A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)

Inclusion Criteria: To be enrolled in the study, patients will be required to meet all of the followingcriteria:

• 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 locallyadvanced/metastatic setting. Up to 1 line of prior cytokine or immune checkpointinhibitor treatment is allowed in either the (neo)adjuvant or metastatic settingprovided screening scans indicate progressive disease (PD) during or followingcompletion 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 radiationprior to date of randomization.

Exclusion Criteria: Patients who meet any of the following criteria at Screening will not be enrolled in thestudy:

• Has persistent clinically significant toxicities (Grade ≥ 2; per NCI CTCAE version 5from previous anticancer therapy (excluding alopecia which is permitted and excludingGrades 2 and 3 laboratory abnormalities if they are not associated with symptoms, arenot considered clinically significant by the investigator, and can be managed withavailable medical therapies).
• Has untreated central nervous system (CNS) metastases. Patients with treated CNSmetastases are eligible provided imaging demonstrates no new or progressive metastasesobtained at least 4 weeks following completion of treatment. CNS imaging duringScreening is not required unless clinically indicated.
• Has an additional malignancy requiring treatment within the past 3 years. Patientswith the following concomitant neoplastic diagnoses are eligible: non-melanoma skincancer, carcinoma in situ, and non-muscle invasive urothelial carcinoma.
• Poorly controlled hypertension, defined as systolic blood pressure ≥ 160 or diastolicblood pressure ≥ 100 mmHg. Use of anti-hypertensives and rescreening is permitted.
• A new pulmonary embolism or deep venous thrombosis diagnosed within 3 months prior torandomization.
• 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.