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Phase 1 Biomarker Study of Anti-PDL-1 in Advanced Melanoma

NCT01455103 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2011-12-13

No results posted yet for this study

Summary

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.

Conditions

  • Stage III or IV Melanoma

Interventions

BIOLOGICAL

BMS-936559 (Anti-PD-L1)

Solution, Intravenous infusion, 1 mg/kg, Every 2 weeks, Up to 2 years, depending on response

BIOLOGICAL

BMS-936559 (Anti-PD-L1)

Solution, Intravenous infusion, 3 mg/kg, Every 2 weeks, Up to 2 years, depending on response

BIOLOGICAL

BMS-936559 (Anti-PD-L1)

Solution, Intravenous infusion, 10 mg/kg, Every 2 weeks, Up to 2 years, depending on response

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-11-30
Completion
2013-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01455103 on ClinicalTrials.gov