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Combining pazopanib with abexinostat for advanced kidney cancer

A Randomized, Phase 3, Double-blind, Placebo-controlled Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma(RENAVIV)

Phase 3 Interventional Xynomic Pharmaceuticals, Inc. · NCT03592472

This study is testing whether combining two drugs, pazopanib and abexinostat, can help people with advanced kidney cancer live longer without their disease getting worse compared to just taking pazopanib alone.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment413 (estimated)
Ages18 Years and up
SexAll
SponsorXynomic Pharmaceuticals, Inc. Industry-sponsored
Drugs / interventionsradiation
Locations38 sites (Phoenix, Arizona and 37 other locations)
Trial IDNCT03592472 on ClinicalTrials.gov

What this trial studies

This Phase 3, double-blind, placebo-controlled trial investigates the efficacy of pazopanib combined with abexinostat compared to pazopanib with a placebo in patients with locally advanced or metastatic renal cell carcinoma (RCC). Patients will be randomly assigned to one of the two treatment groups and monitored for disease progression using RECIST criteria. If patients in the placebo group experience disease progression, they will have the option to switch to the combination treatment. The study aims to evaluate progression-free survival and overall treatment tolerability.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed clear cell renal cell carcinoma that is locally advanced or metastatic.

Not a fit: Patients who have previously received vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could improve progression-free survival for patients with advanced renal cell carcinoma.

How similar studies have performed: Previous studies have shown promise in combining targeted therapies for renal cell carcinoma, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

To be enrolled in the study, patients will be required to meet all of the following criteria:

* 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.

Exclusion Criteria:

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

* 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.

Where this trial is running

Phoenix, Arizona and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Renal Cell CarcinomaProgression-free survivalAbexinostatPazopanibRECISTCancer therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.