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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 InstituteTampa, Florida  33612
Local InstitutionBronx, New York  
Local InstitutionCincinnati, Ohio  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionDuluth, Minnesota  
Sarah Cannon Research InstituteNashville, Tennessee  37203