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RENAVIV Study: Pazopanib with or without Abexinostat for Kidney Cancer

This study, called RENAVIV, is testing a combination of two drugs, pazopanib and abexinostat, for people with advanced kidney cancer (renal cell carcinoma). All participants will receive pazopanib. Some will also receive abexinostat, while others will receive a placebo (an inactive substance) instead of abexinostat. Researchers want to see if adding abexinostat helps patients live longer without their cancer getting worse (progression-free survival). You may be able to join if you are 18 or older and have advanced kidney cancer that has spread or cannot be removed by surgery. The study is planned to enroll 413 people, but its current status is unclear.

Study design
This is a randomized, Phase 3, double-blind, placebo-controlled study where 413 participants will be randomly assigned to one of two treatment groups.
What's involved
You would take oral medication daily or on specific days of a 28-day cycle. Treatment continues until your cancer progresses, you experience unacceptable side effects, or other discontinuation criteria are met.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be measured from the date you are randomized until your cancer progresses or you die, for up to approximately 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03592472

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Xynomic Pharmaceuticals, Inc.
~413 participants
Updated 2025-04-13 on ClinicalTrials.gov
What's tested:PazopanibAbexinostatPlacebo

At a glance

Recruiting sites
1 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS)
Measured over From randomization date to date of first documentation of progression OR death (up to approximately 4 years).

Conditions

Renal Cell Carcinoma

Explore related trials

Renal Cell Carcinoma

Where it's being run

38 sites across 16 states
Italy9
South Korea5
Poland4
Spain4
California2
Nebraska2
New York2
China2

Study leadership

  • Pamela Munster, M.D. · STUDY_CHAIR · University of California, San Francisco
  • Rahul Aggarwal, M.D. · STUDY_CHAIR · University of California, San Francisco

Who to contact

Sophia Paspal, Ph.D.
[email protected]
6104055974
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Progression-free survival (PFS)From randomization date to date of first documentation of progression OR death (up to approximately 4 years).

    To compare the PFS between treatment arms. PFS is defined as the time (month) interval between date of randomization and date of radiographic disease progression or death for those without prior evidence of progression, as assessed by blinded Independent Review Committee (IRC) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.