A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups

Who is this study for? Patients with unresectable or metastatic TFE/translocation renal cell carcinoma
What treatments are being studied? Axitinib+Nivolumab
Status: Recruiting
Location: See all (263) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II trial studies how well axitinib and nivolumab work in treating patients with TFE/translocation renal cell carcinoma that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving axitinib and nivolumab may work better in treating patients with TFE/translocation renal cell carcinoma compared to standard treatment, including surgery, chemotherapy, or immunotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: No
View:

• Patients must be >= 12 months at enrollment

• Patients must have a body surface area (BSA) >= 0.53 m^2

• Histologically confirmed unresectable or metastatic translocation morphology renal cell carcinoma diagnosed using World Health Organization (WHO)-defined criteria. Patients may be newly diagnosed or have received prior cancer therapy

• Patients must have had histologic verification of the malignancy

• Patients must have measurable disease, documented by clinical, radiographic, or histologic criteria as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1

• Patients must have a tumor showing the appropriate morphologic appearance, and either confirmed TFE3 nuclear protein expression by immunohistochemistry with appropriate positive and negative controls performed at a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, or evidence of TFE3 or TFEb translocation by either fluorescence in situ hybridization (FISH) or reverse transcriptase- polymerase chain reaction (RT-PCR) performed at a CLIA-certified laboratory. For TFE3 immunohistochemistry, any nuclear positivity in the presence of appropriate positive and negative controls should be considered as evidence of TFE3 immunohistochemical expression. NOTE: If the institution is unable to perform these studies, unstained slides may be submitted to Dr. Elizabeth Perlman, who will perform TFE3 analysis at no charge. The slide will be returned to the referring institution for local evaluation, to be included in their institutional report

• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age

• Patients must have a life expectancy of >= 8 weeks

• Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study

• Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (6 weeks if prior nitrosourea)

• Immunotherapy: Must not have received within 4 weeks of entry onto this study

• Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent

• Radiation therapy (RT): >= 2 weeks for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation

• Peripheral absolute neutrophil count (ANC) >= 1000/uL (performed within 7 days prior to enrollment)

• Platelet count >= 75,000/uL (transfusion independent) (performed within 7 days prior to enrollment)

• Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (performed within 7 days prior to enrollment)

• Urine protein: =< 30 mg/dL in urinalysis or =< 1+ on dipstick, unless quantitative protein is < 1000 mg in a 24 hours (h) urine sample (performed within 7 days prior to enrollment)

• For patients < 18 years of age: Serum creatinine =< 1.5 x upper limit of normal (ULN), or measured or calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2 for patient with creatinine levels > 1.5 x institutional ULN, or a serum creatinine based on age/gender as follows (performed within 7 days prior to enrollment):

• 1 to < 2 years - 0.6 mg/dL (male, female)

• 13 to < 16 years - 1.5 mg/dL (male), 1.4 mg/dL (female)

• >= 16 years - 1.7 mg/dL (male), 1.4 mg/dL (female)

• Creatinine clearance should be calculated per institutional standard

• For patients >= 18 years of age: Serum creatinine =< 2 x ULN, or measured or calculated creatinine clearance or radioisotope GFR >= 40 mL/min/1.73 m^2 for patient with creatinine levels > 2 x institutional ULN (performed within 7 days prior to enrollment)

• Creatinine clearance should be calculated per institutional standard

• Serum total bilirubin =< 1.5 x ULN for age, or direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 X ULN (performed within 7 days prior to enrollment)

• Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x ULN for age (performed within 7 days prior to enrollment)

• Albumin > 2.5 mg/dL (performed within 7 days prior to enrollment)

• Shortening fraction of >= 27% by echocardiogram, or

• Ejection fraction of >= 50% by radionuclide angiogram

• No history of myocardial infarction, severe or unstable angina, or peripheral vascular disease

• Corrected QT (QTc) =< 480 msec. Note: Patients with grade 1 prolonged QTc (450-480 msec) at the time of study enrollment should have correctable causes of prolonged QTc addressed if possible (i.e., electrolytes, medications)

• International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN. However, if patient is receiving anticoagulant therapy, PT or partial thromboplastin time (PTT) should be within therapeutic range of intended use of anticoagulants

• Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

• A baseline blood pressure (BP) =< the 95th percentile for age, height, and gender for patients < 18 years old, or =< 150 mmHg (systolic) and =< 90 mmHg (diastolic) for patients >= 18 years old

