BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354431
• Other study ID #: CA209-010
• Status: Completed
• Phase: Phase 2
• Start date: May 31, 2011
• Est. completion date: April 15, 2021

Study information

• Verified date: May 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Biological:
• nivolumab
Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
• nivolumab
Solution, Intravenous (IV), 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
• nivolumab
Solution, Intravenous (IV), 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharma USA Inc

Countries where clinical trial is conducted

United States,  Canada,  Finland,  Italy, 

Outcome

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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