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ACTIVE NOT RECRUITING

NCT03595124

PHASE2

A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Months - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2019-01-08

Completion Date

2026-11-13

Last Updated

2025-12-03

Healthy Volunteers

Conditions

Metastatic Renal Cell Carcinoma Stage III Renal Cell Cancer AJCC v8 Stage IV Renal Cell Cancer AJCC v8 TFE3-Rearranged Renal Cell Carcinoma Unresectable Renal Cell Carcinoma

Interventions

DRUG

Axitinib

Given PO

BIOLOGICAL

Nivolumab

Given IV

Inclusion Criteria: * 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) * 2 to \< 6 years - 0.8 mg/dL (male, female) * 6 to \< 10 years - 1 mg/dL (male, female) * 10 to \< 13 years - 1.2 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 Exclusion Criteria: * 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 * Pre-existing conditions, which may include: * Additional known malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer * Patients with underlying immune deficiency, chronic infections including hepatitis, tuberculosis (TB), or autoimmune disease * Human immunodeficiency virus (HIV)-infected patients with the exception of patients on an effective anti-retroviral therapy with an undetectable viral load within 6 months prior to enrollment * Patients with underlying hematologic issues including congenital bleeding diathesis, known previous gastrointestinal (GI) bleeding requiring intervention within the past 6 months, history of hemoptysis within 42 days prior to study enrollment, active pulmonary emboli, or deep vein thromboses (DVT) that are not stable on anticoagulation regimen * Patients must not have had significant vascular disease (i.e. Moya-Moya, aortic aneurysm requiring surgical repair) * A known history of, or any evidence of active, non-infectious pneumonitis * Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to study enrollment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to study enrollment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability * Any uncontrolled, intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia * Any serious medical or psychiatric illness/condition including substance use disorders likely in the judgment of the investigator(s) to interfere or limit compliance with study requirements/treatment * Patients with 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 * Treatments and/or medications the patient is receiving or has received that would make her/him ineligible, including: * Concomitant (or receipt of) treatment with medications that may affect the metabolism of nivolumab and/or axitinib within 7 days prior to planned first dose of protocol therapy * A live vaccine within 30 days of planned first dose of protocol therapy. NOTE: Inactivated flu vaccines are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed * Pregnancy and breast feeding * Due to risks of fetal and teratogenic adverse events as seen in animal studies, a negative pregnancy test must be obtained in females of childbearing potential, defined as females who are post-menarchal. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Females of childbearing potential that are sexually active must agree to either practice 2 medically accepted highly-effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 5 months after the last dose of study drug * Lactating females are not eligible unless they have agreed not to breastfeed their infants starting with the first dose of study therapy through 5 months after the last dose of study therapy * Male patients of reproductive potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy. Prior history of vasectomy does not replace requirement for contraceptive use * Regulatory requirements * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Locations (269)

Children's Hospital of Alabama

Birmingham, Alabama, United States

CTCA at Western Regional Medical Center

Goodyear, Arizona, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Kaiser Permanente-Anaheim

Anaheim, California, United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

PCR Oncology

Arroyo Grande, California, United States

Kaiser Permanente-Bellflower

Bellflower, California, United States

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Kaiser Permanente Downey Medical Center

Downey, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Kaiser Permanente-Fontana

Fontana, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Mattel Children's Hospital UCLA

Los Angeles, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Children's Hospital of Orange County

Orange, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Kaiser Permanente-San Diego Mission

San Diego, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Woodland Memorial Hospital

Woodland, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

AdventHealth Porter

Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, United States

CommonSpirit Cancer Center Mercy

Durango, Colorado, United States

Mercy Medical Center

Durango, Colorado, United States

Mountain Blue Cancer Care Center

Golden, Colorado, United States

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

AdventHealth Littleton

Littleton, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, United States

AdventHealth Parker

Parker, Colorado, United States

Rocky Mountain Cancer Centers-Parker

Parker, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Rocky Mountain Cancer Centers - Pueblo

Pueblo, Colorado, United States

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Nicklaus Children's Hospital

Miami, Florida, United States

Nemours Children's Hospital

Orlando, Florida, United States

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, United States

Saint Mary's Medical Center

West Palm Beach, Florida, United States

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Northwestern University

Chicago, Illinois, United States

Rush MD Anderson Cancer Center

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Saint Jude Midwest Affiliate

Peoria, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

The Carle Foundation Hospital

Urbana, Illinois, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Alegent Health Mercy Hospital

Council Bluffs, Iowa, United States

Greater Regional Medical Center

Creston, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Mercy Medical Center-West Lakes

West Des Moines, Iowa, United States

Flaget Memorial Hospital

Bardstown, Kentucky, United States

Commonwealth Cancer Center-Corbin

Corbin, Kentucky, United States

Saint Joseph Hospital

Lexington, Kentucky, United States

Saint Joseph Radiation Oncology Resource Center

Lexington, Kentucky, United States

Saint Joseph Hospital East

Lexington, Kentucky, United States

Saint Joseph London

London, Kentucky, United States

Jewish Hospital

Louisville, Kentucky, United States

Norton Children's Hospital

Louisville, Kentucky, United States

Saints Mary and Elizabeth Hospital

Louisville, Kentucky, United States

UofL Health Medical Center Northeast

Louisville, Kentucky, United States

Saint Joseph Mount Sterling

Mount Sterling, Kentucky, United States

Jewish Hospital Medical Center South

Shepherdsville, Kentucky, United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Baystate Medical Center

Springfield, Massachusetts, United States

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

Henry Ford Health Saint John Hospital

Detroit, Michigan, United States

Huron Medical Center PC

Port Huron, Michigan, United States

Lake Huron Medical Center

Port Huron, Michigan, United States

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Cambridge Medical Center

Cambridge, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Unity Hospital

Fridley, Minnesota, United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Health Partners Inc

Minneapolis, Minnesota, United States

Monticello Cancer Center

Monticello, Minnesota, United States

New Ulm Medical Center

New Ulm, Minnesota, United States

Fairview Northland Medical Center

Princeton, Minnesota, United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Lakeview Hospital

Stillwater, Minnesota, United States

Ridgeview Medical Center

Waconia, Minnesota, United States

Rice Memorial Hospital

Willmar, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Fairview Lakes Medical Center

Wyoming, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Cardinal Glennon Children's Medical Center

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Nebraska Cancer Specialists/Oncology Hematology West PC

Grand Island, Nebraska, United States

Fred and Pamela Buffett Cancer Center - Kearney

Kearney, Nebraska, United States

CHI Health Good Samaritan

Kearney, Nebraska, United States

Saint Elizabeth Regional Medical Center

Lincoln, Nebraska, United States

Alegent Health Immanuel Medical Center

Omaha, Nebraska, United States

Hematology and Oncology Consultants PC

Omaha, Nebraska, United States

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, United States

Alegent Health Lakeside Hospital

Omaha, Nebraska, United States

Creighton University Medical Center

Omaha, Nebraska, United States

Midlands Community Hospital

Papillion, Nebraska, United States

Carson Tahoe Regional Medical Center

Carson City, Nevada, United States

Cancer and Blood Specialists-Henderson

Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Horizon Ridge

Henderson, Nevada, United States

Las Vegas Cancer Center-Henderson

Henderson, Nevada, United States

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, United States

Las Vegas Urology - Green Valley

Henderson, Nevada, United States

Oncology Las Vegas - Henderson

Henderson, Nevada, United States

Urology Specialists of Nevada - Green Valley

Henderson, Nevada, United States

Desert West Surgery