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A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02117024
First Posted: April 17, 2014
Last Update Posted: April 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Heat Biologics
  Purpose
This study will test whether vaccination with viagenpumatucel-L combined with low-dose cyclophosphamide will prolong the survival of patients with non-small cell lung cancer (NSCLC) who have failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone. Patients will be randomized 2 to 1 into the viagenpumatucel-L arm and the chemotherapy alone arm, respectively.

Condition Intervention Phase
Non Small Cell Lung Cancer Drug: Viagenpumatucel-L Drug: Metronomic Cyclophosphamide Drug: Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Viagenpumatucel-L (HS-110) in Combination With Low Dose (Metronomic) Cyclophosphamide Versus Chemotherapy Alone in Patients With Non-Small Cell Lung Adenocarcinoma After Failure of Two or Three Previous Treatment Regimens for Advanced Disease

Resource links provided by NLM:


Further study details as provided by Heat Biologics:

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: Up to 3 years ]

Secondary Outcome Measures:
  • Safety [ Time Frame: Up to 3 years ]
    Evaluate the safety of the combination of viagenpumatucel-L and low-dose cyclophosphamide

  • Disease Control Rate (DCR) [ Time Frame: Up to 3 years ]
    Evaluate immune-related DCR (irDCR) and also DCR by Response Evaluation Criteria in Solid Tumors (RECIST) (complete response, partial response, and stable disease)

  • 6-Month Disease Control Rate (6mDCR) [ Time Frame: 6 months ]
    Evaluate 6-month immune-related DCR (6m-irDCR) and also 6mDCR by RECIST (complete response, partial response, and stable disease at 6 months following randomization)

  • Overall Response Rate (ORR) [ Time Frame: Up to 3 years ]
    Evaluate immune-related ORR (irORR) and also ORR by RECIST (complete response and partial response)

  • Progression-Free Survival (PFS) [ Time Frame: Up to 3 years ]
    Evaluate immune-related PFS (irPFS) and also PFS by RECIST

  • Time to Progression (TTP) [ Time Frame: Up to 3 years ]
    Evaluate immune-related TTP (irTTP) and also TTP by RECIST

  • Survival at 6 months [ Time Frame: 6 months ]
    Evaluate the proportion of patients who are alive at 6 months following randomization

  • Survival at 12 months [ Time Frame: 12 months ]
    Evaluate the proportion of patients who are alive at 12 months following randomization

  • Immune Response [ Time Frame: Up to 3 years ]
    Characterize the peripheral blood immunologic response via intracellular cytokine staining (ICS) by flow cytometry and/or enzyme-linked immunosorbent spot (ELISPOT) on cluster of differentiation 8 positive (CD8+) cells following vaccination


Other Outcome Measures:
  • Tumor expression analysis [ Time Frame: At screening ]
  • Tumor infiltrating lymphocytes (TILs) [ Time Frame: 12 weeks after first dose of vaccine ]

Estimated Enrollment: 123
Study Start Date: July 2014
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Viagenpumatucel-L Plus Metronomic Cyclophosphamide
Viagenpumatucel-L (HS-110) given as 1*10^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.
Drug: Viagenpumatucel-L
Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
Other Name: HS-110
Drug: Metronomic Cyclophosphamide
One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
Active Comparator: Chemotherapy Alone
Patients will be treated with a physician's choice regimen until progression.
Drug: Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)

Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:

  • Vinorelbine
  • Erlotinib
  • Gemcitabine
  • Paclitaxel
  • Docetaxel
  • Pemetrexed

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-small cell lung adenocarcinoma
  • At least 2 and no more than 3 prior lines of therapy for incurable or metastatic NSCLC
  • Suitable for conventional single agent chemotherapy
  • 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 or radiation therapy within the previous 14 days
  • Received more than 3 lines of prior conventional therapy for advanced disease
  • Human immunodeficiency virus (HIV), hepatitis B or C, or severe/uncontrolled infections or intercurrent illness, unrelated to the tumor, requiring active therapy
  • Any condition requiring concurrent systemic immunosuppressive therapy
  • Known immunodeficiency disorders
  • Known leptomeningeal disease
  • Other active malignancies
  • Prior treatment with a cancer vaccine for this indication
  • Pregnant or breastfeeding
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117024


Locations
United States, Arkansas
Highlands Oncology Group
Rogers, Arkansas, United States, 72758
United States, California
University of California San Diego
La Jolla, California, United States, 92093
University of California at Los Angeles
Los Angeles, California, United States, 90029
University of California Davis
Sacramento, California, United States, 95817
United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
SUNY Syracuse
Syracuse, New York, United States, 13210
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Oregon
Providence Portland Medical Center- Providence Lung Cancer Clinic
Portland, Oregon, United States, 97213
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Texas Oncology PA Texas Cancer Center
Abilene, Texas, United States, 79606
Mary Crowley Cancer Center
Dallas, Texas, United States, 75201
United States, Washington
Cancer Care Northwest
Spokane, Washington, United States, 99216
United States, Wisconsin
Aurora Research Institute
Green Bay, Wisconsin, United States, 54311
Sponsors and Collaborators
Heat Biologics
Investigators
Principal Investigator: Roger Cohen, MD University of Pennsylvania
  More Information

Responsible Party: Heat Biologics
ClinicalTrials.gov Identifier: NCT02117024     History of Changes
Other Study ID Numbers: HS110-201
First Submitted: April 15, 2014
First Posted: April 17, 2014
Last Update Posted: April 24, 2017
Last Verified: April 2017

Keywords provided by Heat Biologics:
Heat Biologics
lung
cancer
gp96
vaccine
immunotherapy
cyclophosphamide
vinorelbine
erlotinib
gemcitabine
paclitaxel
docetaxel
pemetrexed

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Vinorelbine
Docetaxel
Gemcitabine
Albumin-Bound Paclitaxel
Cyclophosphamide
Erlotinib Hydrochloride
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents