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Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma

NCT01489059 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2014-08-29

No results posted yet for this study

Summary

The purpose of this study is to determine whether the combination of interleukin-21 (IL-21) and Ipilimumab in subjects with melanoma is safe, and provide preliminary information on the clinical benefits of the combination compared with Ipilimumab alone

Conditions

Interventions

BIOLOGICAL

BMS-982470 (recombinant interleukin-21)

Solution, Intravenous, 10,30,50 μg/kg, daily for 5 days every 3 weeks (daily x 5), 16-20 weeks depending on response

BIOLOGICAL

BMS-982470 (recombinant interleukin-21)

Solution, Intravenous, 30,100,150 μg/kg, weekly, 16-20 weeks depending on response

BIOLOGICAL

BMS-982470 (recombinant interleukin-21)

Solution, Intravenous, Maximum tolerated dose from Part 1, daily for 5 days every 3 weeks (daily x 5), 12-16 weeks depending on response

BIOLOGICAL

BMS-982470 (recombinant interleukin-21)

Solution, Intravenous, Maximum tolerated dose from Part 1, Weekly, 12-16 weeks depending on response

BIOLOGICAL

Ipilimumab

Solution, Intravenous, 1,3,10 mg/kg, every 3 weeks, 16-20 weeks depending on response

BIOLOGICAL

Ipilimumab

Solution, Intravenous, Maximum tolerated dose from Part 1, every 3 weeks, 12-16 weeks depending on response

BIOLOGICAL

Ipilimumab

Solution, Intravenous, 3mg/kg, Every 3 weeks, 12-16 weeks depending on response

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01489059 on ClinicalTrials.gov