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Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC

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

NCT03326752•Dynavax Technologies Corporation

View on ClinicalTrials.gov

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).

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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 (6)

Moores UC San Diego Cancer Center

La Jolla, California, United States

Ronald Reagan University of California Los Angeles Medical Center

Santa Monica, California, United States

Allina Health, Virginia Piper Cancer Institute

Minneapolis, Minnesota, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Key Dates

Start Date

September 20, 2017

Primary Completion Date

September 19, 2019

Completion Date

September 19, 2019

Last Updated

June 17, 2020

Enrollment

ACTUAL participants

Conditions

Advanced Non Small Cell Lung Cancer

Interventions

DV281

DRUG

Breath Actuated Nebulizer

DEVICE

DV281 (RP2D)

DRUG

Approved Anti-PD-1 Inhibitor

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC

Inclusion Criteria

Exclusion Criteria

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