Advanced TumorsPhase 1/2BETNCT02419417

Study of BMS-986158 in Subjects With Select Advanced Cancers

A Phase 1/2 study testing BMS-986158 and Nivolumab in people with Advanced Tumors, run by Bristol-Myers Squibb at 13 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986158 in subjects with select advanced cancers Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Advanced Tumors
What is being tested?: BMS-986158 and Nivolumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 83 participants
Where: 13 sitesin 5 countries
Study dates: 19 Jun 2015to 17 Mar 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Must have select advanced cancers with specific genetic profiles
Must have received appropriate standard of care
At least one measurable lesion at baseline
Expected to have life expectancy of at least 3 months
Eastern Cooperative Oncology Group (ECOG) of 0 to 1

Who cannot join

Concomitant second malignancies
Uncontrolled or significant cardiovascular disease
Inadequate bone marrow function
Chronic gastrointestinal illness
Prior treatment with Bromodomain and Extra-Terminal (BET) inhibitor
Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

13 sites in 5 countries.

Country

City, postcode or hospital

13 sites in 5 countries

United States6 sites

University Of Colorado
Aurora, Colorado, 80045
Dana Farber Cancer Institute.
Boston, Massachusetts, 02215
City Of Hope National Medical Center
Duarte, California, 91010
Institute for Translational Oncology Research-ITOR
Greenville, South Carolina, 29605
Univ. Of Pa
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239

Other trials in United States

Spain3 sites

H. Univ. Vall dHebron
Barcelona, 08035
Centro Integral Oncologico Clara Campal
Madrid, 28050
Clinica Universidad de Navarra
Pamplona, 31008

Other trials in Spain

France2 sites

Local Institution
Lyon, 69373
Local Institution
Villejuif, 94800

Other trials in France

Australia1 site

Nucleus Network
Melbourne, Victoria, 3004

Other trials in Australia

Canada1 site

The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6

Other trials in Canada

About this study

Official title: A Phase I/IIa Trial With BMS-986158, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, as Monotherapy or in Combination With Nivolumab in Subjects With Selected Advanced Solid Tumors or Hematologic Malignancies

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986158 in subjects with select advanced cancers

Conditions: Advanced Tumors
Being tested: BMS-986158, Nivolumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BMS-986158Drug
Specified dose on specified days
NivolumabBiological
Also called BMS-936558, Opdivo
Specified dose on specified days

Study groups in NCT02419417
Study group	Role	What they receive
Monotherapy Treatment	Experimental	Patients treated at various doses and schedules Receives: Drug: BMS-986158
Combination Therapy	Experimental	Patients treated at selected doses and schdules Receives: Drug: BMS-986158; Biological: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Experiencing Adverse Events
Number of participants experiencing different types of events, including Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation and deaths.
Events are classified based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Measured: From first dose to 30 days following last dose (up to approximately 29 months)
Number of Participants With Abnormal Hepatic Test Values
Number of participants experiencing abnormal hepatic function, as measured by different parameters.
ALT = Alanine aminotransferase AST = Aspartate aminotransferase ULN = Upper Limit of Normal
Measured: From first dose to 30 days following last dose (up to approximately 29 months)

Secondary outcomes (26)

Best Overall Response (BOR)
BOR, as assessed by the investigator, is defined as the best response designation, recorded between the dates of first dose and the date of first objectively documented progression (per RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies or PCWG3 for prostate cancer) or the date of subsequent therapy, whichever occurs first.
Measured: From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR)
Measured: From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)
Duration of Response (DOR)
DOR is defined as the time between the date of first response and the date of the first objectively documented disease progression (as determined by RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies, or PCWG3 (including PSA assessments) for prostate cancer [CRPC or NEPC]), or death due to any cause, whichever occurs first.
Measured: From date of first response to date of first objectively documented disease progression or death (up to approximately 42 weeks)
Progression Free Survival (PFS)
PFS is defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause.
Measured: From first dose to date of first objectively documented disease progression or death (up to approximately 28 months)
Progression Free Survival Rate (PFSR)
PFSR is defined as the percentage of participants who remain progression free and surviving at the specified timepoints (12 weeks, 24 weeks, and 48 weeks).
Reported values are estimates derived from Kaplan-Meier analyses
Measured: From first dose to 12 weeks, to 24 weeks, and to 48 weeks after first dose
Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
Measured: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
Measured: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
Measured: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
Measured: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
Measured: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Apparent Total Body Clearance (CLT/F) - Single Dose Administration
Values are reported only for the parent BMS-986158
Measured: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Apparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration
Values are reported only for the parent BMS-986158
Measured: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Maximum Observed Plasma Concentration (Cmax) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Measured: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Time to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Measured: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Measured: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Measured: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Minimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are reported only for the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Measured: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Concentration at the End of Dosing Interval (C24) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Measured: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Trough Observed Plasma Concentration (Ctrough) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for the first and last collection
Measured: From Cycle (C)2 Day (D)2 to C2D5 (Schedule A) or from C2D14 to C4D8 (Schedule B) or from C2D7 to C8D8 (Schedule C)
Accumulation Index (AI) - Multiple Dose Administration
AI is defined as the ratio of an exposure measure at steady-state to that after the first dose. Reported exposure measures include Cmax, C24 and AUC24.
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Measured: Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)
Effective Elimination Half-Life (Effective T-HALF) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Measured: Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)
Ratio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose Administration
Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Measured: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose Administration
Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Measured: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration
Measured: Cycle 1 Day 1
Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose Administration
Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Measured: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Change From Baseline in Electrocardiogram Parameter QTcF
QT Interval corrected for Fridericia's Formula. Change from baseline is calculated from pre-dose at the indicated timepoints.
Measured: From Cycle 1 Day 1 to last dosing day in Cycle 2 (C2D8 for Schedule A, C2D14 for Schedule B, C2D7 for Schedule C).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jun 201517 Mar 2021

