A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)
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
3 other identifiers
interventional
15
2 countries
269
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2019
Longer than P75 for phase_2
269 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2018
CompletedFirst Posted
Study publicly available on registry
July 23, 2018
CompletedStudy Start
First participant enrolled
January 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedResults Posted
Study results publicly available
October 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2026
ExpectedDecember 3, 2025
November 1, 2025
5.7 years
July 19, 2018
September 23, 2025
November 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
The Kaplan-Meier method will be used to estimate 1-year PFS, defined as the time from randomization to disease progression or death due to any cause. The 70% confidence interval was chosen to match the one-sided significance level of alpha = 0.15 specified in the protocol analysis plan.
Up to 1 year from study entry
Secondary Outcomes (3)
Overall Survival (OS)
Up to 1 year from study entry
Overall Response Rate (ORR)
Up to 1 year from study entry
Percentage of Patients Experiencing Adverse Events (AEs)
Up to 2 years from study entry
Other Outcomes (3)
Translocation Morphology Renal Cell Carcinoma Clinical Behavior
Up to 2 years from study entry
Type of Antitumor Immune Response and Stability of T Cell Activation
Up to 1 year from study entry
Pharmacokinetics (PK) Parameters of Axitinib
Up to 12 weeks from study entry
Study Arms (3)
Arm A (axitinib, nivolumab)
EXPERIMENTALPatients 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.
Arm B (axitinib)
EXPERIMENTALPatients 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)
Arm C (nivolumab)
EXPERIMENTALPatients 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.
Interventions
Given PO
Given IV
Eligibility Criteria
You may qualify if:
- 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)
- +24 more criteria
You may not qualify if:
- Patients unable to swallow whole tablets
- Patients who in the opinion of the investigator are not able to comply with the study procedures are not eligible
- Prior Therapy
- Patients who have received prior therapy with axitinib, nivolumab, or other PD1/PD-L1 targeted therapies
- Patients who have received prior therapy with more than one anti VEGF based agent (antibody or tyrosine kinase inhibitor)
- Patients with hypersensitivity to axitinib, nivolumab, or any of its excipients
- Patients who previously received an allogeneic stem cell transplant (SCT) or solid organ transplant are not eligible
- Patients may not be receiving any other investigational agents (within 4 weeks prior to study enrollment)
- Patients who have received prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study enrollment or who have not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks prior to enrollment
- Surgery: Patients who have had or who are planning to have the following invasive procedures are not eligible:
- Major surgical procedure, laparoscopic procedure, open biopsy, core biopsy, fine needle aspirate, or significant traumatic injury within 7 days prior to enrollment. NOTE: External central lines must be placed at least 3 days prior to planned treatment initiation and subcutaneous ports must be placed at least 7 days prior to planned treatment initiation
- Patients who are planning cytoreductive surgery within the first 12 weeks following therapy initiation
- Patients who have a serious or non-healing wound or ulcer at the time of study enrollment are not eligible
- Patients who have a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study enrollment are not eligible
- Patients who have received prior targeted small molecule therapy within 2 weeks of enrollment or have not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks prior to enrollment. NOTE: Subjects with =\< grade 2 neuropathy are an exception to this criterion and may qualify for the study
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (269)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
CTCA at Western Regional Medical Center
Goodyear, Arizona, 85338, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, 71913, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591, United States
Kaiser Permanente-Anaheim
Anaheim, California, 92806, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420, United States
PCR Oncology
Arroyo Grande, California, 93420, United States
Kaiser Permanente-Bellflower
Bellflower, California, 90706, United States
Mercy Cancer Center - Carmichael
Carmichael, California, 95608, United States
Mercy San Juan Medical Center
Carmichael, California, 95608, United States
Kaiser Permanente Downey Medical Center
Downey, California, 90242, United States
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758, United States
Kaiser Permanente-Fontana
Fontana, California, 92335, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Mattel Children's Hospital UCLA
Los Angeles, California, 90095, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Mercy Cancer Center - Rocklin
Rocklin, California, 95765, United States
Mercy Cancer Center - Sacramento
Sacramento, California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Kaiser Permanente-San Diego Mission
San Diego, California, 92108, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, 93401, United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, 93444, United States
Woodland Memorial Hospital
Woodland, California, 95695, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907, United States
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923, United States
AdventHealth Porter
Denver, Colorado, 80210, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218, United States
CommonSpirit Cancer Center Mercy
Durango, Colorado, 81301, United States
Mercy Medical Center
Durango, Colorado, 81301, United States
Mountain Blue Cancer Care Center
Golden, Colorado, 80401, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228, United States
Saint Anthony Hospital
Lakewood, Colorado, 80228, United States
AdventHealth Littleton
Littleton, Colorado, 80122, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, 80501, United States
AdventHealth Parker
Parker, Colorado, 80138, United States
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado, 81008, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, 80260, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
Nemours Children's Hospital
Orlando, Florida, 32827, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607, United States
Saint Mary's Medical Center
West Palm Beach, Florida, 33407, United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503, United States
Greater Regional Medical Center
Creston, Iowa, 50801, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
Flaget Memorial Hospital