• Note: 2 serial blood pressures should be taken at least 1 hour apart and averaged to determine baseline BP

• Patients are eligible if on stable doses (>= 7 days) of anti-hypertensive medications with a baseline BP meeting the criteria above

Locations
United States
Alabama
Children's Hospital of Alabama
Recruiting
Birmingham
Arkansas
CHI Saint Vincent Cancer Center Hot Springs
Suspended
Hot Springs
Arkansas Children's Hospital
Recruiting
Little Rock
Arizona
CTCA at Western Regional Medical Center
Recruiting
Goodyear
Cancer Center at Saint Joseph's
Recruiting
Phoenix
California
Kaiser Permanente-Anaheim
Recruiting
Anaheim
Mission Hope Medical Oncology - Arroyo Grande
Recruiting
Arroyo Grande
PCR Oncology
Recruiting
Arroyo Grande
Kaiser Permanente-Bellflower
Recruiting
Bellflower
Kaiser Permanente Downey Medical Center
Recruiting
Downey
Kaiser Permanente-Fontana
Recruiting
Fontana
Kaiser Permanente Los Angeles Medical Center
Recruiting
Los Angeles
Mattel Children's Hospital UCLA
Recruiting
Los Angeles
Kaiser Permanente-Oakland
Recruiting
Oakland
Children's Hospital of Orange County
Recruiting
Orange
University of California Davis Comprehensive Cancer Center
Recruiting
Sacramento
Kaiser Permanente-San Diego Mission
Recruiting
San Diego
Pacific Central Coast Health Center-San Luis Obispo
Recruiting
San Luis Obispo
Mission Hope Medical Oncology - Santa Maria
Recruiting
Santa Maria
Colorado
Children's Hospital Colorado
Suspended
Aurora
University of Colorado Hospital
Recruiting
Aurora
Penrose-Saint Francis Healthcare
Recruiting
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
Recruiting
Colorado Springs
Saint Francis Cancer Center
Recruiting
Colorado Springs
Porter Adventist Hospital
Recruiting
Denver
Presbyterian - Saint Lukes Medical Center - Health One
Active, not recruiting
Denver
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Recruiting
Denver
Mercy Medical Center
Recruiting
Durango
Southwest Oncology PC
Recruiting
Durango
Mountain Blue Cancer Care Center
Suspended
Golden
Rocky Mountain Cancer Centers-Lakewood
Suspended
Lakewood
Saint Anthony Hospital
Recruiting
Lakewood
Littleton Adventist Hospital
Recruiting
Littleton
Longmont United Hospital
Recruiting
Longmont
Rocky Mountain Cancer Centers-Longmont
Suspended
Longmont
Parker Adventist Hospital
Recruiting
Parker
Rocky Mountain Cancer Centers-Parker
Suspended
Parker
Rocky Mountain Cancer Centers - Pueblo
Suspended
Pueblo
Saint Mary Corwin Medical Center
Recruiting
Pueblo
Rocky Mountain Cancer Centers-Thornton
Suspended
Thornton
Connecticut
Connecticut Children's Medical Center
Recruiting
Hartford
Washington, D.c.
Children's National Medical Center
Recruiting
Washington
Delaware
Alfred I duPont Hospital for Children
Recruiting
Wilmington
Florida
Broward Health Medical Center
Recruiting
Fort Lauderdale
Golisano Children's Hospital of Southwest Florida
Recruiting
Fort Myers
University of Florida Health Science Center - Gainesville
Active, not recruiting
Gainesville
Nemours Children's Clinic-Jacksonville
Recruiting
Jacksonville
Nicklaus Children's Hospital
Recruiting
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Not yet recruiting
Miami
Nemours Children's Hospital
Recruiting
Orlando
Saint Joseph's Hospital/Children's Hospital-Tampa
Recruiting
Tampa
Georgia
Children's Healthcare of Atlanta - Egleston
Recruiting
Atlanta
Hawaii
Kapiolani Medical Center for Women and Children
Recruiting
Honolulu
Iowa
Medical Oncology and Hematology Associates-West Des Moines
Recruiting
Clive
Mercy Cancer Center-West Lakes
Recruiting
Clive
Alegent Health Mercy Hospital
Recruiting
Council Bluffs
Greater Regional Medical Center
Recruiting
Creston
Mercy Medical Center - Des Moines
Recruiting
Des Moines
Mission Cancer and Blood - Laurel
