Pemetrexed

The recommended dose of ALIMTA (pemetrexed) when administered with carboplatin and pembrolizumab for the initial treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m2 administered as an intravenous infusion over 10 minutes prior to carboplatin on Day 1 of each 21-day cycle for 4 cycles. Pembrolizumab should be administered prior to ALIMTA when given on the same day.

Trial Locations (16)

11501

Winthrop Hospital, Mineola

12206

New York Oncology Hematology, Albany

19104

University of Pennsylvania, Philadelphia

22031

Virginia Cancer Specialists, Fairfax

33028

Memorial Cancer Institute, Pembroke Pines

33486

BRRH Lynn Cancer Institute, Boca Raton

40207

Baptist Health Louisville, Louisville

41101

Ashland-Bellefonte Cancer Center, Ashland

44195

Cleveland Clinic, Cleveland

45242

Oncology Hematology Care, Inc., Cincinnati

47905

Horizon Oncology Research, Lafayette

63110

Washington University School of Medicine, St Louis

85724

University of Arizona Cancer Center, Tucson

92093

UC San Diego, La Jolla

97213

Providence Portland Medical Center, Portland

02903

Rhode Island Hospital, Providence

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Heat Biologics

INDUSTRY