Skip to content

An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03446040
Enrollment
92
Registered
2018-02-26
Start date
2018-03-08
Completion date
2024-08-29
Last updated
2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer

Brief summary

The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.

Interventions

Specified dose on specified days

BIOLOGICALBMS-986258

Specified dose on specified days

BIOLOGICALNivolumab

Specified dose on specified days

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Histologic confirmation of one of the 5 tumors \[renal cell carcinoma (RCC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC)\] (metastatic, recurrent, and/or unresectable), with measurable disease per response evaluation criteria in solid tumors v1.1 (RECIST v1.1) * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies * Women must agree to follow specific methods of contraception, if applicable

Exclusion criteria

* Active, known or suspected autoimmune disease * Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy * Other active malignancy requiring concurrent intervention Other protocol-defined inclusion/

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Adverse Events (AEs)From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks)An Adverse Event (AE) is any new untoward medical occurrence or worsening of a preexisting medical condition in a study participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose: * Results in death * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event) * Requires inpatient hospitalization or causes prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect.
Number of Participants Who Died During the StudyFrom first dose until death due to any cause (up to approximately 78 months)The number of participants who died during the study.
Number of Participants With Dose Limiting Toxicities (DLTs)From first dose (Cycle 1 Day 1) until day 28 (Cycle 1 Day 28)Dose-limiting toxicity (DLT) refers to a side effect or adverse reaction caused by a drug that is severe enough to prevent an increase in dose or level of that drug. It is typically identified during clinical trials to determine the highest dose of a drug that can be given safely without causing unacceptable side effects. A participant was considered DLT evaluable if they received 1 dose of BMS-986258 in Part A or 1 dose of BMS-986258 and nivolumab 480mg in Part B and completed the DLT observation period. Participants who withdraw from the study during the 4-week DLT evaluation period for reasons other than a DLT may be replaced with a new participant at the same dose level.

Secondary

MeasureTime frameDescription
Maximum Plasma Concentration (Cmax) of BMS-986258Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)Cmax (Maximum Concentration) is the highest level of a drug in the blood after it has been taken. It shows the peak level of the drug, which helps in understanding how much of the drug is absorbed and how strong its effects might be.
Area Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)AUC (0-T) is the total exposure to the drug over a specific period; from the time you take it until a specified time. It helps in understanding the overall amount of drug that has been in your body over that time period.
Area Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Part A and B: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)AUC(TAU) (Area Under the Curve over the Dosing Interval) is the total exposure to the drug over one complete dosing interval (the time between doses). It helps in understanding how much of the drug is in your body over the entire period between doses, which is important for determining the right dosing schedule.
Objective Response Rate (ORR)From first dose until disease progression or death, whichever occurred first (up to approximately 78 months)Objective response rate (ORR) is defined as the percent of treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time to Reach Maximum Concentration (Tmax) of BMS-986258Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)Tmax (Time to Reach Maximum Concentration) is the time it takes for the drug to reach its highest level in the blood after taking it. It helps in understanding how quickly the drug starts to work and reaches its peak effect.
Number of Participants With Anti-Drug Antibodies to BMS-986258 or NivolumabFrom first dose until 100 days after last dose of study therapy (up to approximately 78 weeks)Baseline ADA-positive participant is defined as a participant who has an ADA-detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment
Concentration at the End of the Dosing Interval (Ctau) of BMS-986258Part A and B: On Cycle 1 Day 29 and Cycle 3 Day 29 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 29 and Cycle 2 Day 1 predose (1 cycle = 8 weeks)Ctau (Concentration at the End of the Dosing Interval) is the level of the drug in the blood just before the next dose is due. It shows how much of the drug remains in your body before taking the next dose, which helps in ensuring that the drug levels stay effective without dropping too low.
Median Duration of Response (mDOR)From first dose until disease progression or death whichever occurred first (up to approximately 78 months)Median duration of response (mDOR) for a participant with a best overall response (BOR) of complete response (CR) or partial response (PR) is defined as the time between the date of first response and the date of the first objectively documented disease progression (DP) per RECIST v1.1 or death, whichever occurred first. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Disease Progression (DP): At least a 20% increase in the sum of the diameters of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions. Based on Kaplan-Meier estimates.
Progression-Free Survival (PFS) Rate at 6, 9, and 12 MonthsAt 6, 9, and 12 months after first doseProgression free survival (PFS) for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurred first. Disease Progression (DP): At least a 20% increase in the sum of the diameters of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.

Countries

Australia, Canada, Japan, United States

Participant flow

Pre-assignment details

Participants were treated in Part A, Part A1, and Part B. No participants were enrolled or treated in Part C. 4 participants in Part A1 transitioned to Part B.

