Clinical Trial for subjects with non-small cell lung cancer, melanoma, colorectal cancer, squamous cell carcinoma of the head and neck, B-cell Non-Hodgkin lymphoma, or Hodgkin Lymphoma, or Glioblastoma

What we are studying

You are invited to join voluntarily in a clinical research study to find out if the investigational drug INCB024360 is safe and has beneficial effects when given with nivolumab in people who have advanced or metastatic solid tumors or certain tumor types. INCB024360 and nivolumab 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. Nivolumab is a monoclonal antibody, which is called a biological drug. Monoclonal antibodies are large proteins made by your body or they can be artificially created in a laboratory. Nivolumab is artificially created. It binds to and blocks a protein in your body called Programmed cell death protein 1 (PD-1). Blocking both IDO1 and PD-1 may help the body’s immune system fight your cancer. 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

  • Study participants must be able to comprehend and sign the consent form.
  • They must have histologically or cytologically confirmed non-small cell lung cancer; melanoma; colorectal cancer; squamous cell carcinoma of the head and neck; recurrent B cell Non-Hodgkin lymphoma; or Hodgkin Lymphoma; or glioblastoma.
  • Fresh baseline tumor biopsies are required for all cancer types except glioblastoma.
  • Female subjects must not be pregnant or breast-feeding while receiving study treatment.
  • Subjects must not be participating in any other study in which receipt of an investigation study drug occurred within 28 days of the 1st dose of investigational drug on this trial.
  • Use of inhaled or topical steroids or systemic corticosteroids < 7.5 mg is permitted.

What is involved

  • Informed consent
  • Review of inclusion/exclusion criteria
  • Prior medical and cancer history
  • Concomitant medications review
  • Comprehensive physical exam
  • Targeted physical exam
  • ECOG performance status
  • Assessment for serotonin syndrome
  • Vital signs/weight/height
  • O2 saturation
  • Pulmonary function test
  • 12-Lead ECG
  • Laboratory assessments including: chemistry
  • Hematology
  • Liver function tests
  • Coagulation panel
  • Endocrine function testing
  • Urinalysis
  • Serum pregnancy test
  • Urine pregnancy test
  • Serology for HBV/HCV
  • PK assessments for INCB024360 and nivolumab
  • Immunogenicity assessments for nivolumab
  • Serum for soluble PD-1/nivolumab PD
  • Blood for genotyping and future biomedical research
  • Whole blood PD for INCB024360
  • Whole blood correlative studies PD collection
  • Plasma PD collection
  • Whole blood with optional tumor biopsy for correlative studies
  • HPV status
  • Microsatellite instability testing
  • Collection of archived or fresh tumor tissue
  • Radiologic tumor assessments via MRI
  • CT or PET at screening then every 8 weeks
  • Bone marrow examination as applicable to disease
  • Oral twice daily administration of INCB024360
  • IV administration of nivolumab every 2 weeks
  • Review of subject reminder cards and drug log
  • And post-study anticancer therapy status.


Subjects will be reimbursed a minor predetermined amount for travel expenses based on the result of budget negotiations with the Sponsor.

Contact Information

Study Coordinator
Stacey Lewis
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.