Advanced Non Small Cell Lung CancerPhase 1NCT03326752
Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC
A Phase 1 study testing DV281, Breath Actuated Nebulizer and DV281 (RP2D) in people with Advanced Non Small Cell Lung Cancer, run by Dynavax Technologies Corporation at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non Small Cell Lung Cancer
- What is being tested?
- DV281, Breath Actuated Nebulizer and DV281 (RP2D)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Sep 2017to 19 Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Moores UC San Diego Cancer Center
La Jolla, California, 92093
Allina Health, Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
Sarah Cannon Research Institute
Nashville, Tennessee, 37201
Ronald Reagan University of California Los Angeles Medical Center
Santa Monica, California, 90404
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
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
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).
Read the 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.
- Conditions
- Advanced Non Small Cell Lung Cancer
- Being tested
- DV281, Breath Actuated Nebulizer, DV281 (RP2D), Approved Anti-PD-1 Inhibitor
- Keywords
- Cancer, Lung Cancer, NSCLC, Anti-PD-1 inhibitor, Immuno-oncology, Toll-Like Receptor (TLR) agonist
- Medical subject headings
- Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DV281Drug
- Dose Escalation will be the preliminary dose finding phase of the study. Subjects will be enrolled to available Dosing Cohorts.
Breath Actuated NebulizerDevice
Also called Nebulizer
Breath-actuated, electronic system designed to aerosolize liquid medication.
DV281 (RP2D)Drug
- Dose Expansion will be enrolled into 4 groups based on NSCLC characteristics.
Approved Anti-PD-1 InhibitorDrug
Also called nivolumab
FDA approved Anti-PD-1 Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort 1-5 | Experimental | Cohort 1-4
* DV281 - Dose Level 1-5
* DV281 in combination with nivolumab
* DV281 is administered via a breath actuated nebulizer Receives: Drug: DV281; Device: Breath Actuated Nebulizer; Drug: Approved Anti-PD-1 Inhibitor |
| Dose Expansion (RP2D) | Experimental | 4 Cohorts
* Preliminary Recommended Phase 2 dosing of DV281 in combination with nivolumab
* Cohort 1: Non-squamous and non-EGFR/ ALK mutation and progressed on anti-PD-1/L1 therapy
* Cohort 2: Non-squamous and EGFR/ ALK mutation and progressed on targeted therapy
* Cohort 3: Squamous and anti-PD-1/ L1 therapy experienced
* Cohort 4: Squamous and anti-PD-1/L1 therapy naive
* DV281 is administered via a breath actuated nebulizer. Receives: Device: Breath Actuated Nebulizer; Drug: DV281 (RP2D); Drug: Approved Anti-PD-1 Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation
Incidence of dose-limiting toxicities (DLTs)
Measured: DLT assessment period - Day 1 through Day 28.
Dose Expansion
Objective response rate (ORR) of dosing regimen established during the Dose Escalation
Measured: 1 year after last subject is enrolled in the Dose Expansion phase of study
Dose Expansion
Duration of Response (DOR) and time to response.
Measured: 1 year after last subject is enrolled in the Dose Expansion phase of the Study
Secondary outcomes (2)
Dose Escalation
Assess IFN-a induced gene expression in blood when DV281 is administered as a monotherapy and in combination with an approved anti-PD-1 inhibitor
Measured: IFN response assessment period - Day 1 through Day 21
Dose Expansion
Incidence of treatment related AE's as assessed by CTCAE Version 4.03
Measured: 1 year after last subject is enrolled in the Dose Expansion phase of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start20 Sep 2017
- Primary completion19 Sep 2019
- Study completion19 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- * In the Dose Escalation phase of the study, 5 DV281 dose cohorts will be evaluated in combination with an approved anti-PD-1 Inhibitor. * The Dose Expansion phase of the study will establish the Recommended Phase 2 Dose of DV281 in combination with an approved anti-PD-1 inhibitor.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynavax Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Garon, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326752
- Sponsor's protocol ID
- DV9-NSC-01
- Status last verified
- Jun 2020
- First submitted
- 19 Oct 2017
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03326752
- Acronym / sponsor ID
- DV9-NSC-01
- Conditions
- Advanced Non Small Cell Lung Cancer
- Keywords
- Cancer, Lung Cancer, NSCLC, Anti-PD-1 inhibitor, Immuno-oncology, Toll-Like Receptor (TLR) agonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * In the Dose Escalation phase of the study, 5 DV281 dose cohorts will be evaluated in combination with an approved anti-PD-1 Inhibitor. * The Dose Expansion phase of the study will establish the Recommended Phase 2 Dose of DV281 in combination with an approved anti-PD-1 inhibitor.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort 1-5 | Experimental | Drug: DV281, Device: Breath Actuated Nebulizer, Drug: Approved Anti-PD-1 InhibitorCohort 1-4 * DV281 - Dose Level 1-5 * DV281 in combination with nivolumab * DV281 is administered via a breath actuated nebulizer |
| Dose Expansion (RP2D) | Experimental | Device: Breath Actuated Nebulizer, Drug: DV281 (RP2D), Drug: Approved Anti-PD-1 Inhibitor4 Cohorts * Preliminary Recommended Phase 2 dosing of DV281 in combination with nivolumab * Cohort 1: Non-squamous and non-EGFR/ ALK mutation and progressed on anti-PD-1/L1 therapy * Cohort 2: Non-squamous and EGFR/ ALK mutation and progressed on targeted therapy * Cohort 3: Squamous and anti-PD-1/ L1 therapy experienced * Cohort 4: Squamous and anti-PD-1/L1 therapy naive * DV281 is administered via a breath actuated nebulizer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DV281- Dose Escalation will be the preliminary dose finding phase of the study. Subjects will be enrolled to available Dosing Cohorts. | Drug | Dose Escalation Cohort 1-5 |
| Breath Actuated NebulizerAlso: NebulizerBreath-actuated, electronic system designed to aerosolize liquid medication. | Device | Dose Escalation Cohort 1-5, Dose Expansion (RP2D) |
| DV281 (RP2D)- Dose Expansion will be enrolled into 4 groups based on NSCLC characteristics. | Drug | Dose Expansion (RP2D) |
| Approved Anti-PD-1 InhibitorAlso: nivolumabFDA approved Anti-PD-1 Inhibitor | Drug | Dose Escalation Cohort 1-5, Dose Expansion (RP2D) |
Primary outcome
Dose Escalation
Time frame: DLT assessment period - Day 1 through Day 28.
Incidence of dose-limiting toxicities (DLTs)
Dose Expansion
Time frame: 1 year after last subject is enrolled in the Dose Expansion phase of study
Objective response rate (ORR) of dosing regimen established during the Dose Escalation
Dose Expansion
Time frame: 1 year after last subject is enrolled in the Dose Expansion phase of the Study
Duration of Response (DOR) and time to response.
2 secondary outcomes
Dose Escalation
Time frame: IFN response assessment period - Day 1 through Day 21
Dose Expansion
Time frame: 1 year after last subject is enrolled in the Dose Expansion phase of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Garon, MD principal investigator
University of California, Los Angeles
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DV281, Breath Actuated Nebulizer and DV281 (RP2D) in people with Advanced Non Small Cell Lung Cancer, run by Dynavax Technologies Corporation at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation (time frame: DLT assessment period - Day 1 through Day 28.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.