Clinical Trial for subjects with advanced melanoma, non–small cell lung cancer (NSCLC), pancreatic cancer, or squamous cell carcinoma of the head and neck (SCCHN).

What we are studying

You are invited to join voluntarily in a clinical research study to find out if the drugs INCB024360 and MEDI4736 (Study Drugs) are safe and have beneficial effects when given together in people who have selected types of cancer. INCB024360 is an investigational drug that is being developed by Incyte Corporation (the Sponsor of this research Study) for the treatment of selected types of cancer. MEDI4736 is an investigational drug that is being developed by Medimmune as a treatment for advanced cancer. “Investigational” means that the drug has not been approved by US Food and Drug Administration (FDA) for general use as a prescription or over-the-counter medication. INCB024360 and MEDI4736 are both treatments designed to help your immune system (the part of your body that fights infections and cancer). By making your immune system more active, we hope to help your body fight your cancer. These drugs both help your immune system but they work in different ways. INCB024360 is a chemical drug that stops a protein (also called an enzyme) in your body called indoleamine-2,3-dioxygenase-1 (IDO1). This protein plays a role in blocking your immune system. MEDI4736 is designed to improve the immune system’s ability to recognize and destroy cancer cells by targeting a protein in your body called Programmed death ligand 1 (PD-L1). In cancer, immunotherapies are increasingly being investigated or used to boost the body’s immune system so that cancer cells are recognized and destroyed. We hope these treatments result in the cancer shrinking and the person being treated living longer.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Participants must have confirmed diagnosis of melanoma
  • Non-Small cell lung cancer
  • Pancreatic cancer
  • Or squamous cell carcinoma of the head and neck that is locally advanced or metastatic. Participants must have failed at least 1 prior treatment regimen. Participants with melanoma must consent to genetic mutation testing of their tumor tissue. Participants with lung cancer and squamous cell carcinoma must have failed prior treatment with platinum-based chemotherapy.

What is involved

  • Administration of Study drugs INCB024360 (oral administration every 12 hrs) in combination with MEDI4736 (IV administration every 14 days)
  • Blood draws for: CBC
  • Chemistry
  • Liver panel
  • Coagulation panel
  • Endocrine function testing
  • Hep B/C testing
  • Serum/Urine pregnancy test
  • Pharmacodynamics/Pharmacokinetic tests
  • Soluble PD-L1
  • Immunogenicity testing
  • Tumor markers; tumor imaging via CT/MRI scans every 8 weeks
  • Vital signs and weight
  • 12-Lead ECG
  • 3 hr post-infusion observation on cycle 1 day 1
  • Pulmonary function test and chest radiograph at screening
  • Tumor tissue biopsy.

Compensation

None

Contact Information

Study Coordinator
Scarlett Hutchens
Email
snhutche@wakehealth.edu
Phone
336-713-6915
Principal Investigator
Pierre Triozzi, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.