Clinical trial
An Exploratory Study of the Biologic Effects of Nivolumab and Ipilimumab Monotherapy and Nivolumab in Combination With Ipilimumab Treatment in Subjects With Advanced Melanoma (Unresectable or Metastatic)
Name
CA209-038
Description
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)
Trial arms
Trial start
2012-09-27
Estimated PCD
2017-09-12
Trial end
2018-10-25
Status
Completed
Phase
Early phase I
Treatment
Nivolumab
Arms:
Part 1-Cohort 1 and 2: Nivolumab, Part 2-Arm A: Nivolumab + Ipilimumab, Part 3-Arm A: Nivolumab + Ipilimumab, Part 3-Arm B: Nivolumab, Part 4-Arm D: Nivolumab + Ipilimumab, Part 4-Arm E: Nivolumab
Other names:
BMS-936558 (MDX1106)
Ipilimumab
Arms:
Part 2-Arm A: Nivolumab + Ipilimumab, Part 3-Arm A: Nivolumab + Ipilimumab, Part 4-Arm D: Nivolumab + Ipilimumab
Other names:
BMS734016, Yervoy
Size
170
Primary endpoint
Median Change From Baseline to Week 7, of Interferon (IFN) and Interferon Gamma (IFN-gamma) Inducible Factors
From last non-missing value prior to first dose to week 7 day 1
Tumor Infiltrating Lymphocytes (TILs) as Measured by Medians in Percent Positive CD8 and Positive CD4 at Baseline and On-treatment Biopsy, Both Using the Mosaic Singleplex IHC Assay
From last non-missing value prior to first dose to week 4 day 1
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 170, 'type': 'ACTUAL'}}
Updated at
2024-04-23
1 organization
2 products
2 indications
Organization
Bristol-Myers SquibbProduct
NivolumabIndication
MelanomaIndication
Metastatic MelanomaProduct
Ipilimumab