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Protocol No. UW17138

Principal Investigator Kyriakopoulos, Christos

Phase II (Cancer Control)

Age Group Adult

Scope National

Sponsor Type Industry; Institutional

Title Phase II study of Optimized Management of NIVOlumab based on REsponse in patients with advanced renal cell carcinoma (OMNIVORE study)

Objective We want to find out if two drugs, called nivolumab and ipilimumab, can stop or slow advanced renal cell carcinoma. We also want to find out if nivolumab and ipilimumab are safe to use to treat renal cell carcinoma. The combination of these two drugs is investigational. This means that the US Food and Drug Administration (FDA) has not approved the way nivolumab and ipilimumab are being given in this study, even though they are each FDA approved for other uses.

Treatment Prior to starting treatment, you will have a biopsy. Once on treatment, everyone on this study will receive nivolumab intravenously in two 28-day “courses.” In each course, you receive nivolumab every 2 weeks for 4 weeks; after 8 weeks, you will have a scan to find out how the cancer is responding.
Depending on what the scan shows the response of your disease to be, you will be placed in one of two groups: Arm A or Arm B:
  • Arm A: If the scan shows that your disease is improving, you will stop receiving nivolumab, and will have scans every 8 weeks. If your disease gets worse, you will begin to get nivolumab again
  • Arm B: If the scan shows that your disease has stayed the same or gotten worse, you will receive nivolumab and ipilimumab. Both will be given intravenously every 3 week

  • Description A phase 2 study of nivolumab in renal cell carcinoma

    Key Eligibility
  • Greater than 18 years of age, ECOG performance status of 0-2
  • Unresectable advanced or metastatic RCC to include both clear cell and non-clear histologies
  • Availability at the study site of formalin-fixed, paraffin-embedded (FFPE) archival tumor specimens, when available, and willingness of the subject to undergo mandatory fresh tumor biopsy prior to treatment initiation unless determined medically unsafe or not feasible
  • Previously untreated or treated subjects with no limit on prior lines of systemic therapies are allowed
  • Measurable disease as defined by Response Evaluation Criteria In Solid Tumors RECIST 1.1
  • Adequate organ function
  • Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception
    EXCLUSION:
  • Prior use of systemic checkpoint inhibitors for the management of metastatic RCC is excluded. Prior IFN-α or IL-2 is allowed
  • Treatment with systemic immunosuppressive medications
  • Treatment with a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor (e.g. denosumab) within 2 weeks of first study dose
  • Known active metastases to the brain, spinal cord or leptomeninges unless adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks of first study treatment as documented by magnetic resonance imaging (MRI) or computerized tomography (CT) imaging and having no ongoing requirement for steroids
  • Uncontrolled adrenal insufficiency
  • History of idiopathic pulmonary fibrosis, organized pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
  • Known active or chronic hepatitis B infection
  • Active hepatitis C infection
  • Signs and symptoms of infection within 2 weeks of first study treatment. Receipt of therapeutic oral or IV antibiotics within 2 weeks of first study treatment. Subjects receiving routine antibiotic prophylaxis (for dental extractions/procedures) are eligible
  • Significant cardiovascular disease
  • Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on screening EKG > 480 msec
  • History of abdominal or tracheoesophageal fistula or GI perforation
  • Prior allogenic stem cell or solid organ transplant
  • Serious, non-healing or dehiscing wound or active ulcer

  • Applicable Disease Sites Kidney

    Status Open

    Participating Institutions UW Hospital and Clinics