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Cancer, Multiple IndicationsPhase 1Anti-PDL1NCT00729664

Multiple Ascending Dose (MDX1105-01)

A Phase 1 study testing Anti-PDL-1 antibody in people with Cancer, Multiple Indications, run by Bristol-Myers Squibb at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Multiple Indications
What is being tested?
Anti-PDL-1 antibody
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
281 participants
Where
11 sitesUnited States
Study dates
Feb 2009to Jul 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Johns Hopkins University

    Baltimore, Maryland, 21231

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University Of Chicago

    Chicago, Illinois, 60637

  • University Of Cincinnati

    Cincinnati, Ohio, 45267

  • Ohio State University

    Columbus, Ohio, 43210

  • Oncology Consultants, Pa

    Houston, Texas, 77024

  • The University Of Texas

    Houston, Texas, 77030

  • The Angeles Clinic & Research Institute

    Los Angeles, California, 90025

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: 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.

Read the 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).

Being tested
Anti-PDL-1 antibody
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-PDL-1 antibodyBiological

    Also called 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

  • Anti-PDL-1 antibodyBiological

    Also called BMS-936559, MDX 1105

    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 antibodyBiological

    Also called BMS-936559, MDX 1105

    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 antibodyBiological

    Also called BMS-936559, MDX 1105

    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 antibodyBiological

    Also called BMS-936559, MDX 1105

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

Study groups in NCT00729664
Study groupRoleWhat they receive
Anti-PDL-1 antibody (Arm 1)ExperimentalBMS-936559 (MDX-1105)
Receives: Biological: Anti-PDL-1 antibody
Anti-PDL-1 antibody (Arm 2)ExperimentalBMS-936559 (MDX-1105)
Receives: Biological: Anti-PDL-1 antibody
Anti-PDL-1 antibody (Arm 3)ExperimentalBMS-936559 (MDX-1105)
Receives: Biological: Anti-PDL-1 antibody
Anti-PDL-1 antibody (Arm 4)ExperimentalBMS-936559 (MDX-1105)
Receives: Biological: Anti-PDL-1 antibody
Anti-PDL-1 antibody (Arm 5)ExperimentalBMS-936559 (MDX-1105)
Receives: Biological: Anti-PDL-1 antibody

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Weekly

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

    Measured: Bi-weekly

Secondary outcomes (1)

  1. Preliminary efficacy in solid tumors on the basis of objective responses

    Measured: Day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2008 (estimated)
  2. Study startFeb 2009
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
281 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00729664
Sponsor's protocol ID
CA210-001
Other IDs
MDX1105-01
Acronym
Anti-PDL1
Status last verified
Sep 2015
First submitted
4 Aug 2008
Last updated
7 Sep 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22658128

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anti-PDL-1 antibody in people with Cancer, Multiple Indications, run by Bristol-Myers Squibb at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety, maximum tolerated dose (MTD) and dose-limiting toxicity(DLT)of MDX-1105 (time frame: Weekly). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00729664, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2015.

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