Recruiting
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Recruiting
Iowa City
Mercy Medical Center-West Lakes
Recruiting
West Des Moines
Illinois
Northwestern University
Recruiting
Chicago
Rush University Medical Center
Recruiting
Chicago
University of Chicago Comprehensive Cancer Center
Recruiting
Chicago
Carle on Vermilion
Recruiting
Danville
Carle Physician Group-Effingham
Recruiting
Effingham
Northwestern Medicine Lake Forest Hospital
Active, not recruiting
Lake Forest
Carle Physician Group-Mattoon/Charleston
Recruiting
Mattoon
Saint Jude Midwest Affiliate
Recruiting
Peoria
Carle Cancer Center
Recruiting
Urbana
The Carle Foundation Hospital
Recruiting
Urbana
Indiana
Riley Hospital for Children
Recruiting
Indianapolis
Kentucky
Flaget Memorial Hospital
Recruiting
Bardstown
Commonwealth Cancer Center-Corbin
Recruiting
Corbin
Saint Joseph Hospital East
Recruiting
Lexington
Saint Joseph Radiation Oncology Resource Center
Recruiting
Lexington
University of Kentucky/Markey Cancer Center
Recruiting
Lexington
Saint Joseph London
Recruiting
London
Jewish Hospital
Suspended
Louisville
Norton Children's Hospital
Recruiting
Louisville
Saints Mary and Elizabeth Hospital
Suspended
Louisville
UofL Health Medical Center Northeast
Suspended
Louisville
Jewish Hospital Medical Center South
Suspended
Shepherdsville
Louisiana
Ochsner Medical Center Jefferson
Recruiting
New Orleans
Massachusetts
Dana-Farber Cancer Institute
Recruiting
Boston
Baystate Medical Center
Recruiting
Springfield
Maryland
Sinai Hospital of Baltimore
Recruiting
Baltimore
Michigan
C S Mott Children's Hospital
Recruiting
Ann Arbor
Ascension Saint John Hospital
Active, not recruiting
Detroit
Huron Medical Center PC
Suspended
Port Huron
Lake Huron Medical Center
Suspended
Port Huron
Minnesota
Fairview Ridges Hospital
Recruiting
Burnsville
Minnesota Oncology - Burnsville
Recruiting
Burnsville
Cambridge Medical Center
Recruiting
Cambridge
Mercy Hospital
Recruiting
Coon Rapids
Fairview Southdale Hospital
Recruiting
Edina
Unity Hospital
Recruiting
Fridley
Fairview Clinics and Surgery Center Maple Grove
Recruiting
Maple Grove
Minnesota Oncology Hematology PA-Maplewood
Recruiting
Maplewood
Saint John's Hospital - Healtheast
Recruiting
Maplewood
Abbott-Northwestern Hospital
Recruiting
Minneapolis
Children's Hospitals and Clinics of Minnesota - Minneapolis
Recruiting
Minneapolis
Health Partners Inc
Recruiting
Minneapolis
Hennepin County Medical Center
Recruiting
Minneapolis
Monticello Cancer Center
Recruiting
Monticello
New Ulm Medical Center
Recruiting
New Ulm
Fairview Northland Medical Center
Recruiting
Princeton
North Memorial Medical Health Center
Recruiting
Robbinsdale
Park Nicollet Clinic - Saint Louis Park
Recruiting
Saint Louis Park
Regions Hospital
Recruiting
Saint Paul
United Hospital
Recruiting
Saint Paul
Saint Francis Regional Medical Center
Recruiting
Shakopee
Lakeview Hospital
Recruiting
Stillwater
Ridgeview Medical Center
Recruiting
Waconia
Rice Memorial Hospital
Recruiting
Willmar
Minnesota Oncology Hematology PA-Woodbury
Recruiting
Woodbury
Fairview Lakes Medical Center
Recruiting
Wyoming
Missouri
Children's Mercy Hospitals and Clinics
Recruiting
Kansas City
Cardinal Glennon Children's Medical Center
Recruiting
Saint Louis
Mercy Hospital Saint Louis
Recruiting
Saint Louis
Washington University School of Medicine
Recruiting
Saint Louis
Mississippi
University of Mississippi Medical Center
Recruiting
Jackson
North Carolina
Mission Hospital
Recruiting
Asheville
UNC Lineberger Comprehensive Cancer Center
Active, not recruiting
Chapel Hill
Carolinas Medical Center/Levine Cancer Institute
Recruiting
Charlotte
Nebraska
CHI Health Saint Francis
Suspended
Grand Island
CHI Health Good Samaritan
Recruiting
