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

NCT03502681 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-07-01

Study results available
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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.

Conditions

  • Metastatic Urothelial Cell Cancer

Interventions

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)

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Eisai Inc.

    collaborator INDUSTRY

  • Big Ten Cancer Research Consortium

    collaborator OTHER

  • Monika Joshi, MD

    lead OTHER

Principal Investigators

  • Monika Joshi, M.D. · Big Ten Cancer Research Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-12
Primary Completion
2019-10-25
Completion
2019-10-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03502681 on ClinicalTrials.gov