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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma

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Trial Information

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


For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

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.

Outcome 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.

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA209-010

NCT ID:

NCT01354431

Start Date:

May 2011

Completion Date:

June 2014

Related Keywords:

  • Renal Cell Carcinoma
  • Advanced/Metastatic
  • clear cell component
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Loyola University Medical CenterMaywood, Illinois  60153
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Mount Sinai Medical CenterNew York, New York  10029
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
University of ColoradoDenver, Colorado  80217
Stanford Cancer CenterStanford, California  94305-5824
Seattle Cancer Care AllianceSeattle, Washington  98109
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Duke University Medical CenterDurham, North Carolina  27710
University of Michigan Medical CenterAnn Arbor, Michigan  48104-0914
Cleveland ClinicCleveland, Ohio  44195
Wayne State UniversityDetroit, Michigan  48202
University of MarylandBaltimore, Maryland  21201
Blumenthal Cancer CenterCharlotte, North Carolina  28203
Georgetown University Medical CenterWashington, District of Columbia  20007
UCLALos Angeles, California  90095
UCSD Moores Cancer CenterLa Jolla, California  93093
Northwestern University Feinberg School of MedicineChicago, Illinois  60611
Tennessee Oncology, PLLCClarksville, Tennessee  37043
St. Luke's Roosevelt Hospital CenterNew York, New York  10019
Weill Cornell Medical CollegeNew York, New York  10021
Vanderbilt-Ingram Cancer CtrNashville, Tennessee  37232
The Bunting Blaustein Cancer Research BuildingBaltimore, Maryland  21231
North Mississippi Hematology And Oncology Associates, LtdTupelo, Mississippi  38801
Masonic Cancer Ctr, University Of MinnesotaMinneapolis, Minnesota  55455
Samuel Oschin Comprehensive Cancer Inst.Los Angeles, California  90048
Wheaton Franciscan Health CareWauwatosa, Wisconsin  53226
Beth Israel Deaconess Medical Ctr.Boston, Massachusetts  02215