Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:October 13, 2016
End Date:February 26, 2021
Contact:Eisai Medical Information
Email:esi_oncmedinfo@eisai.com
Phone:1-888-274-2378

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A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects With Advanced Renal Cell Carcinoma (CLEAR)

This is a multicenter, randomized, open-label, Phase 3 study to compare the efficacy and
safety of lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) versus
sunitinib (Arm C) as first-line treatment in participants with advanced renal cell carcinoma.


Inclusion Criteria:

- Histological or cytological confirmation of renal cell carcinoma (RCC) with a
clear-cell component

- At least 1 measurable target lesion according to Response Evaluation in Solid Tumors
(RECIST) 1.1

- Karnofsky Performance Status (KPS) of ≥70

- Adequately controlled blood pressure (BP) with or without antihypertensive
medications, defined as BP ≤150/90 mmHg at Screening and no change in antihypertensive
medications within 1 week prior to Cycle 1/Day 1 (C1/D1)

- Adequate organ function per blood work

Exclusion Criteria:

- Participants who have received any systemic anticancer therapy for RCC, including
anti-vascular endothelial growth factor (VEGF) therapy, or any systemic
investigational anticancer agent

- Participants with central nervous system (CNS) metastases are not eligible, unless
they have completed local therapy (eg, whole brain radiation therapy (WBRT), surgery
or radiosurgery) and have discontinued the use of corticosteroids for this indication
for at least 4 weeks before starting treatment in this study. Any signs (eg,
radiologic) or symptoms of CNS metastases must be stable for at least 4 weeks before
starting study treatment

- Active malignancy (except for RCC, definitively treated basal or squamous cell
carcinoma of the skin, and carcinoma in-situ of the cervix or bladder) within the past
24 months. Participants with history of localized & low risk prostate cancer are
allowed in the study if they were treated with curative intent and there is no
prostate specific antigen (PSA) recurrence within the past 5 years

- Prior radiation therapy within 21 days prior to start of study treatment with the
exception of palliative radiotherapy to bone lesions, which is allowed if completed 2
weeks prior to study treatment start

- Received a live vaccine within 30 days of planned start of study treatment

- Participants with urine protein ≥1 gram/24 hour

- Fasting total cholesterol >300 milligram per deciliter (mg/dL) (or ˃7.75 millimole per
liter (mmol/L)) and/or fasting triglycerides level ˃2.5 x upper limit of normal (ULN).
Note: these participants can be included after initiation or adjustment of
lipid-lowering medication

- Uncontrolled diabetes as defined by fasting glucose >1.5 times the ULN. Note: these
participants can be included after initiation or adjustment of glucose-lowering
medication

- Prolongation of corrected QT (QTc) interval to >480 milliseconds (ms)

- Bleeding or thrombotic disorders or participants at risk for severe hemorrhage. The
degree of tumor invasion/infiltration of major blood vessels should be considered
because of the potential risk of severe hemorrhage associated with tumor
shrinkage/necrosis following lenvatinib therapy

- Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first
dose of study drug

- Significant cardiovascular impairment within 12 months of the first dose of study
drug: history of congestive heart failure greater than New York Heart Association
Class II, unstable angina, myocardial infarction, cerebrovascular accident, or cardiac
arrhythmia associated with hemodynamic instability. The following is also excluded:
left ventricular ejection fraction below the institutional normal range as determined
by multiple-gated acquisition scan or echocardiogram

- Active infection (any infection requiring systemic treatment)

- Participants known to be positive for Human Immunodeficiency Virus (HIV).

- Known active Hepatitis B (eg, Hepatitis B surface antigen (HBsAg) reactive) or
Hepatitis C (eg, hepatitis C virus ribonucleic acid (HCV RNA) [qualitative] is
detected)

- Known history of, or any evidence of, interstitial lung disease

- Has a history of (non-infectious) pneumonitis that required steroids, or current
pneumonitis

- Participants with a diagnosis of immunodeficiency or who are receiving chronic
systemic steroid therapy (doses exceeding 10 mg/day of prednisone equivalent) or any
other form of immunosuppressive therapy within 7 days prior to the first dose of study
treatment. Physiologic doses of corticosteroids (up to 10 mg/day of prednisone or
equivalent) may be used during the study

- Active autoimmune disease (with the exception of psoriasis) that has required systemic
treatment in the past 2 years (ie, with use of disease modifying agents,
corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine,
insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency) is not considered a form of systemic treatment.

- Known intolerance to any of the study drugs (or any of the excipients)

- Participant has had an allogenic tissue/solid organ transplant.
We found this trial at
45
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Minneapolis, Minnesota 55405
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800 8th Street
Boca Raton, Florida 33486
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
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Asheville, NC
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6420 Rockledge Drive
Bethesda, Maryland 20817
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Boston, Massachusetts 02114
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Box Hill, Victoria
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Buffalo, New York 14263
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Camden, New Jersey 08103
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Columbus, Georgia 31904
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Dallas, Texas 75246
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Detroit, Michigan 48202
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Dublin, Georgia 31021
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Fort Worth, Texas 76104
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Hackensack, New Jersey 07601
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Johnson City, New York 13790
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McAllen, Texas 78503
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Miami Beach, Florida 33140
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Nashville, Tennessee 37203
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New Orleans, Louisiana 70121
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Niles, Illinois 60714
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Omaha, Nebraska 68130
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Omaha, Nebraska 68114
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Orlando, Florida 32804
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12140 Nall Avenue
Overland Park, Kansas 66209
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Palo Alto, California 94304
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Paris, Texas 75460
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1201 5th Avenue North
Saint Petersburg, Florida 33705
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Stanford, California 94305
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Tinley Park, Illinois 60487
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Tyler, Texas 75702
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Wenatchee, Washington 98801
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West Palm Beach, Florida 33401
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