A Study Combining Eribulin Mesylate With Avelumab in Cisplatin Ineligible Metastatic Urothelial Cell Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03502681|
Recruitment Status : Recruiting
First Posted : April 19, 2018
Last Update Posted : February 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Urothelial Cell Cancer||Drug: Eribulin Mesylate Drug: Avelumab||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1b Clinical Trial of Eribulin Mesylate and the PD-L1 Monoclonal Antibody, Avelumab, in Cisplatin Ineligible Metastatic Urothelial Cell Cancer Patients|
|Actual Study Start Date :||June 12, 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||July 2019|
Experimental: Maximum tolerated dose (MTD) cohort
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 objective response rate (ORR) at 6 months.
Drug: Eribulin Mesylate
Days 1, 15
Dose level -1: 0.7mg/m^2;
Dose level 0: 1.1 mg/m^2;
Dose level +1: 1.4 mg/m^2
Other Name: Halaven
Days 1, 15 Avelumab (10mg/kg)
- Assess the Adverse Events of Combining Eribulin mesylate with Avelumab - (MTD cohort) [ Time Frame: 4-weeks ]Dose limiting toxicities (DLTs) during the combined eribulin+avelumab
- Assess Response Rates (RR) - (Efficacy cohort) [ Time Frame: 12 months ]Complete Response (CR) + Partial Response (PR)
- Assess Disease Control Rate (DCR) [ Time Frame: at 3, 6 months ]Complete Response (CR) + Partial Response (PR) + Stable Disease (SD)
- Estimate Progression Free Survival (PFS) [ Time Frame: 12 months ]probability that a patient remains free of progression of disease by modified RECIST 1.1
- Estimate Overall Survival (OS) [ Time Frame: 12 months ]time from start of treatment, Day 1, to the date of death due to any cause
- Estimate median Progression Free Survival (PFS) [ Time Frame: 12 months ]measurement from the date of initiation of avelumab+ eribulin, D1 until the criteria for disease progression is met as defined by modified RECIST 1.1
- Estimate median Overall Survival (OS) [ Time Frame: 2.5 years ]time from start of treatment, Day 1, that half of the patients in the group with the disease are still alive.
- Assess the Duration of Response [ Time Frame: 2.5 years ]the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502681
|Contact: Dana Musapatika||317.634.5842 ext email@example.com|
|Contact: Monika Joshi, M.D.||firstname.lastname@example.org|
|United States, Iowa|
|Univeristy of Iowa Hospital and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Marian Anderson 319-353-4578 email@example.com|
|Principal Investigator: Yousef Zakharia, MD|
|United States, Pennsylvania|
|Penn State Cancer Intsitute||Recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Contact: Heather Rutherford 717-531-0003|
|Principal Investigator: Monika Joshi|
|Study Chair:||Monika Joshi, M.D.||Big Ten Cancer Research Consortium|