|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
23 May 2022 |
|
Main ID: |
NCT01354431 |
|
Date of registration:
|
10/05/2011 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)
|
|
Scientific 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 |
|
Date of first enrolment:
|
May 31, 2011 |
|
Target sample size:
|
168 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01354431 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Belgium
|
Canada
|
Finland
|
Italy
|
Spain
|
United States
| | |
|
Contacts
|
|
Name:
|
Bristol-Myers Squibb |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Bristol-Myers Squibb |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Renal Cell Carcinoma
|
|
Intervention(s)
|
|
Biological: nivolumab
|
|
Primary Outcome(s)
|
|
Progression Free Survival (PFS)
[Time Frame: From randomization to disease progression or death (up to approximately 2 years)]
|
|
Secondary Outcome(s)
|
|
Number of Participants Experiencing Adverse Events
[Time Frame: From first dose to 30 days following last dose (up to approximately 6 years)]
|
|
Best Overall Response Rate (BORR)
[Time Frame: From randomization until disease progression or discontinuation of study therapy (up to approximately 2 years)]
|
|
Overall Survival (OS)
[Time Frame: From randomization to to date of death (up to approximately 8 years)]
|
|
Secondary ID(s)
|
|
CA209-010
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|