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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03451331
Other study ID # HCRN GU16-287
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 10, 2018
Est. completion date July 28, 2023

Study information

Verified date April 2024
Source Hoosier Cancer Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized phase 2 trial of gemcitabine + carboplatin + nivolumab or gemcitabine + oxaliplatin + nivolumab for the treatment of cisplatin-ineligible patients with metastatic urothelial cancer. Randomization will be stratified on the lymph node only (and/or unresectable primary) metastatic status.


Description:

Patients will be randomized to Arm A: gemcitabine plus carboplatin plus nivolumab versus Arm B: gemcitabine plus oxaliplatin plus nivolumab. Randomization will be stratified on the metastasis status (lymph node only vs. the rest). Patients on both treatment arms will receive up to 6 cycles of combination therapy in the absence of prohibitive adverse effects or disease progression. Patients with at least stable disease at the completion of 6 cycles of treatment may continue "maintenance" single agent nivolumab for up to 12 cycles. Patients who require discontinuation of chemotherapy (i.e., gemcitabine plus carboplatin or gemcitabine plus oxaliplatin) prior to Cycle 6, but who have at least stable disease, may be considered for ongoing treatment with single-agent nivolumab on the "maintenance" phase after discussion with the sponsor-investigator.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nivolumab
Nivolumab 360mg (and/or) Maintenance Single Agent Nivolumab 480mg (starting ~ 2-4 weeks after completing combination chemotherapy plus nivolumab)
Gemcitabine
1000 mg/m^2
Carboplatin
AUC 4.5 (based on the Calvert formula)
Oxaliplatin
130 mg/m^2

Locations

Country Name City State
United States Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland
United States John Theuer Cancer Center Hackensack New Jersey
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center New York New York
United States Huntsman Cancer Institute University of Utah Salt Lake City Utah

Sponsors (3)

Lead Sponsor Collaborator
Matthew Galsky Bristol-Myers Squibb, Hoosier Cancer Research Network

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD.
ORR is defined as the percentage of patients who achieve a response (confirmed PR or CR) according to RECIST 1.1.
Up to a maximum of 50 months
Secondary Adverse Events The frequency and severity of grade 3+ treatment emergent adverse events are reported by CTCAEv4 term and grade. AE had been recorded from time of signed informed consent until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 19 months.
Secondary Duration of Response (DOR) DOR was defined as the period measured from the date that evaluation criteria were met for CR or PR (whichever status was recorded first) until the date that recurrence or PD was objectively documented. Up to a maximum of 50 months
Secondary Progression-Free Survival (PFS) Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as time from registration until disease progression met by RECIST 1.1 or death from any cause. Up to maximum of 50 months
Secondary Overall Survival (OS) Overall survival is defined as the time from randomization until death or date of last contact. Up to a maximum of 53 months
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