Participants by arm

ArmCount
Part A: BMS-986258 8 mg
Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
3
Part A: BMS-986258 24 mg
Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
3
Part A: BMS-986258 72 mg
Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
4
Part A: BMS-986258 200 mg
Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
4
Part A: BMS-986258 480 mg
Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
4
Part A: BMS-986258 800 mg
Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
9
Part A: BMS-986258 1200 mg
Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
3
Part A: BMS-986258 1600 mg
Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
5
Part A: BMS-986258 2400 mg
Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
8
Part B: BMS-986258 480 mg + NIVO 480 mg
Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
4
Part B: BMS-986258 800 mg + NIVO 480 mg
Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
11
Part B: BMS-986258 1200 mg + NIVO 480 mg
Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
4
Part B: BMS-986258 1600 mg + NIVO 480 mg
Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
15
Part A1: BMS-986258 1200 mg + ENHANZE
Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
15
Total92

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010FG011FG012FG013
Overall StudyAdverse Event00000200100000
Overall StudyDeath00000000001002
Overall StudyDisease progression33344634249377
Overall StudyNot reported00100000000000
Overall StudyParticipant requested to discontinue study treatment00000000000100
Overall StudyParticipant withdrew consent00000101000000
Overall StudyStudy drug toxicity00000000100000

Baseline characteristics

CharacteristicPart A: BMS-986258 8 mgPart A: BMS-986258 24 mgPart A: BMS-986258 72 mgPart A: BMS-986258 200 mgPart A: BMS-986258 480 mgPart A: BMS-986258 800 mgPart A: BMS-986258 1200 mgPart A: BMS-986258 1600 mgPart A: BMS-986258 2400 mgPart B: BMS-986258 480 mg + NIVO 480 mgPart B: BMS-986258 800 mg + NIVO 480 mgPart B: BMS-986258 1200 mg + NIVO 480 mgPart B: BMS-986258 1600 mg + NIVO 480 mgPart A1: BMS-986258 1200 mg + ENHANZETotal
Age, Continuous60.7 Years
STANDARD_DEVIATION 16.17
45.7 Years
STANDARD_DEVIATION 6.03
61.5 Years
STANDARD_DEVIATION 3.11
67.0 Years
STANDARD_DEVIATION 4.24
60 Years
STANDARD_DEVIATION 12.44
61.1 Years
STANDARD_DEVIATION 7.1
65.3 Years
STANDARD_DEVIATION 8.33
54.8 Years
STANDARD_DEVIATION 8.07
58.4 Years
STANDARD_DEVIATION 5.85
64.5 Years
STANDARD_DEVIATION 5.07
62.5 Years
STANDARD_DEVIATION 7.75
57.3 Years
STANDARD_DEVIATION 16.2
58.5 Years
STANDARD_DEVIATION 15
57.8 Years
STANDARD_DEVIATION 12.27
59.6 Years
STANDARD_DEVIATION 10.62
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2 Participants3 Participants4 Participants4 Participants3 Participants8 Participants3 Participants5 Participants8 Participants3 Participants10 Participants4 Participants11 Participants14 Participants82 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants1 Participants0 Participants3 Participants0 Participants6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants1 Participants1 Participants2 Participants1 Participants1 Participants1 Participants3 Participants1 Participants2 Participants2 Participants4 Participants3 Participants22 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants1 Participants0 Participants1 Participants0 Participants2 Participants0 Participants0 Participants0 Participants0 Participants1 Participants2 Participants9 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants2 Participants0 Participants4 Participants
Race (NIH/OMB)
White
2 Participants0 Participants2 Participants2 Participants2 Participants7 Participants2 Participants2 Participants5 Participants3 Participants8 Participants2 Participants8 Participants10 Participants55 Participants
Sex: Female, Male
Female
1 Participants0 Participants4 Participants3 Participants1 Participants4 Participants3 Participants1 Participants2 Participants2 Participants3 Participants2 Participants5 Participants4 Participants35 Participants
Sex: Female, Male
Male
2 Participants3 Participants0 Participants1 Participants3 Participants5 Participants0 Participants4 Participants6 Participants2 Participants8 Participants2 Participants10 Participants11 Participants57 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
EG012
affected / at risk
EG013
affected / at risk
EG014
affected / at risk
EG015
affected / at risk
deaths
Total, all-cause mortality
3 / 33 / 33 / 43 / 43 / 47 / 93 / 34 / 55 / 83 / 49 / 110 / 410 / 157 / 111 / 20 / 2
other
Total, other adverse events
2 / 32 / 34 / 44 / 44 / 48 / 92 / 35 / 58 / 84 / 49 / 114 / 415 / 159 / 112 / 22 / 2
serious
Total, serious adverse events
1 / 32 / 33 / 41 / 40 / 44 / 91 / 33 / 52 / 82 / 46 / 111 / 46 / 153 / 110 / 20 / 2

Outcome results

Primary

Number of Participants Who Died During the Study

The number of participants who died during the study.

