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

Information source: Heat Biologics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-small Cell Lung Cancer

Intervention: Viagenpumatucel-L (Biological); Theophylline (Drug); High-flow Oxygen (Other)

Phase: Phase 1

Status: Recruiting

Sponsored by: Heat Biologics

Official(s) and/or principal investigator(s):
Daniel Morgensztern, Principal Investigator, Affiliation: Washington University School of Medicine in St. Louis

Overall contact:
Victoria Brown, Phone: 919-794-7910, Email: vbrown@heatbio.com

Summary

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 who have failed at least one prior line of therapy for incurable or metastatic disease. Immunosuppression may develop in NSCLC patients in a variety of ways, and a general characteristic of NSCLC is a hypoxic tumor microenvironment. Tumor hypoxia leads to production of adenosine, via increased expression of CD39 and CD73. Adenosine is a highly immunosuppressive molecule for T cells by binding to the A2A receptor. Another source of tumor immunosuppression is expression of PD-L1 within the tumor microenvironment, which may also be regulated by tumor hypoxia. Patients will be enrolled onto a treatment arm based on eligibility and availability of open slots.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety and Tolerability by physical and laboratory examinations

Secondary outcome:

Immune Response by intracellular cytokine staining (ICS) by flow cytometry or enzyme-linked immunosorbent spot (ELISPOT)

Overall Response Rate (ORR)

Overall Survival (OS)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Non-small cell lung adenocarcinoma

- Received at least one prior line of therapy for incurable or metastatic NSCLC

- Disease progression at study entry

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1; PS=2 patients

may be considered

- 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 Exclusion Criteria:

- Received systemic anticancer therapy within the previous 21 days

- 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 treatment with a cancer vaccine for this indication

- Prior participation in a clinical study of viagenpumatucel-L

- Active respiratory or cardiac disease, which, in the opinion of the investigator,

would render the patient unsuitable for continual oxygen therapy or treatment with theophylline

- For Arms 1 and 3, patients who are already receiving supplemental oxygen

- For Arms 1 and 3, compromised lung function

- For Arms 2 and 3, cardiac arrhythmias (excluding bradyarrhythmias)

- For Arms 2 and 3, active peptic ulcer disease

- For Arms 2 and 3, uncontrolled seizures. Patients with seizures controlled on

anticonvulsants are eligible.

Locations and Contacts

Victoria Brown, Phone: 919-794-7910, Email: vbrown@heatbio.com

Horizon Oncology Research, Inc., Lafayette, Indiana 47905, United States; Recruiting
Elizabeth Morris, RN, Phone: 765-446-5165, Email: emorris@horizonbioadvance.com
Wael A Harb, MD, Principal Investigator

Washington University School of Medicine, St. Louis, Missouri 63110, United States; Recruiting
Molly Karl, Phone: 314-747-7417, Email: mkarl@dom.wustl.edu
Daniel Morgensztern, MD, Principal Investigator

Additional Information

Starting date: April 2015
Last updated: May 6, 2015

Page last updated: August 23, 2015

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