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An Exploratory Study to Investigate the Immunomodulatory Activity of Various Dose Levels of Anti Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Subjects With Metastatic Clear Cell Renal Cell Carcinoma (RCC).


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma

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Trial Information

An Exploratory Study to Investigate the Immunomodulatory Activity of Various Dose Levels of Anti Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Subjects With Metastatic Clear Cell Renal Cell Carcinoma (RCC).


Intervention Model: Parallel Dose Comparison


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:



- Women and men ≥ 18 years of age.

- Histologic confirmation of renal cell carcinoma with a clear cell component.

- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors
(RECIST).

- Tumor sites that can be accessed for repeat biopsies at acceptable clinical risk.

- Previously treated subjects must have failed at least 1 prior anti-angiogenic agent
and can have a maximum of 3 prior systemic treatments for renal cell cancer.

- Subjects in the treatment naive arm cannot have received prior systemic therapy for
their renal cell carcinoma.

Exclusion Criteria:

- Active or progressing brain metastases.

- Active concomitant.

- Active or history of autoimmune disease.

- Active use of systemic corticosteroids.

- Prior therapy with Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4), anti
Programmed death-1 (anti-PD1), anti Programmed death ligand 1 (anti-PD-L1), anti
Programmed death ligand 2 (anti-PD-L2), anti-CD137, anti-CD40, anti-OX40 antibodies.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Immunomodulatory activity as measured by the functional and phenotypic characterization of peripheral immune cells, modulation/changes in soluble factors, and the characterization of tumor immune infiltrates and the expression of tumor markers

Outcome Description:

Immunomodulation across the 4 treatment arms will be evaluated to explore these measures at multiple doses

Outcome Time Frame:

Biomarker samples will be collected prior to the first study treatment through up to 24 weeks following initiation of study treatment

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:

CA209-009

NCT ID:

NCT01358721

Start Date:

September 2011

Completion Date:

August 2015

Related Keywords:

  • Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Duke University Medical CenterDurham, North Carolina  27710
University of Chicago Medical CenterChicago, Illinois  60637
H Lee Moffitt Cancer CenterTampa, Florida  33612
Yale University School Of MedicineNew Haven, Connecticut  06520
UPMC Cancer PavilionPittsburgh, Pennsylvania  15232
Providence Portland Med CtrPortland, Oregon  97213
University of Wisconsin Carbone Cancer CenterMadison, Wisconsin  53792-5669
The Bunting-Blaustein Cancer Research BuildingBaltimore, Maryland  21231
Dana Farber Cancer InstBoston, Massachusetts  02215