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

NCT02117024 | Terminated Phase 2 Results DMC

• 1 other identifier: HS110-201
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 16

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.

Conditions

Non Small Cell Lung Cancer

Keywords

lung; cancer; gp96; vaccine; immunotherapy; Heat Biologics; cyclophosphamide; vinorelbine; erlotinib; gemcitabine; paclitaxel; docetaxel; pemetrexed

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 3 years

Secondary Outcomes (9)

• Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)

  Up to 3 years

• Disease Control Rate (DCR)

  Up to 3 years

• 6-Month Disease Control Rate (6mDCR)

  6 months

• Overall Response Rate (ORR)

  Up to 3 years

• Progression-Free Survival (PFS)

  Up to 3 years

Study Arms (2)

Viagenpumatucel-L Plus Metronomic Cyclophosphamide

EXPERIMENTAL

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; Drug: Metronomic Cyclophosphamide

Chemotherapy Alone

ACTIVE COMPARATOR

Patients will be treated with a physician's choice regimen until progression.

Drug: Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)

Interventions

Viagenpumatucel-L DRUG

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

Also known as: HS-110

Viagenpumatucel-L Plus Metronomic Cyclophosphamide

Metronomic Cyclophosphamide DRUG

One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks

Viagenpumatucel-L Plus Metronomic Cyclophosphamide

Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed) DRUG

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

Chemotherapy Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heat Biologics: lead

Study Sites (16)

Highlands Oncology Group

Rogers, Arkansas, 72758, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

University of California at Los Angeles

Los Angeles, California, 90029, United States

Location

University of California Davis

Sacramento, California, 95817, United States

Location

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

SUNY Syracuse

Syracuse, New York, 13210, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Providence Portland Medical Center- Providence Lung Cancer Clinic

Portland, Oregon, 97213, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Oncology PA Texas Cancer Center

Abilene, Texas, 79606, United States

Location

Mary Crowley Cancer Center

Dallas, Texas, 75201, United States

Location

Cancer Care Northwest

Spokane, Washington, 99216, United States

Location

Aurora Research Institute

Green Bay, Wisconsin, 54311, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

Vinorelbine; Erlotinib Hydrochloride; Gemcitabine; Paclitaxel; Docetaxel; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Quinazolines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Limitations and Caveats

Study was discontinued prematurely (50% enrollment) by the Sponsor on 01 September 2015 due to changing treatment landscape (PD-1 approvals), and a subsequent change in development focus to IO combinations. See NCT02439450.

Results Point of Contact

• Title: Lori McDermott
• Organization: Clinical Development

lmcdermott@heatbio.com

919-794-8950

Study Officials

• Roger Cohen, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 17, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Locations

US (16)