Time frame: From first dose until death due to any cause (up to approximately 78 months)

Population: All treated participants. Participants who crossed over from part A1 are accounted for under their original arm assignment.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part A: BMS-986258 8 mgNumber of Participants Who Died During the Study3 Participants
Part A: BMS-986258 24 mgNumber of Participants Who Died During the Study3 Participants
Part A: BMS-986258 72 mgNumber of Participants Who Died During the Study3 Participants
Part A: BMS-986258 200 mgNumber of Participants Who Died During the Study3 Participants
Part A: BMS-986258 480 mgNumber of Participants Who Died During the Study3 Participants
Part A: BMS-986258 800 mgNumber of Participants Who Died During the Study7 Participants
Part A: BMS-986258 1200 mgNumber of Participants Who Died During the Study3 Participants
Part A: BMS-986258 1600 mgNumber of Participants Who Died During the Study4 Participants
Part A: BMS-986258 2400 mgNumber of Participants Who Died During the Study5 Participants
Part B: BMS-986258 480 mg + NIVO 480 mgNumber of Participants Who Died During the Study3 Participants
Part B: BMS-986258 800 mg + NIVO 480 mgNumber of Participants Who Died During the Study9 Participants
Part B: BMS-986258 1200 mg + NIVO 480 mgNumber of Participants Who Died During the Study0 Participants
Part B: BMS-986258 1600 mg + NIVO 480 mgNumber of Participants Who Died During the Study10 Participants
Part A1: BMS-986258 1200 mg + ENHANZENumber of Participants Who Died During the Study8 Participants
Primary

Number of Participants With Adverse Events (AEs)

An Adverse Event (AE) is any new untoward medical occurrence or worsening of a preexisting medical condition in a study participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose: * Results in death * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event) * Requires inpatient hospitalization or causes prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect.

Time frame: From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks)

Population: All treated participants. Participants who started in the Part A1 group but transitioned to Part B are accounted for in both treatment groups.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part A: BMS-986258 8 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs) leading to discontinuation of study treatment0 Participants
Part A: BMS-986258 8 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs)3 Participants
Part A: BMS-986258 8 mgNumber of Participants With Adverse Events (AEs)Serious Adverse Events (SAEs)1 Participants
Part A: BMS-986258 24 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs) leading to discontinuation of study treatment0 Participants
Part A: BMS-986258 24 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs)3 Participants
Part A: BMS-986258 24 mgNumber of Participants With Adverse Events (AEs)Serious Adverse Events (SAEs)2 Participants
Part A: BMS-986258 72 mgNumber of Participants With Adverse Events (AEs)Serious Adverse Events (SAEs)3 Participants
Part A: BMS-986258 72 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs) leading to discontinuation of study treatment1 Participants
Part A: BMS-986258 72 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs)4 Participants
Part A: BMS-986258 200 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs) leading to discontinuation of study treatment1 Participants
Part A: BMS-986258 200 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs)4 Participants
Part A: BMS-986258 200 mgNumber of Participants With Adverse Events (AEs)Serious Adverse Events (SAEs)1 Participants
Part A: BMS-986258 480 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs) leading to discontinuation of study treatment0 Participants
Part A: BMS-986258 480 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs)4 Participants
Part A: BMS-986258 480 mgNumber of Participants With Adverse Events (AEs)Serious Adverse Events (SAEs)0 Participants
Part A: BMS-986258 800 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs) leading to discontinuation of study treatment2 Participants
Part A: BMS-986258 800 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs)8 Participants
Part A: BMS-986258 800 mgNumber of Participants With Adverse Events (AEs)Serious Adverse Events (SAEs)4 Participants
Part A: BMS-986258 1200 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs) leading to discontinuation of study treatment0 Participants
Part A: BMS-986258 1200 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs)2 Participants
Part A: BMS-986258 1200 mgNumber of Participants With Adverse Events (AEs)Serious Adverse Events (SAEs)1 Participants
Part A: BMS-986258 1600 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs) leading to discontinuation of study treatment0 Participants
Part A: BMS-986258 1600 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs)5 Participants
Part A: BMS-986258 1600 mgNumber of Participants With Adverse Events (AEs)Serious Adverse Events (SAEs)3 Participants
Part A: BMS-986258 2400 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs) leading to discontinuation of study treatment0 Participants
Part A: BMS-986258 2400 mgNumber of Participants With Adverse Events (AEs)Serious Adverse Events (SAEs)2 Participants
Part A: BMS-986258 2400 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs)8 Participants
Part B: BMS-986258 480 mg + NIVO 480 mgNumber of Participants With Adverse Events (AEs)Serious Adverse Events (SAEs)2 Participants
Part B: BMS-986258 480 mg + NIVO 480 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs)4 Participants
Part B: BMS-986258 480 mg + NIVO 480 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs) leading to discontinuation of study treatment0 Participants
Part B: BMS-986258 800 mg + NIVO 480 mgNumber of Participants With Adverse Events (AEs)Serious Adverse Events (SAEs)6 Participants
Part B: BMS-986258 800 mg + NIVO 480 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs) leading to discontinuation of study treatment0 Participants
Part B: BMS-986258 800 mg + NIVO 480 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs)11 Participants
Part B: BMS-986258 1200 mg + NIVO 480 mgNumber of Participants With Adverse Events (AEs)Serious Adverse Events (SAEs)1 Participants
Part B: BMS-986258 1200 mg + NIVO 480 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs)6 Participants
Part B: BMS-986258 1200 mg + NIVO 480 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs) leading to discontinuation of study treatment0 Participants
Part B: BMS-986258 1600 mg + NIVO 480 mgNumber of Participants With Adverse Events (AEs)Serious Adverse Events (SAEs)6 Participants
Part B: BMS-986258 1600 mg + NIVO 480 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs) leading to discontinuation of study treatment3 Participants
Part B: BMS-986258 1600 mg + NIVO 480 mgNumber of Participants With Adverse Events (AEs)Adverse Events (AEs)17 Participants
Part A1: BMS-986258 1200 mg + ENHANZENumber of Participants With Adverse Events (AEs)Serious Adverse Events (SAEs)3 Participants
Part A1: BMS-986258 1200 mg + ENHANZENumber of Participants With Adverse Events (AEs)Adverse Events (AEs) leading to discontinuation of study treatment0 Participants
Part A1: BMS-986258 1200 mg + ENHANZENumber of Participants With Adverse Events (AEs)Adverse Events (AEs)13 Participants
Primary

