Advanced Cancer
Conditions
Brief summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986148 administered alone and in combination with nivolumab in patients with mesothelioma, non-small cell lung cancer, ovarian cancer, pancreatic cancer and gastric cancer.
Interventions
DRUGBMS-986148
BIOLOGICALNivolumab
Sponsors
Bristol-Myers Squibb
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
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Must have pancreatic, ovarian, gastric, non-small cell cancer or mesothelioma. For dose expansion, must have tumor that is positive for mesothelin * Expected to have life expectancy of at least 3 months * Men and women 18 years old or older (or local age of majority) * Must have measurable tumor per Response Evaluation Criteria In Solid Tumors (RECIST) or modified RECIST for malignant pleural mesothelioma * ECOG of 0 to 1
Exclusion criteria
* Cancer metastases in the brain * Moderate eye disorders * Active infection or past hepatitis B or C infection * Major surgery less than 1 month before the start of the study * Uncontrolled heart disease * Impaired liver or bone marrow function * History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies, nivolumab or related compounds
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events at Worst CTC Grade | From first dose to up to 100 days post last dose (Up to 6 months) | Number of participants with adverse events at worst CTC grade including any grade adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuations, and deaths grouped by dose + dose regimen. |
| Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | From first dose to up to 100 days post last dose (Up to 6 months) | Number of participants with laboratory test toxicity grade (Grade 0, 1, 2, 3, and 4) in hematology and chemistry shifting from baseline. An increase in baseline indicates a shift of participant to a greater toxicity grade. A decrease in baseline indicates a shift of participant to a lesser toxicity grade. Participants are grouped by dose + dose regimen assessed by NCT CTCAE V 4.03. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration at the End of a Dosing Interval (Ctau) | PK blood assessed on cycle 1, day 1 | Concentration at the end of a dosing interval (Ctau) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead. |
| Trough Observed Serum Concentration (Ctrough) | PK blood assessment include cycle 2-day 1 and cycle 1-day 8 | Trough observed serum concentration (Ctrough) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead. |
| Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | PK blood assessment include cycle 1-day 1 | Area under the concentration-time curve from time Zero to time T (AUC(0-t)) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead. |
| Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | PK blood assessment include cycle 1-day 1 | Area under the concentration-time curve in one dosing interval (AUC\[TAU\]) of BMS-986148 grouped by dose + dose regimen Note: The geometric CV was not calculated. Arithmetic % CV is reported instead |
| Best Overall Response (BOR) | Up to 58 months | Best overall response is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes 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 on study. The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Maximum Observed Serum Concentration (Cmax) | PK blood assessed on cycle 1, day 1 | Maximum observed serum concentration (Cmax) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead. |
| Duration of Response (DoR) | Up to 58 months | Duration of response is defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric). |
| Progression Free Survival (PFS) | Up to 58 months | Progression Free Survival 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. Progression is defined with at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. Participants who did not progress nor died will be censored on the date of their last tumor assessment. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric). |
| Progression Free Survival Rate (PFSR) at Week t | Total PFS assessed between 4 and 12 months, PFSR at months 4 and 6 to be reported | Progression free survival rate is defined as the proportion of participants who remain progression free and surviving at 't' weeks (t=4-12 months). The proportion will be calculated by the product-limit method (Kaplan-Meier estimate) which takes into account censored data. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric). |
| Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | Up to 58 months | Changes of participants in QT corrected by the fridericia formula (QTcF) Interval from baseline at \<= 30 msec, \>30 - \<= 60 msec, and \> 60 msec grouped by dose + dose regimen |
