Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion:
Edward Garon (ucla)

Description

Summary

This open-label, multicenter, dose-escalation and expansion trial is designed to evaluate the safety and preliminary efficacy of inhaled DV281 in combination with nivolumabfor the treatment of NSCLC and to select a recommended phase 2 dose (RP2D).

Official Title

Phase 1b Dose Escalation and Dose Expansion Trial of DV281 in Combination With an Approved Anti-PD-1 Inhibitor in Subjects With Advanced Non-Small Cell Lung Cancer

Details

Pre-clinical studies support the proposed dosing schema to be tested and a potential benefit of the combination of inhaled DV281 with nivolumab for subjects with advanced NSCLC. This study (DV9-NSC-01) is designed for establishing an immunologically optimal RP2D for inhaled DV281 in combination with an approved anti-PD-1 inhibitor. This trial, studying the potential to enhance the efficacy of an approved anti-PD-1 inhibitor in subjects with advanced NSCLC, addresses an unmet need for NSCLC patients having tumors that do not respond or do not respond adequately to anti-PD-1 inhibitor monotherapy.

Keywords

Advanced Non Small Cell Lung Cancer Cancer Lung Cancer NSCLC Anti-PD-1 inhibitor Immuno-oncology Toll-Like Receptor (TLR) agonist Lung Neoplasms Carcinoma, Non-Small-Cell Lung Nivolumab DV281 Breath Actuated Nebulizer DV281 (RP2D) Approved Anti-PD-1 Inhibitor Dose Expansion (RP2D)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Have documented histologically or cytologically confirmed advanced NSCLC as the dominant histology.
  • If confirmed EGFR or ALK directed testing warrants actionable targeted therapy, must have confirmed disease progression on targeted therapy or cannot tolerate targeted therapy.
  • Aged 18 years and older on the day of signing informed consent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2 for Dose Escalation phase and ECOG PS 0 to 1 for Dose Expansion phase
  • Adequate organ function as indicated by laboratory values
  • Life expectancy, in the opinion of the investigator, of at least 3 months

You CAN'T join if...

  • Condition of the subjects lung anatomy is such that proper delivery of inhaled DV281 to the specific location of intra-thoracic tumor(s) could be compromised
  • Any known additional malignancy that is progressing or required active treatment in the last 3 years
  • Current or history of clinically significant non-infectious pneumonitis
  • History of clinically severe lung disease, asthma, or chronic obstructive pulmonary disease (COPD) requiring emergency management and/or hospitalization in the last year
  • Received more than 30 Gy of conventional radiation therapy in the thoracic region within 26 weeks prior to study enrollment
  • Is expected to require any other form of anti-cancer therapy while in the trial.Zoledronic acid or denosumab as supportive care for bone metastases will be allowed if started prior to study enrollment
  • Diagnosis of immunodeficiency or is receiving systemic steroid therapy (>10 mg of prednisone or equivalent) or any other form of immunosuppressive therapy (including immune modulators or systemic corticosteroids) that cannot be discontinued safely within 14 days prior to study enrollment
  • Has a medical condition that requires immunosuppression
  • Active autoimmune disease requiring systemic treatment in the past 2 years or a disease that requires immunosuppressive medication including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency)is not considered a form of systemic treatment.
  • Known central nervous system metastases, brain metastases, or carcinomatous meningitis

Locations

  • Ronald Reagan University of California Los Angeles Medical Center accepting new patients
    Santa Monica California 90404 United States
  • Seattle Cancer Care Alliance accepting new patients
    Seattle Washington 98109 United States

Lead Scientist

  • Edward Garon (ucla)
    Health Sciences Associate Clinical Professor, Medicine. Authored (or co-authored) 109 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Dynavax Technologies Corporation
ID
NCT03326752
Phase
Phase 1
Study Type
Interventional
Last Updated