Multiple Ascending Dose (MDX1105-01) (Anti-PDL1)
September 3, 2015 updated by: Bristol-Myers Squibb
A Phase 1, Multidose Study of BMS-936559 (MDX-1105) Administered Every 14 Days in Subjects With Selected Advanced or Recurrent Solid Tumors
Collection of survival data, evaluation of PDL-1 expression in tumors, and evaluation of PD-L1 receptor occupancy in peripheral blood has been added.
Study Overview
Status
Completed
Conditions
Detailed Description
This is an open label, multicenter, dose escalation and multidose study of MDX-11-5, a fully human monoclonal IgG4 antibody targeting the Programed Death-Ligand 1 (PD-L1).
The study will consist of 3 periods: Screening (up to 28 days), Treatment (up to 16 six-week cycles), and Follow-up (up to 6 months).
Study Type
Interventional
Enrollment (Actual)
281
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90025
- The Angeles Clinic & Research Institute
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago
-
-
Maryland
-
Baltimore, Maryland, United States, 21231
- Johns Hopkins University
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
-
Ohio
-
Cincinnati, Ohio, United States, 45267
- University of Cincinnati
-
Columbus, Ohio, United States, 43210
- Ohio State University
-
-
Texas
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Houston, Texas, United States, 77030
- The University of Texas
-
Houston, Texas, United States, 77024
- Oncology Consultants, PA
-
-
Washington
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Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
- The malignancies include relapsed/refractory renal cell carcinoma, non-small cell lung cancer, colorectal adenocarcinoma, malignant melanoma, advanced/metastatic epithelial ovarian cancer, gastric cancer, pancreatic cancer and breastcancer
- Must have measurable disease
Exclusion Criteria:
- Prior therapy with an anti-PD 1, anti-PDL 1, or anti-Cytotoxic T-Lymphocyte Antigen 4 antibody (or any other agents that target T-cell co-stimulation)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Anti-PDL-1 antibody (Arm 1)
BMS-936559 (MDX-1105)
|
Solution, Intravenous, 0.1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 0.3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 10 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
|
|
EXPERIMENTAL: Anti-PDL-1 antibody (Arm 2)
BMS-936559 (MDX-1105)
|
Solution, Intravenous, 0.1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 0.3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 10 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
|
|
EXPERIMENTAL: Anti-PDL-1 antibody (Arm 3)
BMS-936559 (MDX-1105)
|
Solution, Intravenous, 0.1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 0.3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 10 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
|
|
EXPERIMENTAL: Anti-PDL-1 antibody (Arm 4)
BMS-936559 (MDX-1105)
|
Solution, Intravenous, 0.1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 0.3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 10 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
|
|
EXPERIMENTAL: Anti-PDL-1 antibody (Arm 5)
BMS-936559 (MDX-1105)
|
Solution, Intravenous, 0.1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 0.3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
Solution, Intravenous, 10 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety, maximum tolerated dose (MTD) and dose-limiting toxicity(DLT)of MDX-1105
Time Frame: Weekly
|
Weekly
|
|
Safety, maximum tolerated dose (MTD) and dose-limiting toxicity(DLT)of MDX-1105
Time Frame: Bi-weekly
|
Bi-weekly
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Preliminary efficacy in solid tumors on the basis of objective responses
Time Frame: Day 42
|
Day 42
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (ACTUAL)
July 1, 2015
Study Completion (ACTUAL)
July 1, 2015
Study Registration Dates
First Submitted
August 4, 2008
First Submitted That Met QC Criteria
August 4, 2008
First Posted (ESTIMATE)
August 7, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
September 7, 2015
Last Update Submitted That Met QC Criteria
September 3, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA210-001
- MDX1105-01 (OTHER: BMS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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