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A Phase 1, Multidose Study of BMS-936559 (MDX-1105) Administered Every 14 Days in Subjects With Selected Advanced or Recurrent Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Cancer, Multiple Indications

Thank you

Trial Information

A Phase 1, Multidose Study of BMS-936559 (MDX-1105) Administered Every 14 Days in Subjects With Selected Advanced or Recurrent Solid Tumors


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).


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety, maximum tolerated dose (MTD) and dose-limiting toxicity(DLT)of MDX-1105

Outcome Time Frame:

Weekly

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA210-001

NCT ID:

NCT00729664

Start Date:

April 2009

Completion Date:

December 2013

Related Keywords:

  • Cancer, Multiple Indications

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
Emory UniversityAtlanta, Georgia  30322
Ohio State UniversityColumbus, Ohio  43210
The Angeles Clinic & Research InstituteLos Angeles, California  90404
University of ChicagoChicago, Illinois  60637
Fred Hutchinson Cancer CenterSeattle, Washington  98109
University of CincinnatiCincinnati, Ohio  45267-0502
Oncology Consultants, PAHouston, Texas  77024
The University of TexasHouston, Texas  77030