NCT03502681

A Study Combining Eribulin Mesylate With Avelumab in Cisplatin Ineligible Metastatic Urothelial Cell Cancer Patients

Phase 1b Clinical Trial of Eribulin Mesylate and the PD-L1 Monoclonal Antibody, Avelumab, in Cisplatin Ineligible Metastatic Urothelial Cell Cancer Patients

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Monika Joshi, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open-label phase Ib study of combining eribulin mesylate with avelumab. The initial 9-12 patients (MTD cohort) will be enrolled to determine safety of avelumab in combination with eribulin mesylate. Upon determination of maximum tolerated dose (MTD), 12 additional patients will be enrolled in an expansion cohort (efficacy cohort) to determine ORR at 6 months.

Detailed description

Dose Escalation Plan: A standard "3+3" design will be used to determine the MTD of eribulin with avelumab. The maximum tolerated dose is the dose of eribulin combined with avelumab with dose limiting toxicity of 0-1 of 6 patients in the first cycle of combination therapy. After the MTD has been determined, an additional 12 patients will be enrolled in an expansion cohort at the MTD to evaluate the efficacy of this combination. After determination of MTD for eribulin mesylate, an additional 12 patients will be enrolled on the expansion cohort. Subjects on the expansion cohort will be assessed for adverse events but will not be assessed for DLTs.

Conditions

• Metastatic Urothelial Cell Cancer

Interventions

Type	Name	Description
DRUG	Eribulin Mesylate	Days 1, 15 Eribulin mesylate: Dose level -1: 0.7mg/m\^2; Dose level 0: 1.1 mg/m\^2; Dose level +1: 1.4 mg/m\^2
DRUG	Avelumab	Days 1, 15 Avelumab (10mg/kg)

Timeline

• Start date: 2018-06-12
• Primary completion: 2019-10-25
• Completion: 2019-10-25
• First posted: 2018-04-19
• Last updated: 2022-07-01
• Results posted: 2020-07-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study