Trial of an Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma

Metastatic Renal Cell Carcinoma Clinical Trial

Official title: GU-187: Phase II Trial of an Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma

Status Recruiting

Clinical Trial Summary

This is a multi-site, single arm phase II trial of cabozantinib for IMDC all-risk frontline metastatic renal cell carcinoma (mRCC) patients OR any line mRCC patients who have not previously been treated with cabozantinib.

Clinical Trial Description

This is a multi-site, two cohort phase II trial of cabozantinib for IMDC all-risk frontline metastatic renal cell carcinoma (mRCC) patients OR any line mRCC patients who have not previously been treated with cabozantinib. The study is comprised of two cohorts; Cohort A will employ the alternative dosing schema with cabozantinib monotherapy in any-line clear cell or non-clear cell mRCC patients, and Cohort B will employ the alternative dosing schema with cabozantinib in combination with standard-dosed nivolumab in front-line clear cell or non-clear cell mRCC patients.

Study will accrue a total of 86 patients (Cohort A n=49, Cohort B n=37). Patients in both cohorts with be treated with the same cabozantinib alternative dosing schema and schedule, with the exception of Cohort B patients also receiving monthly fix-dosed nivolumab infusions. Patients will start at 40 mg of cabozantinib daily and dose escalate or de-escalate based on pre-specified criteria and at set dosing schedules to allow for smaller median dose changes between adjustments. The de-escalation would be fine-tuned and adjustments would be made in 10 mg average daily dosing increments by utilizing alternate day dosing schedules (e.g. 60 mg/40 mg every other day) rather than decreasing by 20 mg (table 1). The maximum dose of cabozantinib is 60 mg daily, while the lowest dosing level on trial will be 20 mg every other day. Cycles would be 28 days, with weekly follow-up for cycle 1 and bi-weekly follow-up for cycle 2 to allow for prompt dose adjustments, and then monthly. At each check-in, patients that have met the established protocol criteria (outlined in Section 6.3) and were not yet at the maximum dose of 60 mg daily would be eligible for dose-escalation. Patients would also be dose de-escalated as determined by the investigator. Patients who de-escalate may be allowed to re-escalate in the future. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear-cell Metastatic Renal Cell Carcinoma
• Metastatic Renal Cell Carcinoma

• NCT number: NCT05263050
• Study type: Interventional
• Source: Fox Chase Cancer Center
• Contact: Ryan Romasko, MBA
• Phone: 215-728-4097
• Email: ryan.romasko@fccc.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: January 21, 2022
• Completion date: February 2027