A phase 1b study of an autologous dendritic cell immunotherapy in combination with anti-programmed death-1 treatment in patients with metastatic non-small-cell lung cancer (DARE-LUNG)

Conditions

metastatic non-small-cell lung cancer

Brief summary

Toxicity as defined by the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v.5.0). Toxicity will be assessed during the interventional treatment phase of the trial from leukapheresis until three months after the last vaccine dose.

Detailed description

Overall response rate (ORR%) based on investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; duration of response; median progression-free survival (mPFS, months); 1-year PFS (%) based on investigator assessment per RECIST 1.1; median overall survival (mOS, months); 1-year OS (%)., Vaccine-induced immune responses as measured by in vitro immunomonitoring tests (antigen-specific T-cell reactivity). Immune responses will be measured after each DC vaccination and at prespecified timepoints during the follow-up period., Success rate (%) of manufacturing sufficient DCs for vaccination, which is defined as the production of DC aliquots for ≥ 3 vaccination rounds., Health-related quality of life by means of the EORTC QLQ-C30 and EORTC QLQ-LC29 questionnaires, measured before and during the interventional treatment phase of the trial.

Related papers

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Interventions

DRUGCarboplatin Accord 10 mg/ml

DRUGconcentraat voor oplossing voor infusie

DRUGPaclitaxel Fresenius Kabi 6 mg/ml concentraat voor oplossing voor infusie

DRUGCisplatine Accord 1 mg/ml concentraat voor oplossing voor infusie

DRUGLIBTAYO 350 mg concentrate for solution for infusion.

DRUGMIDRIX-LUNG-002

DRUGPemetrexed Accord 500 mg powder for concentrate for solution for infusion.

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGPemetrexed Accord 1000 mg powder for concentrate for solution for infusion.

DRUGPemetrexed Accord 100 mg powder for concentrate for solution for infusion.

DRUGCarboplatin Accord 10 mg/ml concentraat voor oplossing voor infusie

DRUGMIDRIX-LUNG-001

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Toxicity as defined by the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v.5.0). Toxicity will be assessed during the interventional treatment phase of the trial from leukapheresis until three months after the last vaccine dose.	—

Secondary

Measure	Time frame
Overall response rate (ORR%) based on investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; duration of response; median progression-free survival (mPFS, months); 1-year PFS (%) based on investigator assessment per RECIST 1.1; median overall survival (mOS, months); 1-year OS (%)., Vaccine-induced immune responses as measured by in vitro immunomonitoring tests (antigen-specific T-cell reactivity). Immune responses will be measured after each DC vaccination and at prespecified timepoints during the follow-up period., Success rate (%) of manufacturing sufficient DCs for vaccination, which is defined as the production of DC aliquots for ≥ 3 vaccination rounds., Health-related quality of life by means of the EORTC QLQ-C30 and EORTC QLQ-LC29 questionnaires, measured before and during the interventional treatment phase of the trial.	—

Measure

Time frame

Overall response rate (ORR%) based on investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; duration of response; median progression-free survival (mPFS, months); 1-year PFS (%) based on investigator assessment per RECIST 1.1; median overall survival (mOS, months); 1-year OS (%)., Vaccine-induced immune responses as measured by in vitro immunomonitoring tests (antigen-specific T-cell reactivity). Immune responses will be measured after each DC vaccination and at prespecified timepoints during the follow-up period., Success rate (%) of manufacturing sufficient DCs for vaccination, which is defined as the production of DC aliquots for ≥ 3 vaccination rounds., Health-related quality of life by means of the EORTC QLQ-C30 and EORTC QLQ-LC29 questionnaires, measured before and during the interventional treatment phase of the trial.

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Countries

Belgium

Outcome results

None listed