Renal Cell Carcinoma Clinical Trial
Official title:
A Randomized, Blinded, Phase 2 Dose-Ranging Study Of BMS-936558 (MDX-1106) In Subjects With Progressive, Advanced/Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy
Verified date | May 2022 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to measure how active BMS-936558 (nivolumab) is against Renal Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response relationship exists.
Status | Completed |
Enrollment | 168 |
Est. completion date | April 15, 2021 |
Est. primary completion date | May 15, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologic confirmation of Renal cell carcinoma (RCC) with a clear cell component - Previous treatment with at least one anti-angiogenic agent - Progressed within 6 months of study enrollment - Subjects should not have had more than 3 prior treatments for locally advanced or metastatic disease - Must have available tumor tissue for submission - Subjects must also meet various laboratory parameters for inclusion Exclusion Criteria: - Subjects with any active autoimmune disease or a history of known autoimmune disease Other protocol-defined inclusion/exclusion criteria apply |
Country | Name | City | State |
---|---|---|---|
Canada | Tom Baker Cancer Centre | Calgary | Alberta |
Canada | Local Institution | Halifax | Nova Scotia |
Canada | London Regional Cancer Program | London | Ontario |
Canada | Centre D'Oncologie Dr-Leon-Richard | Moncton | New Brunswick |
Canada | Centre Hospitalier Universitaire De Montreal-Notre-Dame Hosp | Montreal | Quebec |
Finland | Local Institution | Helsinki | |
Italy | Local Institution | Siena | |
United States | University Of Michigan Medical Center | Ann Arbor | Michigan |
United States | University Of Colorado | Aurora | Colorado |
United States | The Bunting-Blaustein Cancer Research Building | Baltimore | Maryland |
United States | University Of Maryland | Baltimore | Maryland |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Beth Israel Deaconess Medical Ctr. | Boston | Massachusetts |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Medical University Of South Carolina | Charleston | South Carolina |
United States | Blumenthal Cancer Center | Charlotte | North Carolina |
United States | Northwestern University Feinberg School Of Medicine | Chicago | Illinois |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Wayne State University | Detroit | Michigan |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Indiana University Health Melvin And Bren Simon Cancer Center | Indianapolis | Indiana |
United States | University Of Kansas Medical Center | Kansas City | Kansas |
United States | UCSD Moores Cancer Center | La Jolla | California |
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Samuel Oschin Comprehensive Cancer Inst. | Los Angeles | California |
United States | Ucla | Los Angeles | California |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Masonic Cancer Ctr, University Of Minnesota | Minneapolis | Minnesota |
United States | Tennessee Oncology, PLLC | Nashville | Tennessee |
United States | Vanderbilt-Ingram Cancer Ctr | Nashville | Tennessee |
United States | Memorial Sloan Kettering Nassau | New York | New York |
United States | Mount Sinai Medical Center | New York | New York |
United States | St. Luke'S Roosevelt Hospital Center | New York | New York |
United States | Weill Cornell Medical College | New York | New York |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | University Of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Washington - Seattle Cancer Care Alliance | Seattle | Washington |
United States | Stanford Cancer Center | Stanford | California |
United States | North Mississippi Hematology And Oncology Associates, Ltd | Tupelo | Mississippi |
United States | Georgetown University Medical Center | Washington | District of Columbia |
United States | Wheaton Franciscan Health Care | Wauwatosa | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb | Ono Pharma USA Inc |
United States, Canada, Finland, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival (PFS) | PFS is defined as the time from randomization to date of first disease progression (either clinical or radiographic progression, as assessed by the investigator). Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. Survival was assessed every 3 months. The analysis of PFS was conducted after approximately 116 events (progression or death), approximately 2 years. PFS was calculated based on investigator's assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions. | From randomization to disease progression or death (up to approximately 2 years) | |
Secondary | Best Overall Response Rate (BORR) | BORR is defined as the percentage of participants whose best response is either partial response (PR) or complete response (CR). Tumor response was evaluated by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 80% confidence interval is based on the Clopper and Pearson method |
From randomization until disease progression or discontinuation of study therapy (up to approximately 2 years) | |
Secondary | Overall Survival (OS) | OS is defined as the time from date of randomization until date of death. If the participant did not die, overall survival will be censored on the last date the participant was known to be alive. Survival status is collected at each visit during treatment and every 3 months during follow-up.
OS is based on Kaplan-Meier estimates. |
From randomization to to date of death (up to approximately 8 years) | |
Secondary | Number of Participants Experiencing Adverse Events | Number of participants experiencing different types of events, including Adverse Events (AEs), Drug-related AEs, AEs leading to discontinuation, Drug-related AEs leading to discontinuation, Serious Adverse Events (SAEs), Drug-related SAEs.
Events are classified based on the NCI Common Terminology Criteria (CTC) version 4.0 |
From first dose to 30 days following last dose (up to approximately 6 years) |
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