Safety and Efficacy Study of Pazopanib and MK 3475 in Advanced Renal Cell Carcinoma (RCC; KEYNOTE-018)



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/8/2018
Start Date:December 27, 2013
End Date:April 17, 2019

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A Phase I/II Study to Assess the Safety and Efficacy of Pazopanib and MK 3475 in Patients With Advanced Renal Cell Carcinoma

This is an open-label, 2 part study of pazopanib and/or MK 3475 in treatment naïve subjects
with advanced RCC. Part 1 consists of a Phase I dose escalation of pazopanib + MK 3475
followed by an expansion cohort to determine the maximum tolerated regimen and the
recommended Phase II dose. Part 2 is a randomized 3-arm Phase II study to evaluate the
clinical efficacy and safety of pazopanib + MK 3475 as compared to single-agent pazopanib and
single-agent MK 3475. The objectives of this Phase I/II study are to test the safety and
tolerability of pazopanib in combination with MK 3475, and study the clinical efficacy of
pazopanib in combination with MK 3475 in subjects with advanced RCC as compared with
single-agent pazopanib and single-agent MK 3475.

Following the Urgent Safety Measure (USM) released on February 09, 2017, the phase II (Part
2) portion of this study will not commence.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
5
sites
230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Boston, Massachusetts 02118
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Boston, Massachusetts 02118
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Manchester, Lancashire
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Nashville, Tennessee 37205
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