NCT00729664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
281

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_1

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

6.4 years

First QC Date

August 4, 2008

Last Update Submit

September 3, 2015

Conditions

Cancer, Multiple Indications

Outcome Measures

Primary Outcomes (2)

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

    Weekly

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

    Bi-weekly

Secondary Outcomes (1)

  • Preliminary efficacy in solid tumors on the basis of objective responses

    Day 42

Study Arms (5)

Anti-PDL-1 antibody (Arm 1)

EXPERIMENTAL

BMS-936559 (MDX-1105)

Biological: Anti-PDL-1 antibody

Anti-PDL-1 antibody (Arm 2)

EXPERIMENTAL

BMS-936559 (MDX-1105)

Biological: Anti-PDL-1 antibody

Anti-PDL-1 antibody (Arm 3)

EXPERIMENTAL

BMS-936559 (MDX-1105)

Biological: Anti-PDL-1 antibody

Anti-PDL-1 antibody (Arm 4)

EXPERIMENTAL

BMS-936559 (MDX-1105)

Biological: Anti-PDL-1 antibody

Anti-PDL-1 antibody (Arm 5)

EXPERIMENTAL

BMS-936559 (MDX-1105)

Biological: Anti-PDL-1 antibody

Interventions

Anti-PDL-1 antibodyBIOLOGICAL

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

Also known as: BMS-936559, MDX 1105
Anti-PDL-1 antibody (Arm 1)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

The Angeles Clinic & Research Institute

Los Angeles, California, 90025, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University Of Chicago

Chicago, Illinois, 60637, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21231, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

University Of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oncology Consultants, Pa

Houston, Texas, 77024, United States

Location

The University Of Texas

Houston, Texas, 77030, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • 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.

    PMID: 22658128DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

BMS-936559

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2008

First Posted

August 7, 2008

Study Start

February 1, 2009

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

US(11)