NCT03200587

Cabometyx and Avelumab in Patients With Metastatic Renal Cell Carcinoma (mRCC)

A Phase 1B, Open Label, Dose-finding Study to Evaluate the Safety and Tolerability of Cabometyx and Avelumab in Patients With Metastatic Renal Cell Carcinoma (mRCC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, non-controlled, non-randomized, phase I dose-finding, of Cabometyx + Avelumab, to establish safety, feasibility, and the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D) of Cabometyx in combination with Avelumab, and to investigate preliminary efficacy. The MTD or RP2D determined in this study will be used for a future study to formally test efficacy. The MTD determined by dose escalation will be the recommended Phase 2 dose.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Avelumab	Avelumab 10 mg/kg infusion every 2 weeks (Days 1 and 15) of every 28 day cycle for up to 12 cycles
DRUG	Cabozantinib	Cabozantinib oral daily at 20 (starting dose 1), 40 (Dose Level 2) or 60 mg (Dose Level 3)

Timeline

• Start date: 2018-06-21
• Primary completion: 2020-04-14
• Completion: 2021-11-25
• First posted: 2017-06-27
• Last updated: 2024-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study