search
Back to results

Perioperative Lenvatinib With Pembrolizumab in Patients With Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma

Primary Purpose

Kidney Cancer, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lenvatinib
Lenvatinib Mesylate
Pembrolizumab
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a renal mass consistent with a clinical stage >= T3Nx or TanyN+ or deemed unresectable by surgeon
  • Renal cell carcinoma with clear cell component on pre-treatment biopsy of the primary tumor
  • The participant (or legally acceptable representative if applicable) provides written informed consent and the willingness and ability to comply with all aspects of the protocol
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status =< 1
  • Absolute neutrophil count (ANC) >= 1500/uL (specimens must be collected within 72 hours prior to the start of study treatment)
  • Platelets >= 100 000/uL (specimens must be collected within 72 hours prior to the start of study treatment)
  • Hemoglobin >= 9.0 g/dL (specimens must be collected within 72 hours prior to the start of study treatment) or ≥5.6 mmol/La

Renal:

Creatinine =≤1.5 × ULN OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl)=≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN.

Hepatic:

Total bilirubin=≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN AST (SGOT) and ALT (SGPT)=≤2.5 × ULN (≤5 × ULN for participants with liver metastases)

Coagulation:

International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT)=≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.

ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.

  • Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
  • Creatinine clearance (CrCl) should be calculated per institutional standard.

    • International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x upper limit of normal (ULN) unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (specimens must be collected within 72 hours prior to the start of study treatment)
    • Activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (specimens must be collected within 72 hours prior to the start of study treatment)
    • Serum creatinine =< 1.5 x ULN OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 40 mL/min (>= 0.67 mL/sec) for participant with creatinine levels > 1.5 x institutional ULN (specimens must be collected within 72 hours prior to the start of study treatment)
  • Creatinine clearance (CrCl) calculated per the Cockcroft and Gault formula

    • Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (specimens must be collected within 72 hours prior to the start of study treatment)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (=< 5 x ULN for participants with liver metastases) (specimens must be collected within 72 hours prior to the start of study treatment)
    • All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin [beta-hCG]) at the screening visit and the baseline visit. A pregnancy test needs to be performed within 72 hours of the first dose of study drug. Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception for the entire study period and for 120 days after study discontinuation
    • Male subjects who are partners of women of childbearing potential must use a condom and their female partners of childbearing potential must use a highly effective method of contraception beginning at least 1 menstrual cycle prior to starting study drugs, throughout the entire study period, and for 120 days after the last dose of study drug, unless the male subjects are totally sexually abstinent or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile

Exclusion Criteria:

  • Evidence of metastatic disease on pre-treatment imaging
  • The subject has received of any type of cytotoxic, biologic or other systemic anticancer therapy for kidney cancer
  • The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
  • Excluding the primary tumor leading to enrollment in this study, any other active malignancy (except for localized prostate cancer, definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the bladder or cervix) within the past 24 months
  • Prior treatment with lenvatinib or any agent directed against PD-1, PD-L1 or PD-L2, or another stimulatory or co inhibitory T-cell receptor (e.g. CTLA-4, OX 40, CD137)
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment
  • Subjects having > 1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Subjects with urine protein >= 1 g/24-hour will be ineligible
  • Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
  • The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:

    • Cardiovascular disorders:

      • New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months
      • Uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment
      • Prolongation of corrected QT (QTc) interval to > 480 msec per electrocardiogram (ECG) within 28 days before first dose of study treatment
    • Clinically significant hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g. pulmonary hemorrhage) within 3 weeks prior to the first dose of study drug
    • Serious non-healing wound/ulcer/bone fracture
    • History of organ allograft (subject has had an allogenic tissue/solid organ transplant)
  • Biologic response modifiers (e.g. granulocyte colony-stimulating factor) within 4 weeks before study entry. Chronic erythropoietin therapy is permitted provided that no dose adjustments were made within 2 months before first dose of study treatment
  • Subjects must have recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy
  • Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist are live attenuated vaccines and are not allowed
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has an active infection requiring systemic therapy
  • Has a known history of active Hepatitis B (e.g., hepatitis B surface antigen [HBsAg]) or hepatitis C (e.g., HCV RNA qualitative is detected)
  • Has uncontrolled HIV defined by a CD4+ count < 350 cells/uL, an AIDS-defining opportunistic infection within the last 12 months prior to study enrollment or documented multidrug resistance that prevents effective HIV therapy
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

Sites / Locations

  • Emory University Hospital/Winship Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (lenvatinib, pembrolizumab)

Arm Description

Patients receive lenvatinib PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Objective response rate (complete and partial responses)
Will assess the proportion of patients with a reduction in overall tumor burden from baseline after 12 weeks of treatment with neoadjuvant lenvatinib and pembrolizumab.

