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Completed

NCT Number: NCT00729664

Multiple Ascending Dose (MDX1105-01)

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

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Key information

Conditions

Cancer, Multiple Indications Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Angeles Clinic & Research Institute, Los Angeles, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Anti-PDL-1 antibody

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

Other names: BMS-936559, MDX 1105

Primary outcomes

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

    Time frame: Weekly

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

    Time frame: Bi-weekly

Secondary outcomes

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

    Time frame: Day 42

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: Anti-PDL1

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Aug 7, 2008
Registry last updated
Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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