Melanoma Clinical Trial

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

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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

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Full Description

Allocation: Part 1 Dose Escalation Phase: Non-randomized; Part 2 Cohort Expansion Phase: Randomized

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Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

Unresectable Stage III or Stage IV melanoma
Part 1 Dose Escalation: Prior melanoma treatment allowed except for the following: ipilimumab, BMS-982470 (rIL-21), anti-Programmed Death-1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), anti-PD-L2 or anti-CD137
Part 2 Cohort expansion: Prior treatment for melanoma is not allowed, except for adjuvant therapy with interferon alpha or melanoma vaccines which are permitted
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
Normal liver function tests

Exclusion Criteria:

Part 1 Dose escalation: subjects with ≤ 2 brain metastases of stable size, ≥ 4 weeks post-radiation treatment, and off steroids are allowed
Part 2 Cohort expansion: subjects with known or suspected brain metastases and uveal melanoma are excluded
Autoimmune disease

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

42

Study ID:

NCT01489059

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 9 Locations for this study

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Oncology Research Associates, Pllc D/B/A
Scottsdale Arizona, 85258, United States
Ucla Hematology/Oncology.
Los Angeles California, 90095, United States
H. Lee Moffitt Cancer Center & Research Inst, Inc
Tampa Florida, 33612, United States
Indiana University Health Melvin And Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
University Of Louisville Medical Center, Inc., Dba
Louisville Kentucky, 40202, United States
Portland Providence Medical Center
Portland Oregon, 97213, United States
Md Anderson Can Cnt
Houston Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Local Institution
San Juan , 00927, Puerto Rico
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How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

42

Study ID:

NCT01489059

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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