Number of Participants With Dose Limiting Toxicities (DLTs)

Dose-limiting toxicity (DLT) refers to a side effect or adverse reaction caused by a drug that is severe enough to prevent an increase in dose or level of that drug. It is typically identified during clinical trials to determine the highest dose of a drug that can be given safely without causing unacceptable side effects. A participant was considered DLT evaluable if they received 1 dose of BMS-986258 in Part A or 1 dose of BMS-986258 and nivolumab 480mg in Part B and completed the DLT observation period. Participants who withdraw from the study during the 4-week DLT evaluation period for reasons other than a DLT may be replaced with a new participant at the same dose level.

Time frame: From first dose (Cycle 1 Day 1) until day 28 (Cycle 1 Day 28)

Population: All treated participants who were evaluable for DLTs.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part A: BMS-986258 8 mgNumber of Participants With Dose Limiting Toxicities (DLTs)0 Participants
Part A: BMS-986258 24 mgNumber of Participants With Dose Limiting Toxicities (DLTs)0 Participants
Part A: BMS-986258 72 mgNumber of Participants With Dose Limiting Toxicities (DLTs)0 Participants
Part A: BMS-986258 200 mgNumber of Participants With Dose Limiting Toxicities (DLTs)0 Participants
Part A: BMS-986258 480 mgNumber of Participants With Dose Limiting Toxicities (DLTs)0 Participants
Part A: BMS-986258 800 mgNumber of Participants With Dose Limiting Toxicities (DLTs)0 Participants
Part A: BMS-986258 1200 mgNumber of Participants With Dose Limiting Toxicities (DLTs)0 Participants
Part A: BMS-986258 1600 mgNumber of Participants With Dose Limiting Toxicities (DLTs)0 Participants
Part A: BMS-986258 2400 mgNumber of Participants With Dose Limiting Toxicities (DLTs)0 Participants
Part B: BMS-986258 480 mg + NIVO 480 mgNumber of Participants With Dose Limiting Toxicities (DLTs)0 Participants
Part B: BMS-986258 800 mg + NIVO 480 mgNumber of Participants With Dose Limiting Toxicities (DLTs)0 Participants
Part B: BMS-986258 1200 mg + NIVO 480 mgNumber of Participants With Dose Limiting Toxicities (DLTs)0 Participants
Part B: BMS-986258 1600 mg + NIVO 480 mgNumber of Participants With Dose Limiting Toxicities (DLTs)0 Participants
Part A1: BMS-986258 1200 mg + ENHANZENumber of Participants With Dose Limiting Toxicities (DLTs)0 Participants
Secondary

Area Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258

AUC (0-T) is the total exposure to the drug over a specific period; from the time you take it until a specified time. It helps in understanding the overall amount of drug that has been in your body over that time period.