Bardstown, Kentucky, 40004, United States
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701, United States
Saint Joseph Hospital
Lexington, Kentucky, 40504, United States
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504, United States
Saint Joseph Hospital East
Lexington, Kentucky, 40509, United States
Saint Joseph London
London, Kentucky, 40741, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
Norton Children's Hospital
Louisville, Kentucky, 40202, United States
Saints Mary and Elizabeth Hospital
Louisville, Kentucky, 40215, United States
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245, United States
Saint Joseph Mount Sterling
Mount Sterling, Kentucky, 40353, United States
Jewish Hospital Medical Center South
Shepherdsville, Kentucky, 40165, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236, United States
Huron Medical Center PC
Port Huron, Michigan, 48060, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337, United States
Cambridge Medical Center
Cambridge, Minnesota, 55008, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Health Partners Inc
Minneapolis, Minnesota, 55454, United States
Monticello Cancer Center
Monticello, Minnesota, 55362, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
Fairview Northland Medical Center
Princeton, Minnesota, 55371, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108, United States
Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, 68803, United States
Fred and Pamela Buffett Cancer Center - Kearney
Kearney, Nebraska, 68845, United States
CHI Health Good Samaritan
Kearney, Nebraska, 68847, United States
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Hematology and Oncology Consultants PC
Omaha, Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Midlands Community Hospital
Papillion, Nebraska, 68046, United States
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703, United States
Cancer and Blood Specialists-Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, 89052, United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074, United States
Las Vegas Urology - Green Valley
Henderson, Nevada, 89074, United States
Oncology Las Vegas - Henderson
Henderson, Nevada, 89074, United States
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074, United States
Desert West Surgery
Las Vegas, Nevada, 89102, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103, United States
Cancer and Blood Specialists-Shadow
Las Vegas, Nevada, 89106, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106, United States
Urology Specialists of Nevada - Central
Las Vegas, Nevada, 89106, United States
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, 89109, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, 89113, United States
Las Vegas Urology - Sunset
Las Vegas, Nevada, 89113, United States
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89113, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119, United States
Cancer Therapy and Integrative Medicine
Las Vegas, Nevada, 89121, United States
Ann M Wierman MD LTD
Las Vegas, Nevada, 89128, United States
Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, 89128, United States
Oncology Las Vegas - Tenaya
Las Vegas, Nevada, 89128, United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128, United States
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144, United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, 89148-2405, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148, United States
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, 89149, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169, United States
University Cancer Center
Las Vegas, Nevada, 89169, United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, 89048, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Saint Mary's Regional Medical Center
Reno, Nevada, 89503, United States
Radiation Oncology Associates
Reno, Nevada, 89509, United States
Cancer Care Specialists - Reno
Reno, Nevada, 89511, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Albany Medical Center
Albany, New York, 12208, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247, United States
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Dayton Children's Hospital
Dayton, Ohio, 45404, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Cancer Treatment Centers of America
Tulsa, Oklahoma, 74133, United States
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Cancer Institute - Laurens
Clinton, South Carolina, 29325, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Memorial Hospital
Chattanooga, Tennessee, 37404, United States
Pulmonary Medicine Center of Chattanooga-Hixson
Hixson, Tennessee, 37343, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203, United States
Memorial GYN Plus
Ooltewah, Tennessee, 37363, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723, United States
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802, United States
El Paso Children's Hospital
El Paso, Texas, 79905, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Children's Hospital of San Antonio
San Antonio, Texas, 78207, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229, United States
University Hospital
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507, United States
Overlake Medical Center
Bellevue, Washington, 98004, United States
Highline Medical Center-Main Campus
Burien, Washington, 98166, United States
Saint Elizabeth Hospital
Enumclaw, Washington, 98022, United States
Saint Francis Hospital
Federal Way, Washington, 98003, United States
Saint Clare Hospital
Lakewood, Washington, 98499, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, 98370, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Saint Michael Cancer Center
Silverdale, Washington, 98383, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204, United States
Franciscan Research Center-Northwest Medical Plaza
Tacoma, Washington, 98405, United States
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405, United States
Northwest Medical Specialties PLLC
Tacoma, Washington, 98405, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
West Virginia University Charleston Division
Charleston, West Virginia, 25304, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221, United States
Saint Vincent Hospital Cancer Center at Marinette
Marinette, Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495, United States
HIMA San Pablo Oncologic Hospital
Caguas, 00726, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Results Reporting Coordinator
- Organization
- Children's Oncology Group
Study Officials
- PRINCIPAL INVESTIGATOR
James I Geller
Children's Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2018
First Posted
July 23, 2018
Study Start
January 8, 2019
Primary Completion
September 30, 2024
Study Completion (Estimated)
November 13, 2026
Last Updated
December 3, 2025
Results First Posted
October 10, 2025
Record last verified: 2025-11