NCT03203876

Brief Summary

The purpose of this study is to determine whether lirilumab in combination with nivolumab or in combination with nivolumab and ipilimumab is safe in the treatment of advanced and/or metastatic solid tumors

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2017

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

July 14, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2020

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

3.1 years

First QC Date

June 28, 2017

Last Update Submit

March 9, 2022

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (6)

  • Incidence of dose-limiting toxicity (DLT)

    To assess the safety and tolerability of lirilumab in combination with nivolumab

    Up to two years

  • Incidence of adverse events (AEs)

    To assess the safety and tolerability of lirilumab in combination with nivolumab

    Up to two years

  • Incidence of serious adverse events (SAEs)

    To assess the safety and tolerability of lirilumab in combination with nivolumab

    Up to two years

  • Incidence of death

    To assess the safety and tolerability of lirilumab in combination with nivolumab

    Up to two years

  • Frequency of laboratory test toxicity grade shifting from baseline

    To assess the safety and tolerability of lirilumab in combination with nivolumab

    Up to two years

  • Incidence of AEs leading to discontinuation

    To assess the safety and tolerability of lirilumab in combination with nivolumab

    Up to two years

Secondary Outcomes (31)

  • Incidence of dose-limiting toxicity (DLT)

    Up to two years

  • Incidence of adverse events (AEs)

    Up to two years

  • Incidence of serious adverse events (SAEs)

    Up to two years

  • Incidence of death

    Up to two years

  • Frequency of laboratory test toxicity grade shifting from baseline

    Up to two years

  • +26 more secondary outcomes

Study Arms (2)

Part One Combination Therapy

EXPERIMENTAL

Lirilumab and Nivolumab

Biological: LirilumabBiological: Nivolumab

Part 2 Combination Therapy

EXPERIMENTAL

Lirilumab, Nivolumab and Ipilimumab

Biological: LirilumabBiological: NivolumabBiological: Ipilimumab

Interventions

LirilumabBIOLOGICAL

Specified dose on specified days

Also known as: BMS-986015
Part 2 Combination TherapyPart One Combination Therapy
NivolumabBIOLOGICAL

Specified dose on specified days

Also known as: BMS-936558, Opdivo
Part 2 Combination TherapyPart One Combination Therapy
IpilimumabBIOLOGICAL

Specified dose on specified days

Also known as: BMS-734016, Yervoy
Part 2 Combination Therapy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
  • Participants must have histologic or cytologic confirmation of a solid malignancy that is advanced (metastatic and/or unresectable)
  • Presence of at least 1 lesion with measurable disease as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) criteria for response assessment
  • The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

You may not qualify if:

  • Participants with untreated central nervous system (CNS) metastases
  • Participants with an active, known, or suspected autoimmune disease
  • Uncontrolled or significant cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Institution

Kashiwa-shi, Chiba, 2778577, Japan

Location

Local Institution

Kobe, Hyōgo, 6500017, Japan

Location

Related Links

MeSH Terms

Interventions

lirilumabNivolumabIpilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2017

First Posted

June 29, 2017

Study Start

July 14, 2017

Primary Completion

August 6, 2020

Study Completion

August 6, 2020

Last Updated

March 10, 2022

Record last verified: 2022-03

Locations

JP(2)