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



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/14/2018
Start Date:April 15, 2015
End Date:December 2021
Contact:Lalaine Nguyen
Email:Lnguyen@heatbio.com
Phone:760-539-7388

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A Phase 1b/2 Study of Viagenpumatucel-L (HS-110) in Combination With Multiple Treatment Regimens in Patients With Non-Small Cell Lung Cancer (The "DURGA" Trial)

This study will test whether vaccination with viagenpumatucel-L combined with strategies to
modulate the immune response is safe for patients with non-small cell lung adenocarcinoma or
squamous cell carcinoma for incurable or metastatic disease. These methods collectively use
the body's immune system to target the patient's own tumor. Immunosuppression hinders that
response, and may develop in NSCLC patients in a variety of ways, such as activation of
checkpoint pathways in the tumor microenvironment. Drugs that disrupt checkpoint molecule
signaling like anti-PD-1 monoclonal antibodies nivolumab, may release this brake on the
immune system. Tumor expression of PD-L1 plays an important role in patient response to
checkpoint inhibitors; in general, clinical response to checkpoint inhibitors requires tumor
expression of PD-L1 and presence of Tumor Infiltrating Lymphocytes (TIL). Combining
viagenpumatucel-L with anti-PD-1 agents may enhance the vaccine's anti-tumor activity while
prolonging or increasing the efficacy of the checkpoint inhibitor.


INCLUSION CRITERIA:

- Non-small cell lung adenocarcinoma or squamous cell carcimona

- At least one site of measurable disease by RECIST 1.1

- Arm 5: Received at least one prior line of therapy for incurable or metastatic NSCLC.
Up to one prior line of checkpoint inhibitor therapy is permitted (must have received
at least 4 months of treatment) --OR--

- Arm 6: Received front line immunotherapy (with or without chemotherapy) for incurable
or metastatic NSCLC and did not progress clinically or radiographically per RECIST 1.1
at first imaging assessment, and will begin maintenance immunotherapy with standard of
care pembrolizumab ± pemetrexed.

- Life expectancy ≥18 weeks

- Arm 5: Disease progression at study entry --OR--

- Arm 6: Documented Stable Disease, Partial Response, Complete Response (SD/PR/CR) per
RECIST 1.1 after a minimum of 9 to 12 weeks of front line immunotherapy (with or
without chemotherapy).

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

- Central nervous system (CNS) metastases may be permitted but must be treated and
neurologically stable

- Adequate laboratory parameters

- Willing and able to comply with the protocol and sign informed consent

- Female patients who are of childbearing potential and fertile male patients must agree
to use an effective form of contraception throughout study participation

- Willing to provide archival or fresh tumor biopsy at Screening, and fresh tumor biopsy
at Week 10 when feasible.

- Arm 5: Suitable for treatment with nivolumab per package insert --OR--

- Arm 6: Suitable for front line maintenance treatment with pembrolizumab ± pemetrexed
per the current approved package inserts.

EXCLUSION CRITERIA:

- Arm 5: Received systemic anticancer therapy within 21 days prior to first dose of
study drug

- Human immunodeficiency virus (HIV), hepatitis B or C, or severe/uncontrolled
infections or concurrent illness, unrelated to the tumor, requiring active therapy

- Any condition requiring concurrent systemic immunosuppressive therapy

- Known immunodeficiency disorders, either primary or acquired

- Known leptomeningeal disease

- Active malignancies within 12 months with the exception of those with a negligible
risk of metastasis or death treated with expected curative outcome

- Pregnant or breastfeeding

- Prior participation in a clinical study of viagenpumatucel-L (HS-110)

- Administration of a live vaccine within 30 days prior to first dose of study drug

- Active, known or suspected autoimmune disease

- Significant cardiovascular disease

- Refractory to prior immunotherapy (clinical or radiographic progression after 12 weeks
or less of immunotherapy).
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Principal Investigator: John Wallmark, MD
Phone: 240-826-2140
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Vamsi Velcheti, MD
Phone: 216-445-7101
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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4805 Northeast Glisan Street
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(503) 215-1111
Principal Investigator: Rachel Sanborn, MD
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Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Hina Khan, MD
Phone: 401-444-8559
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Abilene, Texas 79606
Principal Investigator: Anton Melnyk, MD
Phone: 325-692-0188
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Albany, New York 12206
Principal Investigator: Makenzi Evangelist, MD
Phone: 518-489-3612
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Ashland, Kentucky 41101
Principal Investigator: Venu Konala, MD
Phone: 606-836-0202
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Boca Raton, Florida 33486
Principal Investigator: Edgardo Santos, MD
Phone: 561-955-5630
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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Principal Investigator: Nashat Gabrail, MD
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5053 Wooster Rd
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Denver, Colorado 80218
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Englewood, Colorado 80113
Principal Investigator: David Trevarthen, MD
Phone: 303-788-8675
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8503 Arlington Blvd., Ste. 400
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Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Phone: 858-534-8248
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Principal Investigator: Wael Harb, MD
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Phone: 502-721-6012
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Mineola, New York 11501
Principal Investigator: Jeffrey Schneider, MD
Phone: 516-663-4895
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Pembroke Pines, Florida 33025
Principal Investigator: Luis Raez, MD
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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660 S Euclid Ave
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