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

NSCLC Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04199559
• Other study ID #: 2019111810
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: December 2019
• Source: Henan Cancer Hospital
• Contact: Zibing Wang
• Phone: 18937621301
• Email: bingziwang[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Drug:
• Autologous dendritic cells pulsed with antigen
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

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Henan Cancer Hospital	Cttq

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS)	From date of randomization until the date of first documented progression or date of death from any cause	up to 2 year
Secondary	Objective response rate (ORR)	From date of randomization until the date of death from any cause	up to 1 year
Secondary	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.	up to 1 year
Secondary	Overall survival(OS)	From date of randomization until the date of death from any cause	up to 2 year