BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ono Pharma USA Inc
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01354431
First received: May 10, 2011
Last updated: July 23, 2014
Last verified: June 2014
  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:


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: November 2014
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
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: July 23, 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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014