Time frame: Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)

Population: All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part A: BMS-986258 8 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 1 Day 153.7 h*ug/mLGeometric Coefficient of Variation 50.8
Part A: BMS-986258 24 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 1 Day 1457 h*ug/mLGeometric Coefficient of Variation 56
Part A: BMS-986258 24 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 3 Day 11400 h*ug/mL
Part A: BMS-986258 72 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 1 Day 14690 h*ug/mLGeometric Coefficient of Variation 43.3
Part A: BMS-986258 200 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 1 Day 18180 h*ug/mLGeometric Coefficient of Variation 101
Part A: BMS-986258 200 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 3 Day 113400 h*ug/mL
Part A: BMS-986258 480 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 1 Day 126100 h*ug/mLGeometric Coefficient of Variation 46.7
Part A: BMS-986258 800 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 3 Day 1102000 h*ug/mL
Part A: BMS-986258 800 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 1 Day 146000 h*ug/mLGeometric Coefficient of Variation 83.9
Part A: BMS-986258 1200 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 1 Day 197000 h*ug/mLGeometric Coefficient of Variation 23.3
Part A: BMS-986258 1600 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 1 Day 175300 h*ug/mLGeometric Coefficient of Variation 44.5
Part A: BMS-986258 2400 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 1 Day 1179000 h*ug/mLGeometric Coefficient of Variation 24.3
Part A: BMS-986258 2400 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 3 Day 1135000 h*ug/mL
Part B: BMS-986258 480 mg + NIVO 480 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 1 Day 129000 h*ug/mLGeometric Coefficient of Variation 51.4
Part B: BMS-986258 480 mg + NIVO 480 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 3 Day 129800 h*ug/mL
Part B: BMS-986258 800 mg + NIVO 480 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 3 Day 138200 h*ug/mL
Part B: BMS-986258 800 mg + NIVO 480 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 1 Day 144300 h*ug/mLGeometric Coefficient of Variation 34.9
Part B: BMS-986258 1200 mg + NIVO 480 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 1 Day 184100 h*ug/mLGeometric Coefficient of Variation 83.2
Part B: BMS-986258 1200 mg + NIVO 480 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 3 Day 189000 h*ug/mL
Part B: BMS-986258 1600 mg + NIVO 480 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 1 Day 1118000 h*ug/mLGeometric Coefficient of Variation 25.4
Part B: BMS-986258 1600 mg + NIVO 480 mgArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 3 Day 1171000 h*ug/mLGeometric Coefficient of Variation 27
Part A1: BMS-986258 1200 mg + ENHANZEArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 1 Day 148500 h*ug/mLGeometric Coefficient of Variation 51.1
Part A1: BMS-986258 1200 mg + ENHANZEArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258Cycle 1 Day 29138000 h*ug/mLGeometric Coefficient of Variation 21
Secondary

Area Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258

AUC(TAU) (Area Under the Curve over the Dosing Interval) is the total exposure to the drug over one complete dosing interval (the time between doses). It helps in understanding how much of the drug is in your body over the entire period between doses, which is important for determining the right dosing schedule.

Time frame: Part A and B: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)

Population: All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part A: BMS-986258 24 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 1 Day 1587 h*ug/mLGeometric Coefficient of Variation 41.9
Part A: BMS-986258 24 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 3 Day 11440 h*ug/mL
Part A: BMS-986258 72 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 1 Day 14870 h*ug/mLGeometric Coefficient of Variation 43.7
Part A: BMS-986258 200 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 3 Day 113400 h*ug/mL
Part A: BMS-986258 200 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 1 Day 18400 h*ug/mLGeometric Coefficient of Variation 105
Part A: BMS-986258 480 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 1 Day 126900 h*ug/mLGeometric Coefficient of Variation 47.4
Part A: BMS-986258 800 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 1 Day 156400 h*ug/mLGeometric Coefficient of Variation 45
Part A: BMS-986258 800 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 3 Day 1102000 h*ug/mL
Part A: BMS-986258 1200 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 1 Day 1100000 h*ug/mLGeometric Coefficient of Variation 18
Part A: BMS-986258 1600 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 1 Day 185800 h*ug/mLGeometric Coefficient of Variation 21.9
Part A: BMS-986258 2400 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 1 Day 1187000 h*ug/mLGeometric Coefficient of Variation 29.5
Part A: BMS-986258 2400 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 3 Day 1135000 h*ug/mL
Part B: BMS-986258 480 mg + NIVO 480 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 1 Day 129000 h*ug/mLGeometric Coefficient of Variation 51.4
Part B: BMS-986258 480 mg + NIVO 480 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 3 Day 118600 h*ug/mL
Part B: BMS-986258 800 mg + NIVO 480 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 1 Day 147300 h*ug/mLGeometric Coefficient of Variation 29.4
Part B: BMS-986258 800 mg + NIVO 480 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 3 Day 138200 h*ug/mL
Part B: BMS-986258 1200 mg + NIVO 480 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 1 Day 189600 h*ug/mLGeometric Coefficient of Variation 67.9
Part B: BMS-986258 1200 mg + NIVO 480 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 3 Day 189000 h*ug/mL
Part B: BMS-986258 1600 mg + NIVO 480 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 3 Day 1172000 h*ug/mLGeometric Coefficient of Variation 26.1
Part B: BMS-986258 1600 mg + NIVO 480 mgArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 1 Day 1120000 h*ug/mLGeometric Coefficient of Variation 22.5
Part A1: BMS-986258 1200 mg + ENHANZEArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 1 Day 29134000 h*ug/mLGeometric Coefficient of Variation 17.3
Part A1: BMS-986258 1200 mg + ENHANZEArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258Cycle 1 Day 146200 h*ug/mLGeometric Coefficient of Variation 53.9
Secondary

