Clinical trial · Interventional
Evaluating Combination Therapy Using Autologous Dendritic Cells Pulsed With Antigen Peptides and Nivolumab for Subjects With Advanced Non-Small Cell Lung Cancer
Evaluating Combination Therapy Using Autologous Dendritic Cells Pulsed With Antigen Peptides and Nivolumab for Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT04199559CI-TRIAL-00042310unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous dendritic cells pulsed with antigen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous dendritic cells pulsed with antigen
- 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.
- interventionNames
- Drug: Autologous dendritic cells pulsed with antigen
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- up to 2 year
- description
- From date of randomization until the date of first documented progression or date of death from any cause
Secondary outcomes (3)
- measure
- Objective response rate (ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.