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

NCT01750580 | Completed Phase 1

• 1 other identifier: CA223-002
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

CANCER, NOS

Outcome Measures

Primary Outcomes (1)

• Safety as measured by the rate of adverse events, and serious adverse events

  Approximately 510 days

Secondary Outcomes (10)

• Efficacy as measured by tumor assessment

  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

  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

  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

  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

  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

Study Arms (1)

Arm 1: Lirilumab + Ipilimumab

EXPERIMENTAL

Lirilumab and Ipilimumab on specific days

Drug: Lirilumab; Drug: Ipilimumab

Interventions

Lirilumab DRUG

Also known as: BMS-986015, IPH-2102, ANTI-KIR

Arm 1: Lirilumab + Ipilimumab

Ipilimumab DRUG

Also known as: BMS-734016

Arm 1: Lirilumab + Ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (6)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University Of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Memorial Sloan Kettering Cancer Ctr

New York, New York, 10065, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Neoplasms

Interventions

lirilumab; Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 17, 2012
• Study Start: December 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 22, 2015

Record last verified: 2015-07

Locations

US (6)