| Number of Participants With Anti-Drug Antibody (ADA) | Up to 58 months | Number of participants with anti-drug antibody (ADA) status grouped by dose + dose regimen. Data was not collected for this outcome measure. |
| Objective Response Rate (ORR) | Up to 58 months | Objective response rate is defined as the total percentage of participants whose best overall response (BOR) is either a complete response or partial response divided by the total percentage of participants who are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes 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. |
| Time of Maximum Observed Serum Concentration (Tmax) | PK blood assessed on cycle 1, day 1 | Time of maximum observed serum concentration (Tmax) of BMS-986148 grouped by dose + dose regimen. |
Countries
Australia, Belgium, Canada, Italy, Netherlands, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BMS-986148 0.1MG/KG Q3W Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle | 2 |
| BMS-986148 0.2MG/KG Q3W Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle | 2 |
| BMS-986148 0.4MG/KG Q3W Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle | 3 |
| BMS-986148 0.8MG/KG Q3W Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle | 8 |
| BMS-986148 1.2MG/KG Q3W Es Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W | 8 |
| BMS-986148 1.6MG/KG Q3W Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle | 10 |
| BMS-986148 1.2MG/KG Q3W Ex Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | 51 |
| BMS-986148 0.4MG/KG QW Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | 8 |
| BMS-986148 0.6MG/KG QW Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle | 4 |
| BMS 0.8MG/KG + Nivolumab Q3W Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer | 30 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event Unrelated to Study Drug | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 2 |
| Overall Study | Completed Treatment as per Protocol | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Disease Progression | 2 | 2 | 3 | 6 | 7 | 7 | 28 | 5 | 4 | 19 |
| Overall Study | Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Overall Study | Other Reasons | 0 | 0 | 0 | 0 | 1 | 0 | 5 | 0 | 0 | 2 |
| Overall Study | Participant Request to Discontinue Study Treatment | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 2 | 0 | 0 |
| Overall Study | Participant Withdrew Consent | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Study Drug Toxicity | 0 | 0 | 0 | 1 | 0 | 3 | 10 | 0 | 0 | 3 |
Baseline characteristics
| Characteristic | BMS-986148 1.2MG/KG Q3W Ex | Total | BMS 0.8MG/KG + Nivolumab Q3W | BMS-986148 0.6MG/KG QW | BMS-986148 0.4MG/KG QW | BMS-986148 0.1MG/KG Q3W | BMS-986148 0.2MG/KG Q3W | BMS-986148 0.4MG/KG Q3W | BMS-986148 0.8MG/KG Q3W | BMS-986148 1.2MG/KG Q3W Es | BMS-986148 1.6MG/KG Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 61.5 Years STANDARD_DEVIATION 9.5 | 62.2 Years STANDARD_DEVIATION 9.4 | 61.6 Years STANDARD_DEVIATION 9.4 | 64.5 Years STANDARD_DEVIATION 9.1 | 66.3 Years STANDARD_DEVIATION 8.6 | 59.5 Years STANDARD_DEVIATION 0.7 | 70.5 Years STANDARD_DEVIATION 0.7 | 65.3 Years STANDARD_DEVIATION 5.8 | 63.9 Years STANDARD_DEVIATION 5.4 | 63.4 Years STANDARD_DEVIATION 5.1 | 59.0 Years STANDARD_DEVIATION 16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 114 Participants | 25 Participants | 3 Participants | 8 Participants | 2 Participants | 1 Participants | 3 Participants | 8 Participants | 8 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 11 Participants | 5 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 46 Participants | 116 Participants | 30 Participants | 3 Participants | 8 Participants | 1 Participants | 2 Participants | 3 Participants | 7 Participants | 7 Participants | 9 Participants |
| Sex: Female, Male Female | 31 Participants | 59 Participants | 12 Participants | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 20 Participants | 67 Participants | 18 Participants | 2 Participants | 5 Participants | 2 Participants | 2 Participants | 1 Participants | 5 Participants | 5 Participants | 7 Participants |
Adverse events
| Event type | EG000 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 |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 2 | 2 / 2 | 3 / 3 | 5 / 8 | 7 / 10 | 38 / 59 | 7 / 8 | 4 / 4 | 22 / 30 |
| other Total, other adverse events | 1 / 2 | 2 / 2 | 3 / 3 | 8 / 8 | 10 / 10 | 57 / 59 | 8 / 8 | 4 / 4 | 27 / 30 |
| serious Total, serious adverse events | 1 / 2 | 1 / 2 | 1 / 3 | 5 / 8 | 4 / 10 | 32 / 59 | 6 / 8 | 3 / 4 | 21 / 30 |
Outcome results
Primary
Number of Participants With Adverse Events at Worst CTC Grade
Number of participants with adverse events at worst CTC grade including any grade adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuations, and deaths grouped by dose + dose regimen.
