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

Conditions

• CANCER,NOS

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lirilumab — DRUG
  Specified dose on specified days.
• Nivolumab — DRUG
  Specified dose on specified days.
• Ipilimumab — DRUG
  Specified dose on specified days.

Study Details

To assess the safety and tolerability and preliminary anti-tumor activity of lirilumab (BMS-986015) given in combination with nivolumab (BMS-936558) and to identify dose limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination. In addition, to assess the combinations of lirilumab and nivolumab or lirilumab and nivolumab plus ipilimumab (BMS-734016) in subjects with advanced (metastatic and/or unresectable) refractory solid tumors.

Key Dates

Start date

Oct 7, 2012

Status verified

Jan 2023

Primary completion

Dec 13, 2019

Completion

Dec 13, 2019

Study Design

Enrollment

337 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1
  Dose Escalation and Initial Signal Detection in Multiple Solid Tumors - Nivolumab with Lirilumab
• Experimental: Part 2 and 3: Cohort Expansion
  In platinum-refractory recurrent or metastatic SCCHN - Nivolumab with or without Lirilumab
• Experimental: Part 4: Cohort Expansion
  Additional Signal Detection in Solid Tumors - Nivolumab with Lirilumab (Study Part 4 Removed; No Subjects Enrolled)
• 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)

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) - Parts 1, 2 and 5 [ Time Frame: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years) ]

Locations (16)

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