Trial Outcomes & Findings for A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors (NCT NCT06024174)

NCT ID: NCT06024174

Last Updated: 2025-07-22

Results Overview

A DLT was defined as: * Death not related to disease progression * Grade (Gr) 4 (Life-threatening) neurotoxicity * Gr 3 (Severe) neurotoxicity of greater than 7 days * Gr 3 neurotoxicity does not revert to baseline within 28 days of the start date of the Grade 3 event * Seizures of grade that do not resolve within 7 days * Gr 4 cytokine release syndrome (CRS) that does not resolve to less than or equal to Gr 3 within 3 days * Gr 3 CRS that does not resolve to less than or equal to Grade 2 within 7 days * Any increase in aspartate aminotransferase (AST) or ALT \\\> 3 Ã- ULN and concurrent increase in total bilirubin \\\> 2 Ã- ULN that is unrelated to CRS and has no other probable reason to explain the combination of increases * Any other Gr 3 or 4 event deemed unexpected by the Investigator and considered a DLT upon evaluation by the safety review committee

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: Cycle 1 (Each cycle consist of 28 days)
• Results posted on: 2025-07-22

Participant Flow

Study was early terminated and participants were not enrolled in Part 1A and 1B (Dose Escalation) and Part 2A and 2B (Dose Expansion).

Participant milestones

Measure	Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.
Overall Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.
Overall Study Other Reasons	1
Overall Study Study terminated by Sponsor	4

Baseline Characteristics

A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors

Baseline characteristics by cohort

Measure	Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID n=5 Participants Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.
Age, Continuous	55.2 years STANDARD_DEVIATION 7.16 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	1 Participants n=5 Participants
Race/Ethnicity, Customized WHITE	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Cycle 1 (Each cycle consist of 28 days)

Population: All treated participants were considered DLT evaluable if they complete ≥ 75% of all planned doses of BMS-986466 and adagrasib without experiencing a DLT or experience a DLT after receiving at least 1 dose of BMS-986466 and adagrasib. Participants were not enrolled in Part 1a, 1b. Prespecified to be collected for Part 1 only

A DLT was defined as:

• Death not related to disease progression
• Grade (Gr) 4 (Life-threatening) neurotoxicity
• Gr 3 (Severe) neurotoxicity of greater than 7 days
• Gr 3 neurotoxicity does not revert to baseline within 28 days of the start date of the Grade 3 event
• Seizures of grade that do not resolve within 7 days
• Gr 4 cytokine release syndrome (CRS) that does not resolve to less than or equal to Gr 3 within 3 days
• Gr 3 CRS that does not resolve to less than or equal to Grade 2 within 7 days
• Any increase in aspartate aminotransferase (AST) or ALT \> 3 Ã- ULN and concurrent increase in total bilirubin \> 2 Ã- ULN that is unrelated to CRS and has no other probable reason to explain the combination of increases
• Any other Gr 3 or 4 event deemed unexpected by the Investigator and considered a DLT upon evaluation by the safety review committee

Outcome measures

Measure	Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID n=2 Participants Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.	Part 2B Part 2B were planned to evaluate BMS-986466 in combination with adagrasib with or without cetuximab in KRAS G12C-mutant(G12C inhibitor treatment-naïve) CRC participants.
Part 1: Number of Participants With Dose Limiting Toxicity (DLTs)	0 Participants	—

PRIMARY outcome

Timeframe: From first dose until 100 days after last dose (Up to approximately 5 months)

Population: All treated population include all participants who received at least 1 dose of study intervention. Participants were not enrolled in Part 1a, 1b. Prespecified to be collected for Part 1 only

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Outcome measures

Measure	Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID n=5 Participants Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.	Part 2B Part 2B were planned to evaluate BMS-986466 in combination with adagrasib with or without cetuximab in KRAS G12C-mutant(G12C inhibitor treatment-naïve) CRC participants.
Part 1: Number of Participants With Adverse Events (AEs)	4 Participants	—

PRIMARY outcome

Timeframe: From first dose until 30 days after last dose (Up to approximately 3 months)

Population: All treated population include all participants who received at least 1 dose of study intervention. Participants were not enrolled in Part 1a, 1b. Prespecified to be collected for Part 1 only

A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event.

Outcome measures

Measure	Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID n=5 Participants Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.	Part 2B Part 2B were planned to evaluate BMS-986466 in combination with adagrasib with or without cetuximab in KRAS G12C-mutant(G12C inhibitor treatment-naïve) CRC participants.
Part 1: Number of Participants With Serious Adverse Events (SAEs)	1 Participants	—

PRIMARY outcome

Timeframe: From first dose until 30 days after last dose (Up to approximately 3 months)

Population: All treated population include all participants who received at least 1 dose of study intervention. Participants were not enrolled in Part 1a, 1b. Prespecified to be collected for Part 1 only.

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatmen

Outcome measures

Measure	Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID n=5 Participants Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.	Part 2B Part 2B were planned to evaluate BMS-986466 in combination with adagrasib with or without cetuximab in KRAS G12C-mutant(G12C inhibitor treatment-naïve) CRC participants.
Part 1: Number of Participants With AEs Leading to Discontinuation	0 Participants	—

PRIMARY outcome

Timeframe: From first dose until 100 days after last dose (Up to approximately 5 months)

Population: All treated population include all participants who received at least 1 dose of study intervention. Participants were not enrolled in Part 1a, 1b. Prespecified to be collected for Part 1 only.

Death due to any cause was assessed.

