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

Phase 1 Terminated 6 enrolled Monika Joshi, MD Big Ten Cancer Research Consortium · collab Eisai Inc. · collab Pfizer · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2018-06-12
Primary completion: 2019-10-25
Completion: 2019-10-25

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

Stopped (Business): “Funder Decision”

paper Owing to the early termination, MTD could not be determined. PMID 33741296 ↗

Publications

Joshi M, Holder SL, Zhu J, Zheng H, Komanduri S, Warrick J, Yasin H, Garje R, Jia B, Drabick JJ, DeGraff DJ, Zakharia Y. Avelumab in Combination with Eribulin Mesylate in Metastatic Urothelial Carcinoma: BTCRC GU-051, a Phase 1b Study. Eur Urol Focus. 2022 Mar;8(2):483-490. doi: 10.1016/j.euf.2021.03.005. Epub 2021 Mar 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avelumab	Monoclonal antibody	10 mg/kg	—
Subject	Eribulin	Small molecule	0.7 mg/m2	—
Subject	Eribulin	Small molecule	1.1 mg/m2	—
Subject	Eribulin	Small molecule	1.4 mg/m2	—