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

NCT03326752 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-06-17

No results posted yet for this study

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).

Conditions

  • Advanced Non Small Cell Lung Cancer

Interventions

DRUG

DV281

\- Dose Escalation will be the preliminary dose finding phase of the study. Subjects will be enrolled to available Dosing Cohorts.

DEVICE

Breath Actuated Nebulizer

Breath-actuated, electronic system designed to aerosolize liquid medication.

DRUG

DV281 (RP2D)

\- Dose Expansion will be enrolled into 4 groups based on NSCLC characteristics.

DRUG

Approved Anti-PD-1 Inhibitor

FDA approved Anti-PD-1 Inhibitor

Sponsors & Collaborators

  • Dynavax Technologies Corporation

    lead INDUSTRY

Principal Investigators

  • Edward Garon, MD · University of California, Los Angeles

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-20
Primary Completion
2019-09-19
Completion
2019-09-19
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03326752 on ClinicalTrials.gov