Concentration at the End of the Dosing Interval (Ctau) of BMS-986258

Ctau (Concentration at the End of the Dosing Interval) is the level of the drug in the blood just before the next dose is due. It shows how much of the drug remains in your body before taking the next dose, which helps in ensuring that the drug levels stay effective without dropping too low.

Time frame: Part A and B: On Cycle 1 Day 29 and Cycle 3 Day 29 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 29 and Cycle 2 Day 1 predose (1 cycle = 8 weeks)

Population: All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part A: BMS-986258 24 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 3 Day 29 predose0.0711 ug/mL
Part A: BMS-986258 24 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 1 Day 29 predose0.0245 ug/mLGeometric Coefficient of Variation 52.3
Part A: BMS-986258 72 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 1 Day 29 predose1.58 ug/mLGeometric Coefficient of Variation 116
Part A: BMS-986258 200 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 1 Day 29 predose2.59 ug/mLGeometric Coefficient of Variation 369
Part A: BMS-986258 200 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 3 Day 29 predose8.32 ug/mL
Part A: BMS-986258 480 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 1 Day 29 predose15.5 ug/mLGeometric Coefficient of Variation 68.6
Part A: BMS-986258 800 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 1 Day 29 predose37.2 ug/mLGeometric Coefficient of Variation 62.9
Part A: BMS-986258 800 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 3 Day 29 predose80.3 ug/mL
Part A: BMS-986258 1200 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 1 Day 29 predose55.7 ug/mLGeometric Coefficient of Variation 55.2
Part A: BMS-986258 1600 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 1 Day 29 predose36.9 ug/mLGeometric Coefficient of Variation 68.5
Part A: BMS-986258 2400 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 1 Day 29 predose109 ug/mLGeometric Coefficient of Variation 44.6
Part A: BMS-986258 2400 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 3 Day 29 predose71.3 ug/mL
Part B: BMS-986258 480 mg + NIVO 480 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 1 Day 29 predose15.6 ug/mLGeometric Coefficient of Variation 82.3
Part B: BMS-986258 480 mg + NIVO 480 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 3 Day 29 predose7.77 ug/mL
Part B: BMS-986258 800 mg + NIVO 480 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 3 Day 29 predose25 ug/mL
Part B: BMS-986258 800 mg + NIVO 480 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 1 Day 29 predose23.5 ug/mLGeometric Coefficient of Variation 70.3
Part B: BMS-986258 1200 mg + NIVO 480 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 1 Day 29 predose39.8 ug/mLGeometric Coefficient of Variation 229
Part B: BMS-986258 1200 mg + NIVO 480 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 3 Day 29 predose37.1 ug/mL
Part B: BMS-986258 1600 mg + NIVO 480 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 1 Day 29 predose68.4 ug/mLGeometric Coefficient of Variation 47.1
Part B: BMS-986258 1600 mg + NIVO 480 mgConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 3 Day 29 predose121 ug/mLGeometric Coefficient of Variation 36.6
Part A1: BMS-986258 1200 mg + ENHANZEConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 1 Day 29 predose37.7 ug/mLGeometric Coefficient of Variation 80.2
Part A1: BMS-986258 1200 mg + ENHANZEConcentration at the End of the Dosing Interval (Ctau) of BMS-986258Cycle 2 Day 1 predose114 ug/mLGeometric Coefficient of Variation 13
Secondary

Maximum Plasma Concentration (Cmax) of BMS-986258

Cmax (Maximum Concentration) is the highest level of a drug in the blood after it has been taken. It shows the peak level of the drug, which helps in understanding how much of the drug is absorbed and how strong its effects might be.

