NSCLCPhase 1/2NCT04199559
Evaluating Combination Therapy Using Autologous Dendritic Cells Pulsed With Antigen Peptides and Nivolumab for Subjects With Advanced Non-Small Cell Lung Cancer
A Phase 1/2 study testing Autologous dendritic cells pulsed with antigen in people with NSCLC, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Study Arms: Patients receive autologous dendritic cells pulsed with antigen peptides ID on days 15, 29, 43,57,71,99,127and 155, and nivolumab IV over 60 minutes on days 15, 29, 43,57,71,85 99 and 113. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Autologous dendritic cells pulsed with antigen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 1 Jan 2022
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 20 years of age or older on day of signing informed consent.
- Non-small cell lung cancer (NSCLC) patient with progression on or after platinum-based chemotherapy.
- Have measurable disease based on Response Evaluation in Solid Tumors (RECIST) 1.1.
- Have a performance status of 0 - 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Life expectancy of >6 months.
- Females of childbearing potential should have a negative urine or serum pregnancy.
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- Serum glutamate pyruvate transaminase (SGPT) =< 4.0 times upper limits of normal (ULN)
- Serum glutamic-oxaloacetic transaminase (SGOT) =< 4.0 times ULN
- Creatinine =< 2 times ULN
- Patients who have one of the following HLA types: A2402, A0201, A0206
- Pre-Leukaphersis evaluation
- Hemoglobin > 10 g/dL (100 g/L)
- White blood cell count 3.0-11.0 x 10^3/mm^3 (3.0-11.0 x 10^9/L)
- Absolute granulocyte count >= 1.5 x 10^3/mm^3 (1.5 x 10^9/L)
- Absolute lymphocyte count >= 1.0 x 10^3/mm^3 (1.0 x 10^9/L)
- Platelet count >= 100 x 10^3/mm^3 (100 x 10^9/L)
Who cannot join
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid or any other form of immunosuppressive therapy.
- Hypersensitivity to nivolumab or any of its excipients.
- Has a known additional malignancy.
- Any diagnosis of autoimmune disease.
- Pregnant or breastfeeding within the projected duration of the trial, starting with screening visit through the last dose of trial treatment.
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- Positive HIV-1, -2, or HTLV-1, -2, tests.
- Positive HBV or HCV tests.
- Positive syphilis tests.
- Recipient of organ allografts.
- Inability or unwillingness to return for required visits and follow-up exams.
- Acute infection: any active viral, bacterial, or fungal infection that requires specific therapy.
- Active uncontrolled infection, such as a sexually transmitted disease (STD), herpes, uncontrolled tuberculosis, malaria, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Zibing Wang
About this study
Official title: Evaluating Combination Therapy Using Autologous Dendritic Cells Pulsed With Antigen Peptides and Nivolumab for Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Arms: Patients receive autologous dendritic cells pulsed with antigen peptides ID on days 15, 29, 43,57,71,99,127and 155, and nivolumab IV over 60 minutes on days 15, 29, 43,57,71,85 99 and 113.
Read the detailed description
Immune checkpoint inhibitors are increasingly drawing much attention in the therapeutic development for cancer treatment. However, many cancer patients do not respond to treatments with immune checkpoint inhibitors, partly because of the lack of tumor-infiltrating effector T cells. DC vaccine may prime patients for treatments with immune checkpoint inhibitors by inducing effector T-cell infiltration into the tumors and immune checkpoint signals. The combination of DC vaccine and an immune checkpoint inhibitor may function synergistically to induce more effective antitumor immune responses, and clinical trials to test the combination are currently needed.
