Physician

Gary Lu, MD, PhD

 

Study Coordinator

Megan Gavinski, BS
484-503-4157

Megan.Gavinski@sluhn.org

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Treatment Agent: NKTR-214

Synopsis: In this informed consent form, NKTR 214, nivolumab, sunitinib, and cabozantinib are also referred to as study treatment(s). NKTR-214 is being tested to treat RCC, but as it is an investigational drug it is yet to be approved by a regulatory authority for treating this disease. The other study drugs have already been tested and approved for treating RCC.

In this study, you will be required to provide blood and tissue samples in order to further understand how the study treatments behave in your body and how well the study drugs work.

This is an open-label study, which means that both you and your study doctor will know which treatment you will receive. If you meet eligibility criteria and are enrolled into this study, you will be assigned at random (by chance alone, like flipping a coin) to one of the following treatment options. There is a 50% chance that you will receive NKTR-214 and nivolumab in combination and there is a 50% chance that you will receive either sunitinib or cabozantinib.

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• Provide written, informed consent to participate in the study and follow the study procedures
• Karnofsky Performance Status (KPS) of at least 70
• Measurable disease per RECIST 1.1 criteria
• Histological confirmation of advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with clear cell component including patients who may have sarcomatoid features
• At least one International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic factors must be present to qualify as either intermediate or poor risk renal cell carcinoma
• No prior systemic therapy (including neoadjuvant, adjuvant, or vaccine therapy) for RCC
• Patients with stable brain metastases may be enrolled if certain criteria are met
• Archival tumor tissue available

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• Patients who have an active, known or suspected autoimmune disease
• Patients who have a known additional malignancy that is progressing or requires active treatment
• Any tumor invading the superior vena cava (SVC) or other major blood vessels
• Any tumor invading the gastrointestinal (GI) tract or any evidence of endotracheal or endobronchial tumor within 30 days prior to randomization

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Physician

Yacoub Faroun, MD

 

Study Coordinator

Megan Gavinski, BS
484-503-4157

Megan.Gavinski@sluhn.org

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Treatment Agent: Abexinostat

Synopsis: The purpose of this study is to compare the safety and effectiveness of pazopanib plus abexinostat to that of pazopanib plus placebo. This will be accomplished by monitoring how your disease is progressing. To do this, the study doctor and staff will assess how the disease affects your ability to complete daily living activities, test your blood for levels of thyroid hormone and liver enzymes; review results from scans of your tumor(s) and electrocardiogram (ECG) tests (painless, non-invasive tests that show how your heart works); and monitor your general health and vital signs. There will also be a test to find out how much of the medication is in your blood.

Abexinostat has been used in 16 other experimental studies that the Sponsor has conducted. Altogether, 487 people have been exposed either to abexinostat alone or to abexinostat combined with other treatments. One completed study used the same drugs that will be used in this study: abexinostat and pazopanib. The study was done in patients with renal cell carcinoma and it was found that the drugs were tolerated well.

This is a study to find out whether the investigational new drug, abexinostat, will improve the effects of pazopanib (the approved drug) in treating renal cell carcinoma. Because we do not know if abexinostat will improve the effects of pazopanib in treating renal cell carcinoma, we need to compare pazopanib plus abexinostat and pazopanib plus placebo. Participants with renal cell carcinoma who agree to be in this study will take pazopanib and either tablets containing abexinostat or placebo. A placebo is a tablet that does not contain active study medication(s).

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• Patients aged ≥ 18 years at time of study entry.
• Patients have histologically confirmed RCC with clear cell component.
• Patients have locally advanced and unresectable or metastatic disease.
• Measurable disease as assessed only by the investigator (not verified by IRC) according to RECIST version 1.1.
• Patients must not have had any prior vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor treatment in either (neo)adjuvant or locally advanced/metastatic setting. Up to 1 line of prior cytokine or immune checkpoint inhibitor treatment is allowed in either the (neo)adjuvant or metastatic setting provided screening scans indicate progressive disease (PD) during or following completion of treatment.
• Patients have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients have adequate baseline organ function.
• Patients have adequate baseline hematologic function
• Patient must be at least 2 weeks from last systemic treatment or dose of radiation prior to date of randomization.

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• Has persistent clinically significant toxicities (Grade ≥ 2; per NCI CTCAE version 5 from previous anticancer therapy (excluding alopecia which is permitted and excluding Grades 2 and 3 laboratory abnormalities if they are not associated with symptoms, are not considered clinically significant by the investigator, and can be managed with available medical therapies).
• Has untreated central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided imaging demonstrates no new or progressive metastases obtained at least 4 weeks following completion of treatment. CNS imaging during Screening is not required unless clinically indicated.
• Has an additional malignancy requiring treatment within the past 3 years. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ, and non-muscle invasive urothelial carcinoma.
• Poorly controlled hypertension, defined as systolic blood pressure ≥ 160 or diastolic blood pressure ≥ 100 mmHg. Use of anti-hypertensives and rescreening is permitted.
• A new pulmonary embolism or deep venous thrombosis diagnosed within 3 months prior to randomization.
• Has a QTcF interval > 480 msec.
• New York Heart Association Class III or IV congestive heart failure.
• Use of prohibited medication within 7 days or 5 half-lives, whichever is shorter, prior to first dose of study drug.

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