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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT04397003
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Extensive-stage Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neoantigen DNA vaccine — BIOLOGICAL
    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.
  • Durvalumab — DRUG
    -Supplied by AstraZeneca
  • TDS-IM v2.0 Device — DEVICE
    -Integrated electroporation administration system
  • Peripheral blood draws — PROCEDURE
    -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

Study Details

The investigators hypothesize that a personalized neoantigen vaccine combined with durvalumab will improve the progression free survival of patients with extensive state small cell lung cancer (ES-SCLC).

Key Dates

Start date
Mar 30, 2022
Status verified
Oct 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2029

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoantigen DNA vaccine+durvalumab
    * Patients will receive durvalumab (1500mg Q3W) in combination with standard of care carboplatin and etoposide for a total of 4 cycles given every 3 weeks * Beginning 4 weeks following Cycle 4 of carboplatin/etoposide/durvalumab, patients on will then receive 6 cycles of durvalumab 1500 mg with the polyepitope neoantigen DNA vaccine, both administered once every 4 weeks * Patients may then receive durvalumab every 4 weeks until disease progression or drug toxicity * Should a delay in vaccine preparation occur, patients will begin durvalumab and the vaccine will be added with the subsequent cycle.

Primary Outcome Measure

Safety and tolerability of the combination of durvalumab and a neoantigen vaccine as measured by number of participants experiencing adverse events [ Time Frame: Through 90 days after completion of treatment (estimated to be 2 years and 3 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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Washington University School of Medicine· St Louis, MO

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