Time frame: Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)

Population: All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part A: BMS-986258 8 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 1 Day 12.27 ug/mLGeometric Coefficient of Variation 53.8
Part A: BMS-986258 24 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 3 Day 19.26 ug/mL
Part A: BMS-986258 24 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 1 Day 15.34 ug/mLGeometric Coefficient of Variation 36.2
Part A: BMS-986258 72 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 1 Day 131.5 ug/mLGeometric Coefficient of Variation 10.9
Part A: BMS-986258 200 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 3 Day 150 ug/mL
Part A: BMS-986258 200 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 1 Day 147.2 ug/mLGeometric Coefficient of Variation 120
Part A: BMS-986258 480 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 1 Day 1121 ug/mLGeometric Coefficient of Variation 30.7
Part A: BMS-986258 800 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 3 Day 1356 ug/mL
Part A: BMS-986258 800 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 1 Day 1239 ug/mLGeometric Coefficient of Variation 35.6
Part A: BMS-986258 1200 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 1 Day 1423 ug/mLGeometric Coefficient of Variation 12.9
Part A: BMS-986258 1600 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 1 Day 1412 ug/mLGeometric Coefficient of Variation 26.7
Part A: BMS-986258 2400 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 3 Day 1605 ug/mL
Part A: BMS-986258 2400 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 1 Day 1890 ug/mLGeometric Coefficient of Variation 29.2
Part B: BMS-986258 480 mg + NIVO 480 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 3 Day 1111 ug/mL
Part B: BMS-986258 480 mg + NIVO 480 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 1 Day 1154 ug/mLGeometric Coefficient of Variation 43.4
Part B: BMS-986258 800 mg + NIVO 480 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 1 Day 1244 ug/mLGeometric Coefficient of Variation 24.8
Part B: BMS-986258 800 mg + NIVO 480 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 3 Day 1161 ug/mL
Part B: BMS-986258 1200 mg + NIVO 480 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 3 Day 1422 ug/mL
Part B: BMS-986258 1200 mg + NIVO 480 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 1 Day 1449 ug/mLGeometric Coefficient of Variation 31.5
Part B: BMS-986258 1600 mg + NIVO 480 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 1 Day 1579 ug/mLGeometric Coefficient of Variation 19.4
Part B: BMS-986258 1600 mg + NIVO 480 mgMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 3 Day 1684 ug/mLGeometric Coefficient of Variation 18.1
Part A1: BMS-986258 1200 mg + ENHANZEMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 1 Day 29479 ug/mLGeometric Coefficient of Variation 21.2
Part A1: BMS-986258 1200 mg + ENHANZEMaximum Plasma Concentration (Cmax) of BMS-986258Cycle 1 Day 1121 ug/mLGeometric Coefficient of Variation 44.1
Secondary

Median Duration of Response (mDOR)

Median duration of response (mDOR) for a participant with a best overall response (BOR) of complete response (CR) or partial response (PR) is defined as the time between the date of first response and the date of the first objectively documented disease progression (DP) per RECIST v1.1 or death, whichever occurred first. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Disease Progression (DP): At least a 20% increase in the sum of the diameters of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions. Based on Kaplan-Meier estimates.

Time frame: From first dose until disease progression or death whichever occurred first (up to approximately 78 months)

Population: All treated participants witha complete or partial response. Prespecified to be reported collectively per Part. Response evaluable participants who crossed over from part A1 to Part B are accounted for in both arms.

ArmMeasureValue (MEDIAN)
Part A: BMS-986258 24 mgMedian Duration of Response (mDOR)NA Months
Secondary

Number of Participants With Anti-Drug Antibodies to BMS-986258 or Nivolumab

Baseline ADA-positive participant is defined as a participant who has an ADA-detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment

Time frame: From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks)

Population: All treated participants with baseline and at least one post-baseline pre-infusion ADA assessment. Prespecified to be reported collectively per Part. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part A: BMS-986258 8 mgNumber of Participants With Anti-Drug Antibodies to BMS-986258 or NivolumabBaseline ADA positive: BMS-9862580 Participants
Part A: BMS-986258 8 mgNumber of Participants With Anti-Drug Antibodies to BMS-986258 or NivolumabADA positive: BMS-9862582 Participants
Part A: BMS-986258 24 mgNumber of Participants With Anti-Drug Antibodies to BMS-986258 or NivolumabADA positive: BMS-9862580 Participants
Part A: BMS-986258 24 mgNumber of Participants With Anti-Drug Antibodies to BMS-986258 or NivolumabBaseline ADA positive: BMS-9862580 Participants
Part A: BMS-986258 24 mgNumber of Participants With Anti-Drug Antibodies to BMS-986258 or NivolumabBaseline ADA positive: nivolumab1 Participants
Part A: BMS-986258 24 mgNumber of Participants With Anti-Drug Antibodies to BMS-986258 or NivolumabADA positive: nivolumab2 Participants
Part A: BMS-986258 72 mgNumber of Participants With Anti-Drug Antibodies to BMS-986258 or NivolumabADA positive: nivolumab0 Participants
Part A: BMS-986258 72 mgNumber of Participants With Anti-Drug Antibodies to BMS-986258 or NivolumabBaseline ADA positive: nivolumab0 Participants
Part A: BMS-986258 72 mgNumber of Participants With Anti-Drug Antibodies to BMS-986258 or NivolumabBaseline ADA positive: BMS-9862580 Participants
Part A: BMS-986258 72 mgNumber of Participants With Anti-Drug Antibodies to BMS-986258 or NivolumabADA positive: BMS-9862580 Participants
Secondary

Objective Response Rate (ORR)

Objective response rate (ORR) is defined as the percent of treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Time frame: From first dose until disease progression or death, whichever occurred first (up to approximately 78 months)

Population: All treated participants. Prespecified to be reported collectively per Part. Participants who crossed over from part A1 to Part B are accounted for in both arms.

