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A Phase 1 Study of BMS-986015, an Anti-KIR Monoclonal Antibody, Administered With Ipilimumab, an Anti-CTLA4 Monoclonal Antibody, in Subjects With Select Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
CANCER, NOS

Thank you

Trial Information

A Phase 1 Study of BMS-986015, an Anti-KIR Monoclonal Antibody, Administered With Ipilimumab, an Anti-CTLA4 Monoclonal Antibody, in Subjects With Select Advanced Solid Tumors


Inclusion Criteria:



- Histologic confirmation of one of the following solid tumors that is advanced
(unresectable or metastatic) for dose escalation or cohort expansion:Non-Small Cell
Lung Cancer (NSCLC), Castrate Resistant Prostate Cancer (CRPC), Melanoma (MEL)

- 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

- Biopsies: Subjects in the melanoma cohort must have at least 1 tumor site that can be
biopsied at acceptable clinical risk

- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1

- Estimated life expectancy of ≥ 12 weeks

- White blood cell (WBC) ≥2000/μL, Neutrophils ≥1500/μL, Platelets ≥ 100x1000/μL,
Hemoglobin ≥ 8.5 g/dL, creatinine ≤ 1.5 X upper limit of normal (ULN) mL/min,
Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3x ULN

Exclusion Criteria:

- Participation in any prior clinical study with BMS-936558 or ipilimumab that has
overall survival listed as a primary/co-primary endpoint

- Subjects with known or suspected brain metastasis

- Subjects with active autoimmune disease, uncontrolled or significant cardiovascular
disease

- Prior therapy with anti- Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) antibody or anti-
Killer cell immunoglobulin-like receptor (KIR) antibody

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety as measured by the rate of adverse events, and serious adverse events

Outcome Time Frame:

Up to a maximum of 1.4 years (treatment period)

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Institutional Review Board

Study ID:

CA223-002

NCT ID:

NCT01750580

Start Date:

January 2013

Completion Date:

July 2015

Related Keywords:

  • CANCER, NOS

Name

Location

H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
Local Institution Bronx, New York  
Local Institution Cincinnati, Ohio  
Local Institution Fort Lauderdale, Florida  
Local Institution Springfield, Massachusetts  
Local Institution Duluth, Minnesota  
Sarah Cannon Research Institute Nashville, Tennessee  37203