Personalized Neoantigen Vaccine in Combination With Durvalumab (MEDI4736) in Extensive Stage Small Cell Lung Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

March 30, 2022

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2029

Conditions
Extensive-stage Small Cell Lung Cancer
Interventions
BIOLOGICAL

Neoantigen DNA vaccine

All study injections will be given intramuscularly using an integrated electroporation device (TDS-IM system, PapiVax Biotech). At each vaccination time point, patients will receive two injections of the neoantigen DNA vaccine, one injection into each deltoid or lateralis.

DRUG

Durvalumab

-Supplied by AstraZeneca

DEVICE

TDS-IM v2.0 Device

-Integrated electroporation administration system

PROCEDURE

Peripheral blood draws

-Pre-treatment, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Vaccine Day 1, Vaccine Day 29, Vaccine Day 85, Vaccine Day 141, on even numbers of cycles for durvalumab for one year following completion of vaccine

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Gateway for Cancer Research

OTHER

lead

Washington University School of Medicine

OTHER