Back to resultsA Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer
Primary Purpose
Non Small Cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Viagenpumatucel-L
Metronomic Cyclophosphamide
Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring lung, cancer, gp96, vaccine, immunotherapy, Heat Biologics, cyclophosphamide, vinorelbine, erlotinib, gemcitabine, paclitaxel, docetaxel, pemetrexed
Eligibility 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
Sites / Locations
- Highlands Oncology Group
- University of California San Diego
- University of California at Los Angeles
- University of California Davis
- Georgia Regents University
- University of Maryland Greenebaum Cancer Center
- University of Massachusetts
- Washington University School of Medicine
- SUNY Syracuse
- Gabrail Cancer Center
- Providence Portland Medical Center- Providence Lung Cancer Clinic
- University of Pennsylvania
- Texas Oncology PA Texas Cancer Center
- Mary Crowley Cancer Center
- Cancer Care Northwest
- Aurora Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Viagenpumatucel-L Plus Metronomic Cyclophosphamide
Chemotherapy Alone
Arm Description
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.
Patients will be treated with a physician's choice regimen until progression.
Outcomes
Primary Outcome Measures
Overall Survival (OS)
Overall survival (OS) calculated as the duration of survival from the date of randomization to the date of death from any cause, or was censored on the date the patient was last known to be alive.
Survival time was calculated from the randomization date up to the date of death,or censored on the date that the patient was last known to be alive (last available visit date) utilizing Kaplan-Meier Estimate of Overall Survival Ending Events
Secondary Outcome Measures
Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Evaluate the safety of the combination of viagenpumatucel-L and low-dose cyclophosphamide by frequency of Treatment-Emergent Adverse Events
Disease Control Rate (DCR)
Evaluate overall 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)
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)
Evaluate immune-related ORR (irORR) and also ORR by RECIST (complete response and partial response)
Progression-Free Survival (PFS)
Evaluate immune-related PFS (irPFS) and PFS by RECIST (Response Evaluation Criteria for Solid Tumors)
Time to Progression (TTP)
Evaluate immune-related TTP (irTTP) and also TTP (Time to Progression) by RECIST
Survival at 6 Months
Evaluate the proportion of patients who are alive at 6 months following randomization
Survival at 12 Months
Evaluate the proportion of patients who are alive at 12 months following randomization
Immune Response
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02117024
Brief Title
A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Sponsor Decision; strategic - based on changing treatment landscape
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heat Biologics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Determine whether viagenpumatucel-L combined with low-dose cyclophosphamide prolongs survival in patients with NSCLC who failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
lung, cancer, gp96, vaccine, immunotherapy, Heat Biologics, cyclophosphamide, vinorelbine, erlotinib, gemcitabine, paclitaxel, docetaxel, pemetrexed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Viagenpumatucel-L Plus Metronomic Cyclophosphamide
Arm Type
Experimental
Arm Description
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.
Arm Title
Chemotherapy Alone
Arm Type
Active Comparator
Arm Description
Patients will be treated with a physician's choice regimen until progression.
Intervention Type
Drug
Intervention Name(s)
Viagenpumatucel-L
Other Intervention Name(s)
HS-110
Intervention Description
Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
Intervention Type
Drug
Intervention Name(s)
Metronomic Cyclophosphamide
Intervention Description
One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
Intervention Type
Drug
Intervention Name(s)
Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival (OS) calculated as the duration of survival from the date of randomization to the date of death from any cause, or was censored on the date the patient was last known to be alive.
Survival time was calculated from the randomization date up to the date of death,or censored on the date that the patient was last known to be alive (last available visit date) utilizing Kaplan-Meier Estimate of Overall Survival Ending Events
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Description
Evaluate the safety of the combination of viagenpumatucel-L and low-dose cyclophosphamide by frequency of Treatment-Emergent Adverse Events
Time Frame
Up to 3 years
Title
Disease Control Rate (DCR)
Description
Evaluate overall immune-related DCR (irDCR) and also DCR by Response Evaluation Criteria in Solid Tumors (RECIST) (complete response, partial response, and stable disease)
Time Frame
Up to 3 years
Title
6-Month Disease Control Rate (6mDCR)
Description
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)
Time Frame
6 months
Title
Overall Response Rate (ORR)
Description
Evaluate immune-related ORR (irORR) and also ORR by RECIST (complete response and partial response)
Time Frame
Up to 3 years
Title
Progression-Free Survival (PFS)
Description
Evaluate immune-related PFS (irPFS) and PFS by RECIST (Response Evaluation Criteria for Solid Tumors)
Time Frame
Up to 3 years
Title
Time to Progression (TTP)
Description
Evaluate immune-related TTP (irTTP) and also TTP (Time to Progression) by RECIST
Time Frame
Up to 3 years
Title
Survival at 6 Months
Description
Evaluate the proportion of patients who are alive at 6 months following randomization
Time Frame
6 months
Title
Survival at 12 Months
Description
Evaluate the proportion of patients who are alive at 12 months following randomization
Time Frame
12 months
Title
Immune Response
Description
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
Time Frame
Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Cohen, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Highlands Oncology Group
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California at Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90029
Country
United States
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
SUNY Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Providence Portland Medical Center- Providence Lung Cancer Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Texas Oncology PA Texas Cancer Center
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Mary Crowley Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75201
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
Aurora Research Institute
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer
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