Kearney
Heartland Hematology and Oncology
Suspended
Kearney
Saint Elizabeth Regional Medical Center
Recruiting
Lincoln
Alegent Health Bergan Mercy Medical Center
Recruiting
Omaha
Alegent Health Immanuel Medical Center
Recruiting
Omaha
Alegent Health Lakeside Hospital
Recruiting
Omaha
Creighton University Medical Center
Recruiting
Omaha
Hematology and Oncology Consultants PC
Suspended
Omaha
Midlands Community Hospital
Recruiting
Papillion
New Jersey
Hackensack University Medical Center
Recruiting
Hackensack
Nevada
Carson Tahoe Regional Medical Center
Recruiting
Carson City
Cancer and Blood Specialists-Henderson
Suspended
Henderson
Comprehensive Cancer Centers of Nevada - Henderson
Recruiting
Henderson
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Recruiting
Henderson
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Recruiting
Henderson
GenesisCare USA - Henderson
Recruiting
Henderson
Las Vegas Cancer Center-Henderson
Recruiting
Henderson
Las Vegas Urology - Green Valley
Recruiting
Henderson
OptumCare Cancer Care at Seven Hills
Recruiting
Henderson
Urology Specialists of Nevada - Green Valley
Recruiting
Henderson
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Recruiting
Las Vegas
Ann M Wierman MD LTD
Recruiting
Las Vegas
Cancer and Blood Specialists-Shadow
Suspended
Las Vegas
Cancer and Blood Specialists-Tenaya
Suspended
Las Vegas
Cancer Therapy and Integrative Medicine
Suspended
Las Vegas
Comprehensive Cancer Centers of Nevada
Recruiting
Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
Recruiting
Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest
Recruiting
Las Vegas
Comprehensive Cancer Centers of Nevada - Town Center
Recruiting
Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin
Recruiting
Las Vegas
Desert West Surgery
Suspended
Las Vegas
GenesisCare USA - Fort Apache
Recruiting
Las Vegas
GenesisCare USA - Las Vegas
Recruiting
Las Vegas
GenesisCare USA - Vegas Tenaya
Recruiting
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Suspended
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Suspended
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Suspended
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Suspended
Las Vegas
Hope Cancer Care of Nevada
Recruiting
Las Vegas
Las Vegas Cancer Center-Medical Center
Recruiting
Las Vegas
Las Vegas Urology - Sunset
Recruiting
Las Vegas
OptumCare Cancer Care at Charleston
Recruiting
Las Vegas
OptumCare Cancer Care at Fort Apache
Recruiting
Las Vegas
OptumCare Cancer Care at MountainView
Recruiting
Las Vegas
Radiation Oncology Centers of Nevada Central
Recruiting
Las Vegas
Radiation Oncology Centers of Nevada Southeast
Recruiting
Las Vegas
Summerlin Hospital Medical Center
Recruiting
Las Vegas
Sunrise Hospital and Medical Center
Recruiting
Las Vegas
University Cancer Center
Suspended
Las Vegas
University Medical Center of Southern Nevada
Recruiting
Las Vegas
Urology Specialists of Nevada - Central
Recruiting
Las Vegas
Urology Specialists of Nevada - Northwest
Recruiting
Las Vegas
Urology Specialists of Nevada - Southwest
Recruiting
Las Vegas
Hope Cancer Care of Nevada-Pahrump
Recruiting
Pahrump
Cancer Care Specialists - Reno
Suspended
Reno
Radiation Oncology Associates
Recruiting
Reno
Renown Regional Medical Center
Recruiting
Reno
Saint Mary's Regional Medical Center
Recruiting
Reno
New York
Albany Medical Center
Recruiting
Albany
Montefiore Medical Center - Moses Campus
Recruiting
Bronx
Maimonides Medical Center
Recruiting
Brooklyn
The Steven and Alexandra Cohen Children's Medical Center of New York
Recruiting
New Hyde Park
Memorial Sloan Kettering Cancer Center
Recruiting
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Recruiting
New York
State University of New York Upstate Medical University
