NCT03562507

Multi-center Trial of ESK981 in Combination With Nivolumab in Patients With Metastatic Renal Cell Carcinoma

ERICA: Phase 2 Multi-center Trial of ESK981 in Combination With Nivolumab in Patients With Metastatic Renal Cell Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the trial is to determine the clinical efficacy of ESK981 in combination with nivolumab therapy in patients with metastatic renal cell carcinoma (RCC).

Detailed description

The study was terminated early due to changes in the RCC treatment landscape which limited the patient population. Due to this early termination no subjects were enrolled into Cohort B.

Conditions

• Renal Cell Carcinoma, Metastatic

Interventions

Type	Name	Description
DRUG	ESK981	ESK981: 160 mg (4 capsules) PO daily for 5 consecutive days followed by a 2-day off drug in each week, repeated weekly in 4-week (28-day) cycles
DRUG	Nivolumab	480 mg/dose IV, Day 1 of each 28-day cycle

Timeline

• Start date: 2019-04-11
• Primary completion: 2022-10-18
• Completion: 2022-10-18
• First posted: 2018-06-19
• Last updated: 2024-05-20
• Results posted: 2024-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study