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History of Changes for Study: NCT02811861
Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
Latest version (submitted July 7, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 21, 2016 None (earliest Version on record)
2 September 15, 2016 Study Status
3 September 28, 2016 Recruitment Status, Study Status, Contacts/Locations, Eligibility and Oversight
4 October 17, 2016 Contacts/Locations, Eligibility and Study Status
5 March 21, 2017 Study Status, Contacts/Locations, Eligibility and Outcome Measures
6 June 22, 2017 Contacts/Locations, Outcome Measures, Study Status and Eligibility
7 July 24, 2017 Study Status
8 December 12, 2017 Contacts/Locations, Study Status, Study Design and Oversight
9 January 26, 2018 Contacts/Locations, Study Status and Study Design
10 April 5, 2018 Contacts/Locations, Study Identification, Outcome Measures, Study Status and Eligibility
11 June 13, 2018 Contacts/Locations and Study Status
12 September 12, 2018 Study Status, Outcome Measures, Eligibility and Study Design
13 September 20, 2018 Study Status
14 September 28, 2018 Study Design and Study Status
15 December 19, 2018 Study Status and Contacts/Locations
16 January 7, 2019 Study Status
17 January 17, 2019 Contacts/Locations and Study Status
18 January 29, 2019 Contacts/Locations and Study Status
19 February 1, 2019 Contacts/Locations and Study Status
20 July 31, 2019 Contacts/Locations and Study Status
21 August 21, 2019 Recruitment Status, Contacts/Locations, Study Status and Study Design
22 March 27, 2020 Study Status and Outcome Measures
23 July 30, 2020 Study Design and Study Status
24 November 18, 2020 Study Status
25 April 23, 2021 Study Status and Study Design
26 June 17, 2021 Study Status and Sponsor/Collaborators
27 August 27, 2021 Contacts/Locations, Outcome Measures, Study Status, Document Section, Results and Study Identification
28 February 9, 2022 Arms and Interventions, Study Status, Contacts/Locations, Eligibility, Study Description and Oversight
29 July 1, 2022 Study Status
30 July 7, 2023 Study Status
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Study NCT02811861
Submitted Date:  June 21, 2016 (v1)
Open or close this module Study Identification
Unique Protocol ID: E7080-G000-307
Brief Title: Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
Official Title: 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.
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2016
Overall Status: Not yet recruiting
Study Start: September 2016
Primary Completion: November 2020 [Anticipated]
Study Completion: November 2022 [Anticipated]
First Submitted: June 21, 2016
First Submitted that
Met QC Criteria:		 June 21, 2016
First Posted: June 23, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:		 June 21, 2016
Last Update Posted: June 23, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Eisai Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Renal Cell Carcinoma
Keywords: Renal Cell Carcinoma (RCC)
Lenvatinib
First-line RCC
Treatment-naive RCC
Everolimus
Pembrolizumab
Sunitinib
Phase 3 RCC
Phase 3 first-line RCC
Phase 3 treatment-naive RCC
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 735 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Lenvatinib 18 mg plus everolimus 5 mg
Lenvatinib 18 milligrams (mg) administered orally, once daily, plus everolimus 5 mg administered orally, once daily
 Drug: lenvatinibDrug: everolimus
Experimental: Lenvatinib 20 mg plus pembrolizumab 200 mg
Lenvatinib 20 mg administered orally, once daily, plus pembrolizumab 200 mg administered intravenously (IV), every 3 weeks
 Drug: lenvatinibDrug: pembrolizumab
Active Comparator: Sunitinib 50 mg
Sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment
 Drug: Sunitinib
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression-free Survival (PFS)
[ Time Frame: up to approximately 37 months ]
Secondary Outcome Measures:
1. Objective response rate (ORR)
[ Time Frame: up to approximately 37 months ]
2. Overall survival (OS)
[ Time Frame: up to approximately 37 months ]
3. Number of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
[ Time Frame: up to approximately 37 months ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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:

  • Subjects who have received any systemic anticancer therapy for RCC, including anti-vascular endothelial growth factor (VEGF) therapy, or any systemic investigational anticancer agent
  • Subjects 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 brain 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. Subjects 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
  • Subjects 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 subjects 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 subjects 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 subjects at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels (eg, carotid artery) 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 6 months of the first dose of study drug: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke, cardiac arrhythmia associated with significant cardiovascular impairment, or a left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multiple gated acquisition scan (MUGA) or echocardiogram
  • Active infection (any infection requiring systemic treatment)
  • Human Immunodeficiency Virus (HIV) positive
  • 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 or active non-infectious pneumonitis
  • Subjects with a diagnosis of immunodeficiency or who are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. The use of physiologic doses of corticosteroids (up to 7.5 mg/day of prednisone or equivalent) may be approved after consultation with the sponsor
  • 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
Open or close this module Contacts/Locations
Central Contact Person: Eisai Medical Information
Telephone: 1-888-274-2378
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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