Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
With
Merck Sharp & Dohme LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed written informed consent before performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
Diagnosis of locally advanced or metastatic RCC that is predominantly clear cell histology
Must have measurable disease
Subject has received no prior systemic therapy
A woman is eligible to participate in the study if she is of Non-childbearing potential, has a negative serum pregnancy test within 7 days of the first dose of study treatment, not lactating, and agrees to use adequate contraception during the study until at least 120 days after the last dose of investigational product
Eastern Cooperative Oncology Group performance status 0 or 1
Adequate organ function as defined in the protocol
Left ventricular ejection fraction \>= lower limit of normal as assessed by echocardiogram or multigated acquisition scan
In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
You may not be if
Subject has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
Subject is currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study treatment
Subject is expected to require any other form of systemic or localized antineoplastic therapy while on study
Subject is on any systemic steroid therapy, within one week before the planned date for first dose of study treatment. Subject is on any other form of immunosuppressive medication
Subject has a history of a malignancy (other than the disease under treatment in the study) within 5 years before first study treatment administration
Central nervous system metastasis
Unable to swallow and retain orally administered medication
Subject has interstitial lung disease or a history of pneumonitis
Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other Gastrointestinal conditions with increased risk of perforation; history of abdominal fistula, GI perforation, or intra-abdominal abscess within 4 weeks before beginning study treatment
Known history of HIV infection or a known history of or is positive for Hepatitis B or Hepatitis C
Presence of active infection requiring systemic therapy
Corrected QT interval duration prolongation
History of any one or more of the following cardiac conditions within the past 6 months: Cardiac angioplasty or stenting; Myocardial infarction; Unstable angina; History of Class III or IV congestive heart failure according to New York Heart Association classification
History of cerebrovascular accident within the past 6 months
Poorly controlled hypertension
History of untreated deep venous thrombosis
Presence of any non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease
Evidence of bleeding diathesis or coagulopathy
Recent hemoptysis
Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage
Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures
Previous severe hypersensitivity reaction to another Monoclonal antibody. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the excipients in pazopanib tablets
Has taken any prohibited medications that are listed in the protocol within 14 days of the first dose of study treatment. Subject has received or will receive a live vaccine within 30 days before the first administration of study treatment
Clareo Health | Safety and Efficacy Study of Pazopanib and MK 3475 in Advanced Renal Cell Carcinoma (RCC; KEYNOTE-018)