Secondary Outcome Measures

Incidence of adverse events (AEs)
Adverse events will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The safety profile of the treatment will be documented and summarized by summary statistics as frequency and percentage for each AE.
Overall survival (OS)
OS will be estimated with the Kaplan-Meier method. The OS of each patient group at specific time points such as 6 months, 1 year, 3 years, etc. and will be also estimated alone with 95% confidence interval (CI).
Disease free survival (DFS)
DFS will be estimated with the Kaplan-Meier method. The DFS of each patient group at specific time points such as 6 months, 1 year, 3 years, etc. and will be also estimated alone with 95% CI.

Full Information

First Posted
May 14, 2020
Last Updated
November 28, 2022
Sponsor
Emory University
Collaborators
Merck Sharp & Dohme LLC, National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04393350
Brief Title
Perioperative Lenvatinib With Pembrolizumab in Patients With Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
Official Title
WINSHIP4955-20: Perioperative Lenvatinib With Pembrolizumab in Patients With Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
August 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Merck Sharp & Dohme LLC, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase II trial studies how well lenvatinib and pembrolizumab before surgery work in treating patients with kidney cancer that has spread from its original site of growth to nearby tissues or lymph nodes but has not spread to other places in the body (non-metastatic). Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lenvatinib and pembrolizumab before surgery may kill more tumor cells.
Detailed Description
PRIMARY OBJECTIVE: I. To assess the objective response rate (complete and partial responses), following the administration of lenvatinib and pembrolizumab for a total of 4 cycles (12 weeks) in patients with locally-advanced, biopsy-proven non-metastatic clear cell renal cell carcinoma (ccRCC) prior to undergoing nephrectomy (partial or radical). SECONDARY OBJECTIVES: I. To assess the safety and tolerability of neoadjuvant lenvatinib plus pembrolizumab in a presurgical population as well as the safety of adjuvant pembrolizumab post-surgery. II. To determine the clinical outcomes including disease-free survival (DFS) and overall survival (OS) of patients with non-metastatic ccRCC treated with neoadjuvant lenvatinib and pembrolizumab and adjuvant pembrolizumab. III. To evaluate surgery-related complications and outcomes as per the Clavien-Dindo classification system. EXPLORATORY OBJECTIVES: I. To evaluate changes in biomarkers of immune activation and gene expression before, during and after treatment. II. To assess the quality of life, frailty and sarcopenia of patients before and after treatment. OUTLINE: Patients receive lenvatinib orally (PO) once daily (QD) on days 1-21 and pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up within 14 days, then every 12 weeks thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (lenvatinib, pembrolizumab)
Arm Type
Experimental
Arm Description
Patients receive lenvatinib PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
E7080, ER-203492-00, Multi-Kinase Inhibitor E7080
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Lenvatinib Mesylate
Other Intervention Name(s)
4-[3-Chloro-4-(N''-cyclopropylureido)phenoxy]7-methoxyquinoline-6-carboxamide Mesylate, E7080, Lenvima, Multi-Kinase Inhibitor E7080
Intervention Description
Given PO
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda, Lambrolizumab, MK-3475, SCH 900475
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Objective response rate (complete and partial responses)
Description
Will assess the proportion of patients with a reduction in overall tumor burden from baseline after 12 weeks of treatment with neoadjuvant lenvatinib and pembrolizumab.
Time Frame
Baseline until end of Cycle 1 (4 Cycles (12 weeks)
Secondary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Description
Adverse events will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The safety profile of the treatment will be documented and summarized by summary statistics as frequency and percentage for each AE.
Time Frame
From treatment phase up to 14 day post treatment
Title
Overall survival (OS)
Description
OS will be estimated with the Kaplan-Meier method. The OS of each patient group at specific time points such as 6 months, 1 year, 3 years, etc. and will be also estimated alone with 95% confidence interval (CI).
Time Frame
Up to 4 years after study start
Title
Disease free survival (DFS)
Description
DFS will be estimated with the Kaplan-Meier method. The DFS of each patient group at specific time points such as 6 months, 1 year, 3 years, etc. and will be also estimated alone with 95% CI.
Time Frame
From time of surgery to the first tumor recurrence, or death, assessed up to 4 years
Other Pre-specified Outcome Measures:
Title
Biomarker analysis
Description
Paired t-test or Wilcoxon singed-rank test will be used to compare the biomarkers change before, during, and after treatment.
Time Frame
Up to 4 years after study start
Title
Quality of life: Functional Assessment of Cancer Therapy-Kidney Specific Index-19 questionnaire
Description
QOL will be assessed using the Functional Assessment of Cancer Therapy-Kidney Specific Index-19 (FKSI-19) questionnaire. Summary statistics will be applied to all items in the measurements for quality of life. The KSI-19 is an experimental end point. The minimum and maximum values and whether higher scores mean a better or worse outcome will be determined once data is collected.
Time Frame
Up to 4 years after study start
Title
Fried Frailty Score
Description
Will be assessed using the using the Fried Frailty score. Summary statistics will be applied to all items in the measurements for frailty. The Fried Frailty Score is an experimental end point. The minimum and maximum values and whether higher scores mean a better or worse outcome will be determined once data is collected.
Time Frame
Up to 4 years after study start
Title
Degree of sarcopenia
Description
Will assess pre-and post-treatment imaging via SliceOmatic version (V) 5.0 by TomoVision program. Summary statistics will be applied to all items in the measurements for degree of sarcopenia.
Time Frame
