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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01750580
First Posted: December 17, 2012
Last Update Posted: July 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
December 6, 2012
December 17, 2012
July 22, 2015
December 2012
April 2015   (Final data collection date for primary outcome measure)
Safety as measured by the rate of adverse events, and serious adverse events [ Time Frame: Approximately 510 days ]
  • Safety as measured by the rate of adverse events, and serious adverse events [ Time Frame: Up to a maximum of 1.4 years (treatment period) ]
  • Safety as measured by the rate of adverse events, and serious adverse events [ Time Frame: 90 days (follow-up) ]
Complete list of historical versions of study NCT01750580 on ClinicalTrials.gov Archive Site
  • Efficacy as measured by tumor assessment [ Time Frame: Assessed from the start of treatment (ay 1) to the end of treatment (week 60) and for 90 days in follow-up ]
  • The maximum observed serum concentration (Cmax) of BMS-986015 and Ipilimumab [ Time Frame: up to 18 timepoints following each dose during Weeks 1, (0h, EOI and 24h), 2, 3, 4, 10, (0h, EOI and 24h), 11, 13, 24, (0h and EOI), 36, 48, 60, follow-up 1 and follow-up 2. (EOI is end of infusion, EOT is end of treatment ]
  • The time of maximum observed serum concentration (Tmax) of BMS-986015 and Ipilimumab [ Time Frame: up to 18 timepoints following each dose during Weeks 1, (0h, EOI and 24h), 2, 3, 4, 10, (0h, EOI and 24h), 11, 13, 24, (0h and EOI), 36, 48, 60, follow-up 1 and follow-up 2 ]
  • Area under the serum concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986015 and Ipilimumab [ Time Frame: up to 18 timepoints following each dose during Weeks 1, (0h, EOI and 24h), 2, 3, 4, 10, (0h, EOI and 24h), 11, 13, 24, (0h and EOI), 36, 48, 60, follow-up 1 and follow-up 2 ]
  • Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986015 and Ipilimumab [ Time Frame: up to 18 timepoints following each dose during Weeks 1, (0h, EOI and 24h), 2, 3, 4, 10, (0h, EOI and 24h), 11, 13, 24, (0h and EOI), 36, EOT, follow-up 1 and follow-up 2 ]
  • Apparent total body clearance (CL) of BMS-986015 and Ipilimumab [ Time Frame: up to 18 timepoints following each dose during Weeks 1, (0h, EOI and 24h), 2, 3, 4, 10, (0h, EOI and 24h), 11, 13, 24, (0h and EOI), 36, 48, 60, follow-up 1 and follow-up 2 ]
  • Apparent volume of distribution at steady state (Vss) of BMS-986015 and Ipilimumab [ Time Frame: up to 18 timepoints following each dose during Weeks 1, (0h, EOI and 24h), 2, 3, 4, 10, (0h, EOI and 24h), 11, 13, 24, (0h and EOI), 36, 48, 60, follow-up 1 and follow-up 2 ]
  • Serum half-life (T-HALF) of BMS-986015 and Ipilimumab [ Time Frame: up to 18 timepoints following each dose during Weeks 1, (0h, EOI and 24h), 2, 3, 4, 10, (0h, EOI and 24h), 11, 13, 24, (0h and EOI), 36, 48, 60, follow-up 1 and follow-up 2 ]
  • Trough observed serum concentration (Cmin) of BMS-986015 and Ipilimumab [ Time Frame: up to 18 timepoints following each dose during Weeks 1, (0h, EOI and 24h), 2, 3, 4, 10, (0h, EOI and 24h), 11, 13, 24, (0h and EOI), 36, 48, 60, follow-up 1 and follow-up 2 ]
  • Immunogenicity as measured by the incidence of Ipilimumab and anti-Killer cell immunoglobulin-like receptor (KIR) (BMS-986015) anti-drug antibodies (ADA) [ Time Frame: up to 11 timepoints during Weeks 1, 3, 4, 10, 13, 24, 36,48, 60, follow-up 1 and follow-up 2 ]
  • Efficacy as measured by tumor assessment (per RECIST 1.1 and irRECIST 1.1) [ Time Frame: Up to 1.4 years (treatment) and 90 days (follow-up) ]

    Efficacy will be measured based on immune-related Response Evaluation Criteria for Solid Tumors (irRECIST) 1.1 and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using Best overall response (BOR), Objective response rate (ORR), Duration of Response (DOR), Progression-Free Survival Rate (PFSR)

    Efficacy will be measured on every 6-12 weeks while on treatment and approximately every 12 weeks during follow-up

  • The maximum observed serum concentration (Cmax) of BMS-986015 and Ipilimumab [ Time Frame: Up to 17 time points in 18 months ]
  • The time of maximum observed serum concentration (Tmax) of BMS-986015 and Ipilimumab [ Time Frame: Up to 17 time points in 18 months ]
  • Area under the serum concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986015 and Ipilimumab [ Time Frame: Up to 17 time points in 18 months ]
  • Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986015 and Ipilimumab [ Time Frame: Up to 17 time points in 18 months ]
  • Apparent total body clearance (CL) of BMS-986015 and Ipilimumab [ Time Frame: Up to 17 time points in 18 months ]
  • Apparent volume of distribution at steady state (Vss) of BMS-986015 and Ipilimumab [ Time Frame: Up to 17 time points in 18 months ]
  • Serum half-life (T-HALF) of BMS-986015 and Ipilimumab [ Time Frame: Up to 17 time points in 18 months ]
  • Trough observed serum concentration (Cmin) of BMS-986015 and Ipilimumab [ Time Frame: Up to 17 time points in 18 months ]
  • Immunogenicity as measured by the incidence of Ipilimumab and anti-Killer cell immunoglobulin-like receptor (KIR) (BMS-986015) anti-drug antibodies (ADA) [ Time Frame: 9 time points in 18 months ]
  • Immunohistochemistry on mandatory tumor biopsies based on measures of Tumor infiltrating lymphocyte (TIL) [ Time Frame: Baseline (Day 1) and at week 12 (Induction therapy) ]
  • Immunohistochemistry on mandatory tumor biopsies based on Programmed Death Ligand 1 (PD-L1) [ Time Frame: Baseline (Day 1) and at week 12 (Induction therapy) ]
  • Immunohistochemistry on mandatory tumor biopsies based on Human leukocyte antigen (HLA) Class I expression [ Time Frame: Baseline (Day 1) and at week 12 (Induction therapy) ]
Not Provided
Not Provided
 
Safety Study of BMS-986015 (Anti-KIR) in Combination With Ipilimumab in Subjects With Selected Advanced Tumor
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
CANCER, NOS
  • Drug: Lirilumab
    Other Names:
    • BMS-986015
    • IPH-2102
    • ANTI-KIR
  • Drug: Ipilimumab
    Other Name: BMS-734016
Experimental: Arm 1: Lirilumab + Ipilimumab
Lirilumab and Ipilimumab on specific days
Interventions:
  • Drug: Lirilumab
  • Drug: Ipilimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
April 2015
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01750580
CA223-002
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP