Safety Study of BMS-986015 (Anti-KIR) in Combination With Ipilimumab in Subjects With Selected Advanced Tumor
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | December 2012 |
End Date: | April 2015 |
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
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.
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.
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.
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
- Normal thyroid function or be on stable hormone supplementation
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
- Grade 2 neuropathy
We found this trial at
6
sites
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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12902 USF Magnolia Dr
Tampa, Florida 33612
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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