Trial record 2 of 2 for:    MDX-1105

Phase 1 Biomarker Study of Anti-PDL-1 in Advanced Melanoma (PD-L1)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01455103
First received: October 18, 2011
Last updated: December 12, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to evaluate pharmacodynamic changes of BMS-936559 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with unresectable Stage III or IV Melanoma.


Condition Intervention Phase
Stage III or IV Melanoma
Biological: BMS-936559 (Anti-PD-L1)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase I Study of the Biologic Effects of BMS-936559 Treatment in Subjects With Unresectable Stage III or IV Melanoma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Evidence of immunomodulatory effects of BMS-936559 as measured by changes from baseline in biomarkers assessed 1) peripheral blood assays including flow cytometry and soluble factors and 2) tumor based assays including immunohistochemistry [ Time Frame: Baseline and within the first 24 weeks of study participation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of BMS-936559 as measured by the incidence of adverse events (AEs), serious AEs, laboratory test abnormalities, and changes in vital signs [ Time Frame: Every 2 weeks until 70 days after last treatment ] [ Designated as safety issue: Yes ]
  • Antitumor Activity of BMS-936559 as measured by the objective response rate, disease control rate, duration of response, and progression free survival [ Time Frame: Every 6 weeks for 1 year, every 12 weeks thereafter until confirmed disease progression ] [ Designated as safety issue: No ]
  • Immunogenicity of BMS-936559 as measured by the frequency of subjects with an increase in anti-drug antibody levels from baseline [ Time Frame: Baseline, Week 6, Week 12, and then every 12 weeks until follow-up ] [ Designated as safety issue: Yes ]
  • Pharmacodynamic activity of BMS-936559 as measured by changes from baseline of the tetramer assay in HLA-A*0210 positive subject only [ Time Frame: Predose (screening) and Cycle 3 Day 1 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: BMS-936559 (1mg/kg) Biological: BMS-936559 (Anti-PD-L1)
Solution, Intravenous infusion, 1 mg/kg, Every 2 weeks, Up to 2 years, depending on response
Other Name: MDX1105
Experimental: Arm 2: BMS-936559 (3mg/kg) Biological: BMS-936559 (Anti-PD-L1)
Solution, Intravenous infusion, 3 mg/kg, Every 2 weeks, Up to 2 years, depending on response
Other Name: MDX1105
Experimental: Arm 3: BMS-936559 (10mg/kg) Biological: BMS-936559 (Anti-PD-L1)
Solution, Intravenous infusion, 10 mg/kg, Every 2 weeks, Up to 2 years, depending on response
Other Name: MDX1105

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) status = 0 to 1
  • Subjects with unresectable Stage III or IV Melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic Melanoma
  • Subject must have histologic or cytologic confirmation of advanced Melanoma
  • Subjects must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies

Exclusion Criteria:

  • Active or progressing brain metastases
  • Other concomitant malignancies (with some exceptions per protocol)
  • Active or history of autoimmune disease
  • Positive test for human immunodeficiency virus (HIV) 1&2 or known acquired immunodeficiency syndrome (AIDS)
  • History of any hepatitis
  • Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti Programmed cell death 1 (PD-1), anti Programmed cell death ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40 or anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibodies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455103

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01455103     History of Changes
Other Study ID Numbers: CA210-002
Study First Received: October 18, 2011
Last Updated: December 12, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 23, 2014