Multiple Ascending Dose (MDX1105-01)

NCT ID: NCT00729664

Last Updated: 2015-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2015-07-31

Brief Summary

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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

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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).

Conditions

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Cancer, Multiple Indications

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anti-PDL-1 antibody (Arm 1)

BMS-936559 (MDX-1105)

Group Type EXPERIMENTAL

Anti-PDL-1 antibody

Intervention Type BIOLOGICAL

Solution, Intravenous, 0.1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response

Anti-PDL-1 antibody (Arm 2)

BMS-936559 (MDX-1105)

Group Type EXPERIMENTAL

Anti-PDL-1 antibody

Intervention Type BIOLOGICAL

Solution, Intravenous, 0.3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response

Anti-PDL-1 antibody (Arm 3)

BMS-936559 (MDX-1105)

Group Type EXPERIMENTAL

Anti-PDL-1 antibody

Intervention Type BIOLOGICAL

Solution, Intravenous, 1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response

Anti-PDL-1 antibody (Arm 4)

BMS-936559 (MDX-1105)

Group Type EXPERIMENTAL

Anti-PDL-1 antibody

Intervention Type BIOLOGICAL

Solution, Intravenous, 3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response

Anti-PDL-1 antibody (Arm 5)

BMS-936559 (MDX-1105)

Group Type EXPERIMENTAL

Anti-PDL-1 antibody

Intervention Type BIOLOGICAL

Solution, Intravenous, 10 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response

Interventions

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Anti-PDL-1 antibody

Solution, Intravenous, 0.1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response

Intervention Type BIOLOGICAL

Anti-PDL-1 antibody

Solution, Intravenous, 0.3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response

Intervention Type BIOLOGICAL

Anti-PDL-1 antibody

Solution, Intravenous, 1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response

Intervention Type BIOLOGICAL

Anti-PDL-1 antibody

Solution, Intravenous, 3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response

Intervention Type BIOLOGICAL

Anti-PDL-1 antibody

Solution, Intravenous, 10 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response

Intervention Type BIOLOGICAL

Other Intervention Names

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BMS-936559 MDX 1105 BMS-936559 MDX 1105 BMS-936559 MDX 1105 BMS-936559 MDX 1105 BMS-936559 MDX 1105

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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The Angeles Clinic & Research Institute

Los Angeles, California, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

University Of Chicago

Chicago, Illinois, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

University Of Cincinnati

Cincinnati, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Oncology Consultants, Pa

Houston, Texas, United States

Site Status

The University Of Texas

Houston, Texas, United States

Site Status

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2.

Reference Type DERIVED
PMID: 22658128 (View on PubMed)

Related Links

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Other Identifiers

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MDX1105-01

Identifier Type: OTHER

Identifier Source: secondary_id

CA210-001

Identifier Type: -

Identifier Source: org_study_id

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