Safety Study of BMS-986015 (Anti-KIR) in Combination With Ipilimumab in Subjects With Selected Advanced Tumor

Completed · Phase 1

Conditions studied: CANCER, NOS

In brief

To assess the safety and tolerability, characterize the dose-limiting toxicities (DLTs), and identify the maximally tolerated dose (MTD) of BMS-986015 given in combination with ipilimumab in subjects with select advanced (metastatic and/or unresectable) solid tumors.

Key facts

Study ID

NCT01750580

Run by

Bristol-Myers Squibb

People needed

22

Starts

2012-12-01

Expected to finish

2015-04-01

Last updated by the study team

2015-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Normal thyroid function or be on stable hormone supplementation

You may not qualify if…

• 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
• Grade 2 neuropathy

Where it is running

• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University Of Minnesota — Minneapolis, Minnesota, United States
• Memorial Sloan Kettering Cancer Ctr — New York, New York, United States
• The Ohio State University — Columbus, Ohio, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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