First posted17 Apr 2015 (estimated)
Study start19 Jun 2015
Primary completion17 Mar 2021
Study completion17 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Advanced TumorsStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02419417
Sponsor's protocol ID: CA011-001
Other IDs: 2015-000324-29, 2015
Acronym: BET
Status last verified: May 2022
First submitted: 2 Apr 2015
Last updated: 16 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/IIa Trial With BMS-986158, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, as Monotherapy or in Combination With Nivolumab in Subjects With Selected Advanced Solid Tumors or Hematologic Malignancies
ClinicalTrials.gov ID: NCT02419417
Acronym / sponsor ID: BET / CA011-001
Conditions: Advanced Tumors
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 19 Jun 2015 (actual)
Primary completion: 17 Mar 2021 (actual)
Study completion: 17 Mar 2021 (actual)
First posted: 17 Apr 2015 (estimated)
Results: Posted 16 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986158 in subjects with select advanced cancers

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Monotherapy Treatment	Experimental	Drug: BMS-986158Patients treated at various doses and schedules
Combination Therapy	Experimental	Drug: BMS-986158, Biological: NivolumabPatients treated at selected doses and schdules

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Must have select advanced cancers with specific genetic profiles
Must have received appropriate standard of care
At least one measurable lesion at baseline
Expected to have life expectancy of at least 3 months
Eastern Cooperative Oncology Group (ECOG) of 0 to 1

Key exclusion criteria (6 listed)

Concomitant second malignancies
Uncontrolled or significant cardiovascular disease
Inadequate bone marrow function
Chronic gastrointestinal illness
Prior treatment with Bromodomain and Extra-Terminal (BET) inhibitor

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BMS-986158Specified dose on specified days	Drug	Combination Therapy, Monotherapy Treatment
NivolumabAlso: BMS-936558, OpdivoSpecified dose on specified days	Biological	Combination Therapy

Primary outcome

Number of Participants Experiencing Adverse Events
Time frame: From first dose to 30 days following last dose (up to approximately 29 months)
Number of participants experiencing different types of events, including Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation and deaths. Events are classified based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Number of Participants With Abnormal Hepatic Test Values
Time frame: From first dose to 30 days following last dose (up to approximately 29 months)
Number of participants experiencing abnormal hepatic function, as measured by different parameters. ALT = Alanine aminotransferase AST = Aspartate aminotransferase ULN = Upper Limit of Normal

26 secondary outcomes

Best Overall Response (BOR)
Time frame: From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)
Objective Response Rate (ORR)
Time frame: From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)
Duration of Response (DOR)
Time frame: From date of first response to date of first objectively documented disease progression or death (up to approximately 42 weeks)
Progression Free Survival (PFS)
Time frame: From first dose to date of first objectively documented disease progression or death (up to approximately 28 months)
Progression Free Survival Rate (PFSR)
Time frame: From first dose to 12 weeks, to 24 weeks, and to 48 weeks after first dose
Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration
Time frame: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration
Time frame: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration
Time frame: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration
Time frame: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose Administration
Time frame: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Apparent Total Body Clearance (CLT/F) - Single Dose Administration
Time frame: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Apparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration
Time frame: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Maximum Observed Plasma Concentration (Cmax) - Multiple Dose Administration
Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Time to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose Administration
Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose Administration
Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose Administration
Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Minimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose Administration
Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Concentration at the End of Dosing Interval (C24) - Multiple Dose Administration
Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Trough Observed Plasma Concentration (Ctrough) - Multiple Dose Administration
Time frame: From Cycle (C)2 Day (D)2 to C2D5 (Schedule A) or from C2D14 to C4D8 (Schedule B) or from C2D7 to C8D8 (Schedule C)
Accumulation Index (AI) - Multiple Dose Administration
Time frame: Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)
Effective Elimination Half-Life (Effective T-HALF) - Multiple Dose Administration
Time frame: Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)
Ratio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose Administration
Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose Administration
Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration
Time frame: Cycle 1 Day 1
Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose Administration
Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Change From Baseline in Electrocardiogram Parameter QTcF
Time frame: From Cycle 1 Day 1 to last dosing day in Cycle 2 (C2D8 for Schedule A, C2D14 for Schedule B, C2D7 for Schedule C).

