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Protocol No. UW17064

Principal Investigator Leal, Ticiana

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase II, Multi-center, Open Label Study of NIR-178 in Combination with PDR001 in Patients with Selected Advanced Solid Tumors and Non-Hodgkin Lymphoma

Objective The purpose of this study is to determine if the combination of NIR-178 and PDR001 is safe and effective in patients with selected advanced solid tumors and Non-Hodgkin. NIR-178 is being developed as a new class of treatment that boosts the immune system’s ability to detect and fight various forms of cancer. When NIR-178 binds to its corresponding receptor, (the adenosine A2A receptor), it may prevent cancer growth by helping the immune system identify and eliminate the tumor.
The other investigational drug, PDR001, is an antibody. PDR001 blocks a protein called PD-1, which is found on specific white blood cells called T- lymphocytes. T-lymphocytes are white blood cells that are involved in the immune response. By blocking PD-1, PDR001 may increase the activity of T-lymphocytes which may reduce the growth of tumors. This study is divided into three parts. Depending on the type of the disease, patient's will be assigned to one of the three parts of the study.

Treatment NIR-178 given orally twice daily either continuously or intermittent in combination with PDR001 intravenously every 4 weeks

Description A phase 2, multi-center, open label study with NIR-178 in combination with PDR001 in patients with selected advanced solid tumors and Non-Hodgkin lymphoma

Key Eligibility
  • Adult patients (≥ 18 years) with advanced or metastatic solid tumors or lymphomas
  • Histologically documented advanced or metastatic solid tumors or lymphomas
  • Patient must be willing to undergo a new tumor biopsy at screening, and again during therapy
  • Must have a site of disease amenable to biopsy
    Head & Neck Squamous Cell Carcinoma (HNSCC):
  • I/O Naive HNSCC:
  • Patients with HNSCC with no more than 3 prior lines of therapy
  • Patient must have received a prior platinum-containing regimen and have not been previously treated with any anti-PD1/L1 agents in single agent/combinations
    I/O pre-treated HNSCC:
  • Patients with HNSCC with no more than 2 prior lines of therapy. Patient must have received a prior platinum-containing regimen and have been pretreated with an anti-PD-1/PD-L1 as a single agent or in combinations
  • Patients must not have received prior immunotherapy
  • Must have measurable disease
  • ECOG performance status of 0-2
  • Must have adequate hematology, liver and renal function
  • No prior symptomatic or uncontrolled brain metastases requiring concurrent treatment
  • No prior history of another primary malignancy
  • No active or prior documented autoimmune disease within the past 2 years
  • No active or prior documented inflammatory bowel disease
  • No history of interstitial lung disease or non-infectious pneumonitis
  • No history of primary immunodeficiency
  • No history of allogeneic organ or stem cell transplant
  • No known history of previous clinical diagnosis of tuberculosis
  • No history of leptomeningeal carcinomatosis
  • Can not be pregnant or nursing (lactating)
  • No smoking at least 7 days prior to starting on therapy
  • No significant cardiac disease

  • Applicable Disease Sites Bladder; Breast; Colon and Rectum; Esophagus; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Lung; Lymphoma; Melanoma/Skin cancer; Pancreas; Thyroid; Unknown Sites

    Status Open

    Participating Institutions UW Hospital and Clinics