An Open-label, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MEDI9253, a Recombinant Newcastle Disease Virus Encoding Interleukin-12, in Combination with Durvalumab in Participants with

Contact:

NCT Number:

Protocol:

AAAT2505

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I

The purpose of this study is to find out if two drugs, MEDI9253 and durvalumab, will be safe for the treatment of solid tumors. MEDI9253 and durvalumab are types of cancer therapies that try to boost the immune system to fight cancer. MEDI9253 is an oncolytic virus (a virus that infects and breaks down cancer cells but not normal cells) and may also help the immune system recognize cancer cells to destroy. MEDI9253 is an experimental drug. This means that is has not been approved for treatment by any regulatory authority that regulates new medicines, such as the U.S. Food and Drug Administration (FDA).

Are you Eligible? (Inclusion Criteria)

  • 18 years of age or older
  • Participants must have received and progressed, are refractory or are intolerant to standard therapy for microsatellite stable [MSS] colorectal cancer [CRC], renal cell carcinoma [RCC], or melanoma.
  • Participants must have a life expectancy of at least 12 weeks

Specialty Area(s)

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032