Results and safety

Results posted to the registry on 16 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1 Schedule A - BMS-986158 0.75 mg	5	0
Part 1 Schedule A - BMS-986158 1.25 mg	4	0
Part 1 Schedule A - BMS-986158 2 mg	13	0
Part 1 Schedule A - BMS-986158 3 mg	10	0
Part 1 Schedule A - BMS-986158 4.5 mg	13	0
Part 1 Schedule B - BMS-986158 2 mg	4	0
Part 1 Schedule B - BMS-986158 3 mg	4	0
Part 1 Schedule C - BMS-986158 2 mg	6	0
Part 1 Schedule C - BMS-986158 3 mg	13	0
Part 1 Schedule C - BMS-986158 4.5 mg	10	0
Part 2 Schedule A	1	0

Primary outcome: Number of Participants Experiencing Adverse Events

Time frame: From first dose to 30 days following last dose (up to approximately 29 months). Count of participants. Unit: Participants

Measure	Part 1 Schedule A - BMS-986158 0.75 mg n = 5	Part 1 Schedule A - BMS-986158 1.25 mg n = 4	Part 1 Schedule A - BMS-986158 2 mg n = 13	Part 1 Schedule A - BMS-986158 3 mg n = 10	Part 1 Schedule A - BMS-986158 4.5 mg n = 13	Part 1 Schedule B - BMS-986158 2 mg n = 4	Part 1 Schedule B - BMS-986158 3 mg n = 4	Part 1 Schedule C - BMS-986158 2 mg n = 6	Part 1 Schedule C - BMS-986158 3 mg n = 13	Part 1 Schedule C - BMS-986158 4.5 mg n = 10	Part 2 Schedule A n = 1
Adverse Events (AEs)	5	4	13	10	13	4	4	6	13	9	1
Serious Adverse Events (SAEs)	3	3	7	7	9	2	2	4	5	3	0
AEs leading to discontinuation	0	0	0	1	3	1	0	1	0	0	0
Deaths	0	1	2	4	3	0	0	1	2	0	0

Population analysed: All treated participants

Primary outcome: Number of Participants With Abnormal Hepatic Test Values

Time frame: From first dose to 30 days following last dose (up to approximately 29 months). Count of participants. Unit: Participants

Measure	Part 1 Schedule A - BMS-986158 0.75 mg n = 5	Part 1 Schedule A - BMS-986158 1.25 mg n = 4	Part 1 Schedule A - BMS-986158 2 mg n = 13	Part 1 Schedule A - BMS-986158 3 mg n = 10	Part 1 Schedule A - BMS-986158 4.5 mg n = 13	Part 1 Schedule B - BMS-986158 2 mg n = 4	Part 1 Schedule B - BMS-986158 3 mg n = 4	Part 1 Schedule C - BMS-986158 2 mg n = 6	Part 1 Schedule C - BMS-986158 3 mg n = 13	Part 1 Schedule C - BMS-986158 4.5 mg n = 10	Part 2 Schedule A n = 1
ALT OR AST > 3XULN	2	1	2	2	2	0	1	0	2	2	0
ALT OR AST > 5XULN	1	0	2	1	2	0	0	0	2	1	0
ALT OR AST > 10XULN	0	0	1	1	0	0	0	0	0	0	0
ALT OR AST > 20XULN	0	0	0	0	0	0	0	0	0	0	0
TOTAL BILIRUBIN > 2XULN	1	0	0	1	4	0	1	0	0	1	1
CONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 1 DAY	1	0	0	1	0	0	0	0	0	1	0
CONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 30 DAYS

26 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality was assessed from date of first dose to study completion (up to approximately 68 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 29 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1 Schedule A - BMS-986158 0.75 mg	3 of 5 (60%)	5 of 5 (100%)	5 of 5
Part 1 Schedule A - BMS-986158 1.25 mg	3 of 4 (75%)	4 of 4 (100%)	3 of 4
Part 1 Schedule A - BMS-986158 2 mg	7 of 13 (53.8%)	12 of 13 (92.3%)	10 of 13
Part 1 Schedule A - BMS-986158 3 mg	7 of 10 (70%)	10 of 10 (100%)	8 of 10
Part 1 Schedule A - BMS-986158 4.5 mg	9 of 13 (69.2%)	13 of 13 (100%)	12 of 13
Part 1 Schedule B - BMS-986158 2 mg	2 of 4 (50%)	4 of 4 (100%)	3 of 4
Part 1 Schedule B - BMS-986158 3 mg	2 of 4 (50%)	4 of 4 (100%)	3 of 4
Part 1 Schedule C - BMS-986158 2 mg	4 of 6 (66.7%)	6 of 6 (100%)	4 of 6
Part 1 Schedule C - BMS-986158 3 mg	5 of 13 (38.5%)	13 of 13 (100%)	10 of 13
Part 1 Schedule C - BMS-986158 4.5 mg	3 of 10 (30%)	9 of 10 (90%)	7 of 10
Part 2 Schedule A	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
Investigator Inquiry FormLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

13 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BMS-986158 and Nivolumab in people with Advanced Tumors, run by Bristol-Myers Squibb at 13 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Spain, France, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Adverse Events (time frame: From first dose to 30 days following last dose (up to approximately 29 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02419417.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.