- Conditions
- NSCLC
- Being tested
- Autologous dendritic cells pulsed with antigen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous dendritic cells pulsed with antigenDrug
peptide(WT1-H/K-HELP, Survivin-H/K-HELP,MAGE-A4-H ⁄ K-HELP and MUC1-22) . Each dose contains of 10 million activated autologous DCs. Route of Administration: Intradermal
| Study group | Role | What they receive |
|---|---|---|
| Autologous dendritic cells pulsed with antigen | Experimental | peptide(WT1-H/K-HELP, Survivin-H/K-HELP,MAGE-A4-H ⁄ K-HELP and MUC1-22) . Each dose contains of 10 million activated autologous DCs. Route of Administration: Intradermal. Receives: Drug: Autologous dendritic cells pulsed with antigen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
From date of randomization until the date of first documented progression or date of death from any cause
Measured: up to 2 year
Secondary outcomes (3)
Objective response rate (ORR)
From date of randomization until the date of death from any cause
Measured: up to 1 year
Disease Control Rate (DCR)
Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
Measured: up to 1 year
Overall survival(OS)
From date of randomization until the date of death from any cause
Measured: up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start1 Dec 2019
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Cttq
- Responsible party
- Sponsor
- Investigators
- Zibing Wang, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199559
- Sponsor's protocol ID
- 2019111810
- Status last verified
- Dec 2019
- First submitted
- 12 Dec 2019
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Combination Therapy Using Autologous Dendritic Cells Pulsed With Antigen Peptides and Nivolumab for Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT04199559
- Acronym / sponsor ID
- 2019111810
- Conditions
- NSCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- Cttq
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 16 Dec 2019 (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.
Study Arms: Patients receive autologous dendritic cells pulsed with antigen peptides ID on days 15, 29, 43,57,71,99,127and 155, and nivolumab IV over 60 minutes on days 15, 29, 43,57,71,85 99 and 113.
Detailed description
Immune checkpoint inhibitors are increasingly drawing much attention in the therapeutic development for cancer treatment. However, many cancer patients do not respond to treatments with immune checkpoint inhibitors, partly because of the lack of tumor-infiltrating effector T cells. DC vaccine may prime patients for treatments with immune checkpoint inhibitors by inducing effector T-cell infiltration into the tumors and immune checkpoint signals. The combination of DC vaccine and an immune checkpoint inhibitor may function synergistically to induce more effective antitumor immune responses, and clinical trials to test the combination are currently needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous dendritic cells pulsed with antigen | Experimental | Drug: Autologous dendritic cells pulsed with antigenpeptide(WT1-H/K-HELP, Survivin-H/K-HELP,MAGE-A4-H ⁄ K-HELP and MUC1-22) . Each dose contains of 10 million activated autologous DCs. Route of Administration: Intradermal. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Be 20 years of age or older on day of signing informed consent.
- Non-small cell lung cancer (NSCLC) patient with progression on or after platinum-based chemotherapy.
- Have measurable disease based on Response Evaluation in Solid Tumors (RECIST) 1.1.
- Have a performance status of 0 - 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Life expectancy of >6 months.
Key exclusion criteria (13 listed)
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid or any other form of immunosuppressive therapy.
- Hypersensitivity to nivolumab or any of its excipients.
- Has a known additional malignancy.
- Any diagnosis of autoimmune disease.
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 |
|---|---|---|
| Autologous dendritic cells pulsed with antigenpeptide(WT1-H/K-HELP, Survivin-H/K-HELP,MAGE-A4-H ⁄ K-HELP and MUC1-22) . Each dose contains of 10 million activated autologous DCs. Route of Administration: Intradermal | Drug | Autologous dendritic cells pulsed with antigen |
Primary outcome
Progression-free Survival (PFS)
Time frame: up to 2 year
From date of randomization until the date of first documented progression or date of death from any cause
3 secondary outcomes
Objective response rate (ORR)
Time frame: up to 1 year
Disease Control Rate (DCR)
Time frame: up to 1 year
Overall survival(OS)
Time frame: up to 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
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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.
Zibing Wang principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous dendritic cells pulsed with antigen in people with NSCLC, run by Henan Cancer Hospital at 1 site in China.
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 16 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zibing Wang (18937621301, bingziwang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: up to 2 year). 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 16 Dec 2019.