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

NCT04199559 | Unknown Phase 1

• 1 other identifier: 2019111810
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Objective response rate (ORR)

  up to 1 year

• Disease Control Rate (DCR)

  up to 1 year

• Overall survival(OS)

  up to 2 year

Study Arms (1)

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.

Drug: Autologous dendritic cells pulsed with antigen

Interventions

Autologous dendritic cells pulsed with antigen DRUG

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

Autologous dendritic cells pulsed with antigen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• Cttq: collaborator

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Interventions

Antigens

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

• Zibing Wang

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zibing Wang

CONTACT

18937621301; bingziwang@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start: December 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: December 16, 2019

Record last verified: 2019-12

Locations

CN (1)