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

Running, not enrolling · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT03595124

Run by

National Cancer Institute (NCI)

People needed

15

Starts

2019-01-08

Expected to finish

2026-11-13

Last updated by the study team

2026-07-02

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

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)
• 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

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
• 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

Where it is running

• 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 of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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