Clinical trial NCT04199559: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: NSCLC
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Cttq
First posted: 2019-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: up to 2 year
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: up to 1 year
measure: Disease Control Rate (DCR)
timeFrame: up to 1 year
measure: Overall survival(OS)
timeFrame: up to 2 year
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Zibing Wang
role: PRINCIPAL_INVESTIGATOR
References: