search
Back to results

Evaluating Combination Therapy Using Autologous Dendritic Cells Pulsed With Antigen Peptides and Nivolumab for Subjects With Advanced Non-Small Cell Lung Cancer

Primary Purpose

NSCLC

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Autologous dendritic cells pulsed with antigen
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSCLC

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be 20 years of age or older on day of signing informed consent.
  2. Non-small cell lung cancer (NSCLC) patient with progression on or after platinum-based chemotherapy.
  3. Have measurable disease based on Response Evaluation in Solid Tumors (RECIST) 1.1.
  4. Have a performance status of 0 - 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
  5. Life expectancy of >6 months.
  6. Females of childbearing potential should have a negative urine or serum pregnancy.
  7. Serum glutamate pyruvate transaminase (SGPT) =< 4.0 times upper limits of normal (ULN)
  8. Serum glutamic-oxaloacetic transaminase (SGOT) =< 4.0 times ULN
  9. Creatinine =< 2 times ULN
  10. Patients who have one of the following HLA types: A2402, A0201, A0206
  11. Pre-Leukaphersis evaluation
  12. Hemoglobin > 10 g/dL (100 g/L)
  13. White blood cell count 3.0-11.0 x 10^3/mm^3 (3.0-11.0 x 10^9/L)
  14. Absolute granulocyte count >= 1.5 x 10^3/mm^3 (1.5 x 10^9/L)
  15. Absolute lymphocyte count >= 1.0 x 10^3/mm^3 (1.0 x 10^9/L)
  16. Platelet count >= 100 x 10^3/mm^3 (100 x 10^9/L)

Exclusion Criteria:

  1. 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.
  2. Has a diagnosis of immunodeficiency or is receiving systemic steroid or any other form of immunosuppressive therapy.
  3. Hypersensitivity to nivolumab or any of its excipients.
  4. Has a known additional malignancy.
  5. Any diagnosis of autoimmune disease.
  6. Pregnant or breastfeeding within the projected duration of the trial, starting with screening visit through the last dose of trial treatment.
  7. Positive HIV-1, -2, or HTLV-1, -2, tests.
  8. Positive HBV or HCV tests.
  9. Positive syphilis tests.
  10. Recipient of organ allografts.
  11. Inability or unwillingness to return for required visits and follow-up exams.
  12. Acute infection: any active viral, bacterial, or fungal infection that requires specific therapy.
  13. Active uncontrolled infection, such as a sexually transmitted disease (STD), herpes, uncontrolled tuberculosis, malaria, etc.

Sites / Locations

  • Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous dendritic cells pulsed with antigen

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
From date of randomization until the date of first documented progression or date of death from any cause

Secondary Outcome Measures

Objective response rate (ORR)
From date of randomization until the date of death from any cause
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.
Overall survival(OS)
From date of randomization until the date of death from any cause

Full Information

First Posted
December 12, 2019
Last Updated
December 12, 2019
Sponsor
Henan Cancer Hospital
Collaborators
Cttq
search

1. Study Identification

Unique Protocol Identification Number
NCT04199559
Brief Title
Evaluating Combination Therapy Using Autologous Dendritic Cells Pulsed With Antigen Peptides and Nivolumab for Subjects With Advanced Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Cancer Hospital
Collaborators
Cttq

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous dendritic cells pulsed with antigen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Autologous dendritic cells pulsed with antigen
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
From date of randomization until the date of first documented progression or date of death from any cause
Time Frame
up to 2 year
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
From date of randomization until the date of death from any cause
Time Frame
up to 1 year
Title
Disease Control Rate (DCR)
Description
Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
Time Frame
up to 1 year
Title
Overall survival(OS)
Description
From date of randomization until the date of death from any cause
Time Frame
up to 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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) Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zibing Wang
Phone
18937621301
Email
bingziwang@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zibing Wang
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zibing Wang

12. IPD Sharing Statement

Learn more about this trial

Evaluating Combination Therapy Using Autologous Dendritic Cells Pulsed With Antigen Peptides and Nivolumab for Subjects With Advanced Non-Small Cell Lung Cancer

We'll reach out to this number within 24 hrs