Recruiting
Syracuse
Ohio
Children's Hospital Medical Center of Akron
Recruiting
Akron
Bethesda North Hospital
Recruiting
Cincinnati
Cincinnati Children's Hospital Medical Center
Recruiting
Cincinnati
Good Samaritan Hospital - Cincinnati
Recruiting
Cincinnati
TriHealth Cancer Institute-Anderson
Recruiting
Cincinnati
TriHealth Cancer Institute-Westside
Recruiting
Cincinnati
Case Western Reserve University
Recruiting
Cleveland
Cleveland Clinic Foundation
Recruiting
Cleveland
Rainbow Babies and Childrens Hospital
Recruiting
Cleveland
Nationwide Children's Hospital
Recruiting
Columbus
Dayton Children's Hospital
Recruiting
Dayton
ProMedica Flower Hospital
Recruiting
Sylvania
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Recruiting
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
Recruiting
Oklahoma City
Cancer Treatment Centers of America
Active, not recruiting
Tulsa
Oregon
Legacy Emanuel Children's Hospital
Recruiting
Portland
Oregon Health and Science University
Recruiting
Portland
Pennsylvania
Children's Hospital of Philadelphia
Recruiting
Philadelphia
Fox Chase Cancer Center
Active, not recruiting
Philadelphia
Children's Hospital of Pittsburgh of UPMC
Recruiting
Pittsburgh
South Carolina
Prisma Health Cancer Institute - Spartanburg
Recruiting
Boiling Springs
Medical University of South Carolina
Recruiting
Charleston
Prisma Health Cancer Institute - Laurens
Suspended
Clinton
Prisma Health Cancer Institute - Easley
Recruiting
Easley
Prisma Health Cancer Institute - Butternut
Recruiting
Greenville
Prisma Health Cancer Institute - Eastside
Recruiting
Greenville
Prisma Health Cancer Institute - Faris
Recruiting
Greenville
Prisma Health Cancer Institute - Greer
Recruiting
Greer
Prisma Health Cancer Institute - Seneca
Recruiting
Seneca
Tennessee
Memorial Hospital
Suspended
Chattanooga
Pulmonary Medicine Center of Chattanooga-Hixson
Suspended
Hixson
East Tennessee Childrens Hospital
Recruiting
Knoxville
Saint Jude Children's Research Hospital
Recruiting
Memphis
The Children's Hospital at TriStar Centennial
Recruiting
Nashville
Memorial GYN Plus
Suspended
Ooltewah
Texas
Dell Children's Medical Center of Central Texas
Recruiting
Austin
Saint Joseph Regional Cancer Center
Suspended
Bryan
El Paso Children's Hospital
Recruiting
El Paso
Cook Children's Medical Center
Recruiting
Fort Worth
M D Anderson Cancer Center
Recruiting
Houston
Children's Hospital of San Antonio
Recruiting
San Antonio
Methodist Children's Hospital of South Texas
Recruiting
San Antonio
University Hospital
Active, not recruiting
San Antonio
University of Texas Health Science Center at San Antonio
Recruiting
San Antonio
Utah
Primary Children's Hospital
Recruiting
Salt Lake City
Virginia
University of Virginia Cancer Center
Recruiting
Charlottesville
Children's Hospital of The King's Daughters
Recruiting
Norfolk
Washington
Overlake Medical Center
Recruiting
Bellevue
Harrison HealthPartners Hematology and Oncology-Bremerton
Suspended
Bremerton
Harrison Medical Center
Recruiting
Bremerton
Highline Medical Center-Main Campus
Recruiting
Burien
Saint Elizabeth Hospital
Recruiting
Enumclaw
Saint Francis Hospital
Recruiting
Federal Way
Saint Clare Hospital
Recruiting
Lakewood
Harrison HealthPartners Hematology and Oncology-Poulsbo
Active, not recruiting
Poulsbo
Seattle Children's Hospital
Recruiting
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
Recruiting
Spokane
Franciscan Research Center-Northwest Medical Plaza
Recruiting
Tacoma
Mary Bridge Children's Hospital and Health Center
Recruiting
Tacoma
Northwest Medical Specialties PLLC
Suspended
Tacoma
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Recruiting
Yakima
Wisconsin
Saint Vincent Hospital Cancer Center at Saint Mary's
Recruiting
