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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01750580
First received: December 6, 2012
Last updated: October 13, 2014
Last verified: March 2014

December 6, 2012
October 13, 2014
December 2012
October 2016   (final data collection date for primary outcome measure)
  • 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) ] [ Designated as safety issue: Yes ]
  • Safety as measured by the rate of adverse events, and serious adverse events [ Time Frame: 90 days (follow-up) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01750580 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
  • The time of maximum observed serum concentration (Tmax) of BMS-986015 and Ipilimumab [ Time Frame: Up to 17 time points in 18 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Apparent total body clearance (CL) of BMS-986015 and Ipilimumab [ Time Frame: Up to 17 time points in 18 months ] [ Designated as safety issue: Yes ]
  • Apparent volume of distribution at steady state (Vss) of BMS-986015 and Ipilimumab [ Time Frame: Up to 17 time points in 18 months ] [ Designated as safety issue: Yes ]
  • Serum half-life (T-HALF) of BMS-986015 and Ipilimumab [ Time Frame: Up to 17 time points in 18 months ] [ Designated as safety issue: Yes ]
  • Trough observed serum concentration (Cmin) of BMS-986015 and Ipilimumab [ Time Frame: Up to 17 time points in 18 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Immunohistochemistry on mandatory tumor biopsies based on measures of Tumor infiltrating lymphocyte (TIL) [ Time Frame: Baseline (Day 1) and at week 12 (Induction therapy) ] [ Designated as safety issue: No ]
  • Immunohistochemistry on mandatory tumor biopsies based on Programmed Death Ligand 1 (PD-L1) [ Time Frame: Baseline (Day 1) and at week 12 (Induction therapy) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
Same as current
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 0.1, 0.3, 1 or 3 mg/kg and Ipilimumab 3 or 10 mg/kg Solution by Intravenous every 3 weeks in the induction phase for a total of 4 doses for 23 weeks and in maintenance phase every 12 weeks for an additional 4 doses for 37 weeks

    • Dose Escalation

    Interventions:
    • Drug: Lirilumab
    • Drug: Ipilimumab
  • Experimental: Arm 2: Lirilumab + Ipilimumab

    Lirilumab and Ipilimumab Solution by Intravenous dose selected during dose escalation every 3 weeks in the induction phase for a total of 4 doses for 23 weeks and in maintenance phase every 12 weeks for an additional 4 doses for 37 weeks

    • Cohort Expansion

    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.
 
Recruiting
125
October 2016
October 2016   (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

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
Both
18 Years and older
No
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
United States
 
NCT01750580
CA223-002
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
March 2014

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