Phase Ib Study to Test the Feasibility and Safety of a Personalized Vaccine in Combination With Low-dose Cyclophosphamide in Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)

NCT05195619 Phase 1 ACTIVE_NOT_RECRUITING

Phase Ib clinical trial using autologous dendritric cell (DC) vaccine loaded with personalized peptides (PEP) given in combination with low-dose cyclophosphamide, as standard of care (SOC) therapy in patients with advanced or recurrent metastatic NSCLC.

Details

Lead sponsor	Centre Hospitalier Universitaire Vaudois
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	16
Start date	2022-03-22
Completion	2027-06

Conditions

• Non-small Cell Lung Cancer

Interventions

• Autologous dendritic cell vaccine loaded with personalized peptides (PEP-DC vaccine)
• Low dose cyclophosphamide

Primary outcomes

• Number of patients who receive at least one dose of vaccine — 3.5 years after study activation
  Feasibility will be evaluated by the number of patients who receive at least one dose of vaccine, among all enrolled patients.
• Assessment of adverse events — from informed consent form (ICF) signature until 30 days after last injection of DC vaccine/cyclophosphamide
  Safety will be assessed by recording all adverse events (AEs) observed from informed consent form (ICF) signature until 30 days after last injection of DC vaccine/cyclophosphamide.
• Assessment of treatment-limiting toxicities — 21 days (i.e. during the full vaccination period)
  Collection of events defined as related to vaccine administration. Patients showing any of them will be withdrawn from the study.

Countries

Switzerland