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Recruiting
Green Bay
Holy Family Memorial Hospital
Suspended
Manitowoc
Saint Vincent Hospital Cancer Center at Marinette
Suspended
Marinette
Marshfield Medical Center-Marshfield
Recruiting
Marshfield
Children's Hospital of Wisconsin
Recruiting
Milwaukee
Cancer Center of Western Wisconsin
Recruiting
New Richmond
Saint Vincent Hospital Cancer Center at Oconto Falls
Recruiting
Oconto Falls
HSHS Saint Nicholas Hospital
Recruiting
Sheboygan
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Recruiting
Sturgeon Bay
West Virginia
West Virginia University Charleston Division
Recruiting
Charleston
Time Frame
Start Date: October 9, 2018
Estimated Completion Date: June 30, 2031
Participants
Target number of participants: 40
Treatments
Experimental: Arm A (axitinib, nivolumab)
Patients receive axitinib PO BID on days 1-28 and nivolumab intravenously (IV) over 30 minutes, or per institutional guidelines, on days 1 and 15 (if < 18 years old) or on day 1 (if >= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
Experimental: Arm B (axitinib)
Patients receive axitinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AS OF 1/23/2020 - PROSPECTIVE PATIENTS ARE RANDOMLY ASSIGNED TO ARMS A OR C)
Experimental: Arm C (nivolumab)
Patients receive nivolumab IV over 30 minutes, or per institutional guidelines, on days 1 and 15 (if < 18 years old) or on day 1 (if >= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
Authors
Lisa L. Hartman, Julie I. Krystal, Kelly L. Vallance, Elyssa M. Rubin, Haydar A. Frangoul, Frederick S. Huang, Ashley E. Meyer, Marcio H. Malogolowkin, Douglas S. Hawkins, Vinod K. Gidvani-Diaz, Julio C. Barredo, Vlad C. Radulescu, Matthew A. Kutny, Eric J. Lowe, Mariko Sato, Ashok B. Raj, Sagun Shrestha, Keith J. August, Lisa Gennarini, Michael S. Isakoff, John J. Letterio, Justine M. Kahn, Ziad A. Khatib, Mukund G. Dole, Elaine T. Lam, David L. Becton, Phillip E. Barnette, Matthew Dietz, Rabi Hanna, Timothy C. Griffin, Katrina Winsnes, Robin D. Hanson, Ranjan Bista, Jennifer A. Domm, Alan Tan, Don E. Eslin, William B. Slayton, Mark J. Mogul, Aron Flagg, Catherine A. Long, Mark A. Ranalli, Priyank P. Patel, David S. Dickens, Pooja Hingorani, William C. Petersen, Matthew R. Zibelman, Erin Wright, Jamie M. Aye, Ray C. Pais, Jamie L. Dargart, Adonis N. Lorenzana, Duncan S. Stearns, Jose M. Esquilin, Aarati V. Rao, Linda C. Stork, Michelle A. Manalang, Vishangi Dave, Aniket Saha, Noah C. Federman, Elizabeth A. Mullen, Sandeep Batra, Thomas A. Olson, James T. Badgett, Robert G. Irwin, Susan E. Spiller, Douglas J. Scothorn, Ami V. Desai, Joanna G. Luty, Robert J. Vasquez, Judy L. Felgenhauer, Sara E. Helmig, Wade T. Kyono, Laura Sedig, Mahmut Y. Celiker, William S. Ferguson, Robert M. Cooper, Nichole L. Bryant, Laura A. Campbell, Philip M. Monteleone, Joel A. Kaplan, Katharine Offer, Alan K. Ikeda, Enrique A. Escalon, Dana A. Obzut, Janice F. Olson, Michael K. Richards, Steven J. Kuerbitz, Meghen B. Browning, Andrew Bukowinski, James I. Geller, Alice Lee, Lauren R. Weintraub, Jason M. Fixler, Jennifer J. Clark, Frank M. Balis, Jeffrey S. Dome, Mohamad H. Badawi, Richard L. Deming, David M. King, Emad K. Salman, Stuart H. Gold, Amy C. Fowler, Robert Galamaga, Michael V. Ortiz, Amy Armstrong, Ayman A. El-Sheikh, Anne-Marie R. Langevin, Pedro A. De Alarcon, Shannon M. Cohn, Najat C. Daw, Jacqueline M. Kraveka, David VanderWeele, Rene Y. McNall-Knapp, Jaime M. Libes, Hector M. Rodriguez-Cortes, Amber M. D'Souza, Jenna M. Sopfe, Ramamoorthy Nagasubramanian, Sarah E. Leary, Anderson (Andy) B. Collier, Brandon D. Bernard
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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