Multiple Ascending Dose (MDX1105-01)

Phase 1

Completed

• Conditions: Cancer, Multiple Indications
• Interventions: Biological: Anti-PDL-1 antibody

• Registration Number: NCT00729664
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

Collection of survival data, evaluation of PDL-1 expression in tumors, and evaluation of PD-L1 receptor occupancy in peripheral blood has been added.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-08-04
• Study First Submitted QC: 2008-08-04
• Study First Posted: 2008-08-07
• Study Start: 2009-02
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-03
• Last Update Posted: 2015-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anti-PDL-1 antibody (Arm 2)	Anti-PDL-1 antibody	BMS-936559 (MDX-1105)
Anti-PDL-1 antibody (Arm 3)	Anti-PDL-1 antibody	BMS-936559 (MDX-1105)
Anti-PDL-1 antibody (Arm 1)	Anti-PDL-1 antibody	BMS-936559 (MDX-1105)
Anti-PDL-1 antibody (Arm 4)	Anti-PDL-1 antibody	BMS-936559 (MDX-1105)
Anti-PDL-1 antibody (Arm 5)	Anti-PDL-1 antibody	BMS-936559 (MDX-1105)

Primary Outcome Measures

Name	Time	Method
Safety, maximum tolerated dose (MTD) and dose-limiting toxicity(DLT)of MDX-1105	Bi-weekly

Secondary Outcome Measures

Name	Time	Method
Preliminary efficacy in solid tumors on the basis of objective responses	Day 42

Trial Locations

Locations (11)

Emory University; 🇺🇸 Atlanta, Georgia, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

The University Of Texas; 🇺🇸 Houston, Texas, United States

Fred Hutchinson Cancer Center; 🇺🇸 Seattle, Washington, United States

The Angeles Clinic & Research Institute; 🇺🇸 Los Angeles, California, United States

University Of Chicago; 🇺🇸 Chicago, Illinois, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

University Of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Oncology Consultants, Pa; 🇺🇸 Houston, Texas, United States