Up to 4 years after study start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a renal mass consistent with a clinical stage >= T3Nx or TanyN+ or deemed unresectable by surgeon Renal cell carcinoma with clear cell component on pre-treatment biopsy of the primary tumor The participant (or legally acceptable representative if applicable) provides written informed consent and the willingness and ability to comply with all aspects of the protocol Have an Eastern Cooperative Oncology Group (ECOG) performance status =< 1 Absolute neutrophil count (ANC) >= 1500/uL (specimens must be collected within 72 hours prior to the start of study treatment) Platelets >= 100 000/uL (specimens must be collected within 72 hours prior to the start of study treatment) Hemoglobin >= 9.0 g/dL (specimens must be collected within 72 hours prior to the start of study treatment) or ≥5.6 mmol/La Renal: Creatinine =≤1.5 × ULN OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl)=≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN. Hepatic: Total bilirubin=≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN AST (SGOT) and ALT (SGPT)=≤2.5 × ULN (≤5 × ULN for participants with liver metastases) Coagulation: International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT)=≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants. ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks. Creatinine clearance (CrCl) should be calculated per institutional standard. International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x upper limit of normal (ULN) unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (specimens must be collected within 72 hours prior to the start of study treatment) Activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (specimens must be collected within 72 hours prior to the start of study treatment) Serum creatinine =< 1.5 x ULN OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 40 mL/min (>= 0.67 mL/sec) for participant with creatinine levels > 1.5 x institutional ULN (specimens must be collected within 72 hours prior to the start of study treatment) Creatinine clearance (CrCl) calculated per the Cockcroft and Gault formula Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (specimens must be collected within 72 hours prior to the start of study treatment) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (=< 5 x ULN for participants with liver metastases) (specimens must be collected within 72 hours prior to the start of study treatment) All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin [beta-hCG]) at the screening visit and the baseline visit. A pregnancy test needs to be performed within 72 hours of the first dose of study drug. Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception for the entire study period and for 120 days after study discontinuation Male subjects who are partners of women of childbearing potential must use a condom and their female partners of childbearing potential must use a highly effective method of contraception beginning at least 1 menstrual cycle prior to starting study drugs, throughout the entire study period, and for 120 days after the last dose of study drug, unless the male subjects are totally sexually abstinent or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile Exclusion Criteria: Evidence of metastatic disease on pre-treatment imaging The subject has received of any type of cytotoxic, biologic or other systemic anticancer therapy for kidney cancer The subject has received any other type of investigational agent within 28 days before the first dose of study treatment Excluding the primary tumor leading to enrollment in this study, any other active malignancy (except for localized prostate cancer, definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the bladder or cervix) within the past 24 months Prior treatment with lenvatinib or any agent directed against PD-1, PD-L1 or PD-L2, or another stimulatory or co inhibitory T-cell receptor (e.g. CTLA-4, OX 40, CD137) Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment Subjects having > 1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Subjects with urine protein >= 1 g/24-hour will be ineligible Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: Cardiovascular disorders: New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months Uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment Prolongation of corrected QT (QTc) interval to > 480 msec per electrocardiogram (ECG) within 28 days before first dose of study treatment Clinically significant hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g. pulmonary hemorrhage) within 3 weeks prior to the first dose of study drug Serious non-healing wound/ulcer/bone fracture History of organ allograft (subject has had an allogenic tissue/solid organ transplant) Biologic response modifiers (e.g. granulocyte colony-stimulating factor) within 4 weeks before study entry. Chronic erythropoietin therapy is permitted provided that no dose adjustments were made within 2 months before first dose of study treatment Subjects must have recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist are live attenuated vaccines and are not allowed Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease Has an active infection requiring systemic therapy Has a known history of active Hepatitis B (e.g., hepatitis B surface antigen [HBsAg]) or hepatitis C (e.g., HCV RNA qualitative is detected) Has uncontrolled HIV defined by a CD4+ count < 350 cells/uL, an AIDS-defining opportunistic infection within the last 12 months prior to study enrollment or documented multidrug resistance that prevents effective HIV therapy Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet A Bilen, MD
Phone
404-778-3693
Email
mehmet.a.bilen@emory.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Viraj Master, MD
Phone
404-778-4898
Email
vmaster@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet A Bilen, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sierra Williams
Phone
404-778-4729
Email
sierra.williams@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results of the trial and not individual patient data will be shared. The study protocol, consent, and investigator's brochure will be available. The statistical plan is incorporated into the protocol, along with inclusion and exclusion criteria.

Learn more about this trial

Perioperative Lenvatinib With Pembrolizumab in Patients With Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma

We'll reach out to this number within 24 hrs