Melanoma Clinical Trial

PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma

Summary

The purpose of this study is to evaluate pharmacodynamic changes of Nivolumab and Nivolumab in combination with Ipilimumab treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with advanced melanoma (unresectable or advanced)

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Full Description

Allocation:

Part 1 and 2: Single Arm study

Part 3 and 4: Randomized Controlled Trial

Intervention Model:

Part 1 and 2: Single group: Single arm study

Part 3 and 4: Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study

Minimum Age:

Part 1: 18

Part 2, 3 and 4: 16

View Eligibility Criteria

Eligibility Criteria

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

Part 1:

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-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40,and anti-CD40 antibodies. However, half the patients must have progressed on anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4) monoclonal antibody therapy

Part 2, 3 and 4:

Inclusion Criteria

Men and women >16 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
Subjects must never received anti-CTLA4 therapy
Subjects must have histologic or cytologic confirmation of advanced melanoma
Subjects must have at least two measurable lesions at baseline by CT or MRI as per 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
Subjects in Part 4 must have brain metastases

Exclusion Criteria

Active or progressing brain metastases (except for Part 4 subjects)
Other concomitant malignancies (with some exceptions per protocol)
Active or history of autoimmune disease
Positive test for HIV 1&2 or known AIDS
History of any hepatitis
Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40,and anti-CD40 antibodies

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

170

Study ID:

NCT01621490

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 12 Locations for this study

See Locations Near You

Ucla
Los Angeles California, 90095, United States
University Of Chicago
Chicago Illinois, 60637, United States
Sidney kimmel comprehensive cancer center at johns hopkins
Lutherville Maryland, 21093, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Massachusetts General Hospital
Boston Massachusetts, 02215, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Vanderbilt-Ingram Cancer Ctr
Nashville Tennessee, 37232, United States
The University Of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
University Of Virginia
Charlottesville Virginia, 22908, United States
University of Washington - Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Local Institution - 0016
Amsterdam , 1066 , Netherlands
Local Institution - 0008
Pamplona , 31192, Spain

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

170

Study ID:

NCT01621490

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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