Outcome measures

Measure	Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID n=5 Participants Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.	Part 2B Part 2B were planned to evaluate BMS-986466 in combination with adagrasib with or without cetuximab in KRAS G12C-mutant(G12C inhibitor treatment-naïve) CRC participants.
Part 1: Number of Participants Who Died	0 Participants	—

PRIMARY outcome

Timeframe: From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months)

Population: All treated population include all participants who received at least 1 dose of study intervention. Participants were not enrolled in Part 2, hence participants analyzed is 0. Prespecified to be collected for Part 2 only

Objective Response Rate (ORR) is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (Each cycle consist of 28 days)

Population: Pharmacokinetic (PK) evaluable population is a subset of PK participants (all participants who received at least 1 dose of BMS-986466 and/or adagrasib and had any available concentration-time data) which consist of all participants in the PK population with adequate PK profiles. Prespecified to be collected for Part 1 only

Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b.

Outcome measures

Measure	Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID n=5 Participants Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.	Part 2B Part 2B were planned to evaluate BMS-986466 in combination with adagrasib with or without cetuximab in KRAS G12C-mutant(G12C inhibitor treatment-naïve) CRC participants.
Part 1: Maximum Observed Plasma Concentration (Cmax)	NA ng/mL Geometric Coefficient of Variation NA No participants had adequate PK profiles (below lower limit of quantification).	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (Each cycle consist of 28 days)

Population: Pharmacokinetic (PK) evaluable population is a subset of PK participants (all participants who received at least 1 dose of BMS-986466 and/or adagrasib and had any available concentration-time data) which consist of all participants in the PK population with adequate PK profiles. Prespecified to be collected for Part 1 only

Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b.

Outcome measures

Measure	Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID n=5 Participants Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.	Part 2B Part 2B were planned to evaluate BMS-986466 in combination with adagrasib with or without cetuximab in KRAS G12C-mutant(G12C inhibitor treatment-naïve) CRC participants.
Part 1: Time to Maximum Concentration (Tmax)	NA hours Geometric Coefficient of Variation NA No participants had adequate PK profiles (below lower limit of quantification).	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (Each cycle consist of 28 days)

Population: Pharmacokinetic (PK) evaluable population is a subset of PK participants (all participants who received at least 1 dose of BMS-986466 and/or adagrasib and had any available concentration-time data) which consist of all participants in the PK population with adequate PK profiles. Prespecified to be collected for Part 1 only.

Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b.

Outcome measures

Measure	Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID n=5 Participants Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.	Part 2B Part 2B were planned to evaluate BMS-986466 in combination with adagrasib with or without cetuximab in KRAS G12C-mutant(G12C inhibitor treatment-naïve) CRC participants.
Part 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T])	NA mcg*hr/mL Geometric Coefficient of Variation NA No participants had adequate PK profiles (below lower limit of quantification).	—

SECONDARY outcome

Timeframe: From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months)

Population: Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only

Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on Investigator assessments (per RECIST v1.1), or death due to any cause, whichever occurs first Calculated using Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months)

Population: Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only

Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months)

Population: Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only

Duration of objective response (DoR) is defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) per BICR assessment, or death due to any cause, whichever occurs first.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months)

Population: Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only

Time to response (TTR) is defined as the time, in months, from randomization to the first objective documentation of PR or better assessed per BICR.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose until 100 days after last dose (Up to approximately 5 months)

Population: Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose until 100 days after last dose (Up to approximately 5 months)

Population: Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only

A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose until 100 days after last dose (Up to approximately 5 months)

Population: Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose until 100 days after last dose (Up to approximately 5 months)

Population: Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only

Death due to any cause was assessed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Cycle 1 Day 1 (Each cycle consist of 28 days)

Population: All treated participants with available biomarker data. Participants were not enrolled in Part 1a and 1b arm, hence participants analyzed is 0. Prespecified to be collected for Part 1A and 1B only.

Blood samples were collected for assessing pharmacodynamic parameters.

Outcome measures

Outcome data not reported

Adverse Events

Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure

Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID n=5 participants at risk Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.

General disorders Pyrexia

20.0% 1/5 • All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months). All treated population include all participants who received at least 1 dose of study intervention.

Other adverse events

Measure	Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID n=5 participants at risk Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4.
Gastrointestinal disorders Constipation	40.0% 2/5 • All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months). All treated population include all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Diarrhoea	40.0% 2/5 • All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months). All treated population include all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Epigastric discomfort	20.0% 1/5 • All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months). All treated population include all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Nausea	40.0% 2/5 • All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months). All treated population include all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Proctalgia	20.0% 1/5 • All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months). All treated population include all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Vomiting	20.0% 1/5 • All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months). All treated population include all participants who received at least 1 dose of study intervention.
General disorders Fatigue	20.0% 1/5 • All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months). All treated population include all participants who received at least 1 dose of study intervention.
Investigations Alanine aminotransferase increased	20.0% 1/5 • All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months). All treated population include all participants who received at least 1 dose of study intervention.
Investigations Amylase increased	20.0% 1/5 • All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months). All treated population include all participants who received at least 1 dose of study intervention.
Investigations Aspartate aminotransferase increased	20.0% 1/5 • All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months). All treated population include all participants who received at least 1 dose of study intervention.
Investigations Lipase increased	20.0% 1/5 • All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months). All treated population include all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Decreased appetite	20.0% 1/5 • All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months). All treated population include all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Dehydration	20.0% 1/5 • All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months). All treated population include all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Muscle spasms	20.0% 1/5 • All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months). All treated population include all participants who received at least 1 dose of study intervention.
Nervous system disorders Somnolence	20.0% 1/5 • All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months). All treated population include all participants who received at least 1 dose of study intervention.
Vascular disorders Hypotension	20.0% 1/5 • All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months). All treated population include all participants who received at least 1 dose of study intervention.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
• Publication restrictions are in place

Restriction type: OTHER