ArmMeasureValue (NUMBER)
Part A: BMS-986258 8 mgObjective Response Rate (ORR)0 Percent of Participants
Part A: BMS-986258 24 mgObjective Response Rate (ORR)5.4 Percent of Participants
Part A: BMS-986258 72 mgObjective Response Rate (ORR)0 Percent of Participants
Secondary

Progression-Free Survival (PFS) Rate at 6, 9, and 12 Months

Progression free survival (PFS) for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurred first. Disease Progression (DP): At least a 20% increase in the sum of the diameters of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.

Time frame: At 6, 9, and 12 months after first dose

Population: All treated participants. Prespecified to be reported collectively per Part. Treated participants who crossed over from part A1 to Part B are accounted for in both arms.

ArmMeasureGroupValue (NUMBER)
Part A: BMS-986258 8 mgProgression-Free Survival (PFS) Rate at 6, 9, and 12 Months12-month17.1 Percent of Participants
Part A: BMS-986258 8 mgProgression-Free Survival (PFS) Rate at 6, 9, and 12 Months9-month17.1 Percent of Participants
Part A: BMS-986258 8 mgProgression-Free Survival (PFS) Rate at 6, 9, and 12 Months6-month21.4 Percent of Participants
Part A: BMS-986258 24 mgProgression-Free Survival (PFS) Rate at 6, 9, and 12 Months6-month21.9 Percent of Participants
Part A: BMS-986258 24 mgProgression-Free Survival (PFS) Rate at 6, 9, and 12 Months9-month8.2 Percent of Participants
Part A: BMS-986258 24 mgProgression-Free Survival (PFS) Rate at 6, 9, and 12 Months12-month0.0 Percent of Participants
Part A: BMS-986258 72 mgProgression-Free Survival (PFS) Rate at 6, 9, and 12 Months6-month8.7 Percent of Participants
Part A: BMS-986258 72 mgProgression-Free Survival (PFS) Rate at 6, 9, and 12 Months12-month0.0 Percent of Participants
Part A: BMS-986258 72 mgProgression-Free Survival (PFS) Rate at 6, 9, and 12 Months9-month8.7 Percent of Participants
Secondary

Time to Reach Maximum Concentration (Tmax) of BMS-986258

Tmax (Time to Reach Maximum Concentration) is the time it takes for the drug to reach its highest level in the blood after taking it. It helps in understanding how quickly the drug starts to work and reaches its peak effect.

Time frame: Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)

Population: All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Part A: BMS-986258 8 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 1 Day 10.808 Hours
Part A: BMS-986258 24 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 1 Day 11.23 Hours
Part A: BMS-986258 24 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 3 Day 14 Hours
Part A: BMS-986258 72 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 1 Day 11.4 Hours
Part A: BMS-986258 200 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 3 Day 10.7 Hours
Part A: BMS-986258 200 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 1 Day 12.11 Hours
Part A: BMS-986258 480 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 1 Day 13.92 Hours
Part A: BMS-986258 800 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 1 Day 10.998 Hours
Part A: BMS-986258 800 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 3 Day 14.27 Hours
Part A: BMS-986258 1200 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 1 Day 11.09 Hours
Part A: BMS-986258 1600 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 1 Day 11.47 Hours
Part A: BMS-986258 2400 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 1 Day 13.11 Hours
Part A: BMS-986258 2400 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 3 Day 12 Hours
Part B: BMS-986258 480 mg + NIVO 480 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 3 Day 10.499 Hours
Part B: BMS-986258 480 mg + NIVO 480 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 1 Day 10.812 Hours
Part B: BMS-986258 800 mg + NIVO 480 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 3 Day 10.467 Hours
Part B: BMS-986258 800 mg + NIVO 480 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 1 Day 14.18 Hours
Part B: BMS-986258 1200 mg + NIVO 480 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 1 Day 11.02 Hours
Part B: BMS-986258 1200 mg + NIVO 480 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 3 Day 12.02 Hours
Part B: BMS-986258 1600 mg + NIVO 480 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 1 Day 12.29 Hours
Part B: BMS-986258 1600 mg + NIVO 480 mgTime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 3 Day 12.74 Hours
Part A1: BMS-986258 1200 mg + ENHANZETime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 1 Day 291.26 Hours
Part A1: BMS-986258 1200 mg + ENHANZETime to Reach Maximum Concentration (Tmax) of BMS-986258Cycle 1 Day 1123 Hours

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026