BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Ono Pharma USA Inc
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01354431
First received: May 10, 2011
Last updated: December 31, 2014
Last verified: June 2014
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Purpose
The purpose of this study is to measure how active BMS-936558 is against Renal Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response relationship exists.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Cell Carcinoma |
Biological: BMS-936558 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Nivolumab
Genetic and Rare Diseases Information Center resources:
Clear Cell Renal Cell Carcinoma
Kidney Cancer
Renal Cancer
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Progression free survival as measured by tumor assessments (radiographic scans) and the collection of death data. It will be compared to the doses given across the 3 treatment arms to see if a dose response exists. [ Time Frame: Tumor assessments (radiographic scans) will be done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression is documented. Subjects will be assessed for survival every 3 months. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression free survival in the BMS-936558 arms [ Time Frame: Progression free survival will be assessed in each individual treatment arm by tumor assessments every 6 weeks ] [ Designated as safety issue: No ]
- The tumor response rate in the BMS-936558 arms as assessed by the Investigator assessment of best overall response [ Time Frame: Up to 22 months after study start ] [ Designated as safety issue: No ]The tumor response rate will be assessed on all subjects at the time they discontinue study treatment by the Investigators assessment of best overall response for a subject
- The overall survival in the BMS-936558 arms as collected by death data [ Time Frame: The survival in each treatment arm will be assessed by the collection of death data every 3 months following the discontinuation of study therapy until a subjects death ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | April 2015 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1: BMS-936558 - 0.3 mg/kg |
Biological: BMS-936558
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: BMS-936558 - 2.0 mg/kg |
Biological: BMS-936558
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: BMS-936558 - 10.0 mg/kg |
Biological: BMS-936558
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354431
Show 41 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354431
Show 41 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharma USA Inc
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided by Bristol-Myers Squibb
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01354431 History of Changes |
| Other Study ID Numbers: | CA209-010 |
| Study First Received: | May 10, 2011 |
| Last Updated: | December 31, 2014 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Bristol-Myers Squibb:
|
Advanced/Metastatic clear cell component |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Adenocarcinoma Kidney Diseases Kidney Neoplasms Neoplasms |
Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Neoplasms Urologic Diseases Urologic Neoplasms |
ClinicalTrials.gov processed this record on February 25, 2015