Summary

for people ages 18 years and up (full criteria)
at UCSD
study started
estimated completion:
Lyudmila Bazhenova (ucsd)

Description

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. These methods collectively use the body's immune system to target the patient's own tumor. Immunosuppression hinders that response, and may develop in NSCLC patients in a variety of ways, such as activation of checkpoint pathways in the tumor microenvironment. Drugs that disrupt checkpoint molecule signaling like anti-PD-1 monoclonal antibodies nivolumab, may release this brake on the immune system. Tumor expression of PD-L1 plays an important role in patient response to checkpoint inhibitors; in general, clinical response to checkpoint inhibitors requires tumor expression of PD-L1 and presence of Tumor Infiltrating Lymphocytes (TIL). Combining viagenpumatucel-L with anti-PD-1 agents may enhance the vaccine's anti-tumor activity while prolonging or increasing the efficacy of the checkpoint inhibitor.

Official Title

A Phase 1b/2 Study of Viagenpumatucel-L (HS-110) in Combination With Multiple Treatment Regimens in Patients With Non-Small Cell Lung Cancer (The "DURGA" Trial)

Keywords

Non-small Cell Lung Cancer lung cancer gp96 vaccine immunotherapy Heat Biologics Nivolumab checkpoint inhibitor Lung Neoplasms Carcinoma, Non-Small-Cell Lung Pembrolizumab Pemetrexed Antibodies, Monoclonal Viagenpumatucel-L

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 for incurable or metastatic NSCLC.Up to one prior line of 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 first 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.

You CAN'T join if...

  • 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).

Locations

  • UC San Diego accepting new patients
    La Jolla California 92093 United States
  • Ridley Tree Cancer Center - Sansum Clinic not yet accepting patients
    Santa Barbara California 93105 United States

Lead Scientist

  • Lyudmila Bazhenova (ucsd)
    Dr. Bazhenova’s clinical practice and research concentrate on lung cancer, particularly as this relates to females and non-smokers. She actively participates in cooperative group trials, and takes an active role in designing and implementing clinical investigations, including phase II studies and correlative science projects with several UCSD investigators.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Heat Biologics
ID
NCT02439450
Phase
Phase 1/2
Study Type
Interventional
Last Updated