CompletedPhase 1 / Phase 2NCT02439450

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

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.

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

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations16
SponsorHeat Biologics
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.

03
Public criteria

Who may be able to participate

INCLUSION 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. EXCLUSION 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.

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