A Study of an Anti-KIR Antibody Lirilumab in Combination With an Anti-PD1 Antibody Nivolumab and Nivolumab Plus an Anti-CTLA-4 Ipilimumab Antibody in Patients With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT01714739 |
Recruitment Status :
Completed
First Posted : October 26, 2012
Last Update Posted : December 14, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
CANCER,NOS | Drug: Lirilumab Drug: Nivolumab Drug: Ipilimumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 337 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2 Study of the Combination of Lirilumab (Anti-KIR) Plus Nivolumab (Anti-PD-1) or Lirilumab Plus Nivolumab and Ipilimumab in Advanced Refractory Solid Tumors |
Actual Study Start Date : | October 7, 2012 |
Actual Primary Completion Date : | December 13, 2019 |
Actual Study Completion Date : | December 13, 2019 |

Arm | Intervention/treatment |
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Experimental: Part 1
Dose Escalation and Initial Signal Detection in Multiple Solid Tumors - Nivolumab with Lirilumab
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Drug: Lirilumab
Specified dose on specified days.
Other Names:
Drug: Nivolumab Specified dose on specified days.
Other Names:
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Experimental: Part 2 and 3: Cohort Expansion
In platinum-refractory recurrent or metastatic SCCHN - Nivolumab with or without Lirilumab
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Drug: Lirilumab
Specified dose on specified days.
Other Names:
Drug: Nivolumab Specified dose on specified days.
Other Names:
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Experimental: Part 4: Cohort Expansion
Additional Signal Detection in Solid Tumors - Nivolumab with Lirilumab (Study Part 4 Removed; No Subjects Enrolled)
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Drug: Lirilumab
Specified dose on specified days.
Other Names:
Drug: Nivolumab Specified dose on specified days.
Other Names:
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Experimental: Part 5 and 6
Safety Lead-In and Additional Signal Detection in Solid Tumors -- Nivolumab Plus Ipilimumab with Lirilumab (Study Part 6 Removed; No Subjects Enrolled)
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Drug: Lirilumab
Specified dose on specified days.
Other Names:
Drug: Nivolumab Specified dose on specified days.
Other Names:
Drug: Ipilimumab Specified dose on specified days.
Other Names:
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- Safety and tolerability of BMS-986015 given in combination with BMS-936558 or BMS-936558 plus BMS-734016 as measured by incidence of adverse events [ Time Frame: Approximately 3 years ]
- Safety and tolerability of BMS-986015 given in combination with BMS-936558 or BMS-936558 plus BMS-734016 as measured by incidence of clinical laboratory test abnormalities including hematology, serum chemistry, and thyroid panel abnormalities [ Time Frame: Approximately 3 years ]
- Objective response rate (ORR) [ Time Frame: Approximately 3 years ]
- Maximum observed serum concentration (Cmax) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
- Time of maximum observed serum concentration (Tmax) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
- Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
- Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
- Trough observed serum concentration (Ctrough) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
- Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
- Clearance (CL) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
- Volume of distribution at steady state (Vss) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
- Half-life (t1/2) of BMS-986015 derived from serum concentration versus time [ Time Frame: Approximately 27 months ]
- Anti-drug antibody (ADA) response to BMS-986015 in combination with BMS-936558 or BMS-734016 [ Time Frame: Approximately 27 months ]
- Overall survival (OS) [ Time Frame: Approximately 3 years ]
- Progression-Free Survival (PFS) [ Time Frame: Approximately 3 years ]
- Duration of response (DOR) [ Time Frame: Approximately 3 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
- During dose escalation, subjects with advanced solid tumors (except for primary CNS metastases) that have progressed following at least one standard regimen
- During cohort expansion, subjects with various solid tumors that have received at least one and no more than 5 prior treatment regimens
- Subjects must have measurable disease
- Subject must consent to provide previously collected tumor tissue
- Women and men ≥18 years of age with performance status of 0 or 1
- At least 4 weeks since any previous treatment for cancer
Exclusion Criteria:
- Active or chronic autoimmune diseases
- Uncontrolled or significant cardiovascular disease
- Chronic hepatitis (except for subjects with hepatocellular carcinoma)
- Active infection
- Active Central nervous system (CNS) metastases
- Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome((HIV/AIDS)
- Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
Other protocol defined inclusion/exclusion criteria could apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714739

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT01714739 |
Other Study ID Numbers: |
CA223-001 |
First Posted: | October 26, 2012 Key Record Dates |
Last Update Posted: | December 14, 2020 |
Last Verified: | December 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasms Nivolumab Ipilimumab Immunoglobulins Antineoplastic Agents, Immunological |
Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |