BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)
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|ClinicalTrials.gov Identifier: NCT01354431|
Recruitment Status : Completed
First Posted : May 16, 2011
Results First Posted : October 20, 2015
Last Update Posted : May 12, 2022
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Biological: nivolumab||Phase 2|
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Actual Study Start Date :||May 31, 2011|
|Actual Primary Completion Date :||May 15, 2013|
|Actual Study Completion Date :||April 15, 2021|
|Experimental: Arm 1: nivolumab - 0.3 mg/kg||
Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
Other Name: BMS-936558
|Experimental: Arm 2: nivolumab - 2.0 mg/kg||
Solution, Intravenous (IV), 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
Other Name: BMS-936558
|Experimental: Arm 3: nivolumab - 10.0 mg/kg||
Solution, Intravenous (IV), 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
Other Name: BMS-936558
- Progression Free Survival (PFS) [ Time Frame: From randomization to disease progression or death (up to approximately 2 years) ]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.
- Best Overall Response Rate (BORR) [ Time Frame: From randomization until disease progression or discontinuation of study therapy (up to approximately 2 years) ]
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
- Overall Survival (OS) [ Time Frame: From randomization to to date of death (up to approximately 8 years) ]
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.
- Number of Participants Experiencing Adverse Events [ Time Frame: From first dose to 30 days following last dose (up to approximately 6 years) ]
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
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): NCT01354431
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|