Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AVEO Pharmaceuticals, Inc.
• Collaborators: Bristol-Myers Squibb; Parexel
• Treatments: Nivolumab

Criteria

Inclusion Criteria:

• Radiographic disease progression during or following at least 6 weeks of treatment with ICI for locally advanced or metastatic RCC with a clear cell component either in first- or second-line treatment.

• Subjects must have recovered from the adverse events of prior therapy or returned to baseline.

• Histologically or cytologically confirmed RCC with a clear cell component.

• Measurable disease per RECIST criteria Version 1.1.

• Eastern Cooperative Oncology Group performance status of 0 or 1.

Exclusion Criteria:

• More than 2 prior lines of therapy in the advanced or metastatic setting.

• History of life-threatening toxicity related to prior immune therapy.

• Active, known, or suspected autoimmune disease.

• Uncontrolled hypertension.

• More than 1 prior line of therapy with a checkpoint inhibitor in the metastatic setting.