Lung Cancer Trials Ask AI to find trials
CompletedPhase 1 / Phase 2NCT02439450
Official study title

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

Study 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 or squamous cell carcinoma for incurable or metastatic disease.

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedViagenpumatucel-L and Nivolumab

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 21, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?16 U.S. locations

Locations may change over time.

Who runs it?Heat Biologics

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Heat Biologics
Interventions being studied
Biological: Viagenpumatucel-L; Drug: Nivolumab; Drug: Pembrolizumab; Drug: Pemetrexed
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Treatment approach
Immunotherapy→Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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, but no more than three prior lines of therapy, for incurable (i.e. unresectable) or metastatic NSCLC. Up to one prior line of FDA-approved 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 the most recent 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.
Reasons someone may not be able to joinExclusion 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).

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Arizona Cancer CenterTucson, Arizona
  • UC San DiegoLa Jolla, California
  • BRRH Lynn Cancer InstituteBoca Raton, Florida
  • Memorial Cancer InstitutePembroke Pines, Florida
  • Horizon Oncology ResearchLafayette, Indiana
  • Ashland-Bellefonte Cancer CenterAshland, Kentucky
  • Baptist Health LouisvilleLouisville, Kentucky
  • Washington University School of MedicineSt Louis, Missouri
  • New York Oncology HematologyAlbany, New York
  • Winthrop HospitalMineola, New York
  • Oncology Hematology Care, Inc.Cincinnati, Ohio
  • Cleveland ClinicCleveland, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 21, 2023. Always confirm current availability with the study team.

View original record ↗