Time frame: From first dose to up to 100 days post last dose (Up to 6 months)
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | Adverse Events (AEs) | 1 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | Serious Adverse Events (SAEs) | 1 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | AEs Leading to Discontinuation | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | Deaths | 1 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | Deaths | 2 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | Adverse Events (AEs) | 2 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | Serious Adverse Events (SAEs) | 1 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | AEs Leading to Discontinuation | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | Serious Adverse Events (SAEs) | 1 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | Deaths | 3 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | AEs Leading to Discontinuation | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | Adverse Events (AEs) | 3 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | Adverse Events (AEs) | 8 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | Serious Adverse Events (SAEs) | 5 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | AEs Leading to Discontinuation | 1 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | Deaths | 5 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | AEs Leading to Discontinuation | 3 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | Serious Adverse Events (SAEs) | 4 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | Adverse Events (AEs) | 10 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Adverse Events at Worst CTC Grade | Deaths | 7 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Adverse Events at Worst CTC Grade | Deaths | 38 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Adverse Events at Worst CTC Grade | Adverse Events (AEs) | 59 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Adverse Events at Worst CTC Grade | AEs Leading to Discontinuation | 11 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Adverse Events at Worst CTC Grade | Serious Adverse Events (SAEs) | 32 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Adverse Events at Worst CTC Grade | AEs Leading to Discontinuation | 1 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Adverse Events at Worst CTC Grade | Serious Adverse Events (SAEs) | 6 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Adverse Events at Worst CTC Grade | Deaths | 7 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Adverse Events at Worst CTC Grade | Adverse Events (AEs) | 8 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Adverse Events at Worst CTC Grade | Serious Adverse Events (SAEs) | 3 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Adverse Events at Worst CTC Grade | Deaths | 4 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Adverse Events at Worst CTC Grade | AEs Leading to Discontinuation | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Adverse Events at Worst CTC Grade | Adverse Events (AEs) | 4 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Adverse Events at Worst CTC Grade | Adverse Events (AEs) | 30 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Adverse Events at Worst CTC Grade | Deaths | 22 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Adverse Events at Worst CTC Grade | AEs Leading to Discontinuation | 7 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Adverse Events at Worst CTC Grade | Serious Adverse Events (SAEs) | 21 Participants |
Primary
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline
Number of participants with laboratory test toxicity grade (Grade 0, 1, 2, 3, and 4) in hematology and chemistry shifting from baseline. An increase in baseline indicates a shift of participant to a greater toxicity grade. A decrease in baseline indicates a shift of participant to a lesser toxicity grade. Participants are grouped by dose + dose regimen assessed by NCT CTCAE V 4.03.
Time frame: From first dose to up to 100 days post last dose (Up to 6 months)
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus increase from baseline | 2 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes increase from baseline | 1 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium increase from baseline | 1 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin increase from baseline | 1 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium decrease from baseline | 1 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) decrease from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine increase from baseline | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) increase from baseline | 1 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid increase from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin increase from baseline | 1 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum increase from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase increase from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) increase from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin increase from baseline | 1 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine increase from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes increase from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus increase from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total increase from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium increase from baseline | 1 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase increase from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium increase from baseline | 1 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils increase from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count increase from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes increase from baseline | 2 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil increase from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase increase from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected increase from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) increase from baseline | 1 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium increase from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin decrease from baseline | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium decrease from baseline | 1 Participants |
| BMS-986148 0.2MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin increase from baseline | 1 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes increase from baseline | 1 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine increase from baseline | 1 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid increase from baseline | 1 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium increase from baseline | 1 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus increase from baseline | 2 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium increase from baseline | 1 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes increase from baseline | 1 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) increase from baseline | 1 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) increase from baseline | 1 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes decrease from baseline | 1 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin decrease from baseline | 1 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase increase from baseline | 1 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes increase from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin increase from baseline | 3 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin decrease from baseline | 1 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count increase from baseline | 3 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils increase from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes increase from baseline | 3 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil increase from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) increase from baseline | 6 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) increase from baseline | 6 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) increase from baseline | 7 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin increase from baseline | 2 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine increase from baseline | 2 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium increase from baseline | 4 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium increase from baseline | 3 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total increase from baseline | 5 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected increase from baseline | 2 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus increase from baseline | 3 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium increase from baseline | 2 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum increase from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin increase from baseline | 7 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase increase from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase increase from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase increase from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid increase from baseline | 1 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected increase from baseline | 1 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium increase from baseline | 5 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) increase from baseline | 10 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes increase from baseline | 6 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin increase from baseline | 8 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil increase from baseline | 2 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase increase from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium increase from baseline | 4 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin increase from baseline | 3 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes increase from baseline | 2 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine increase from baseline | 2 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils increase from baseline | 1 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total increase from baseline | 4 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum increase from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) increase from baseline | 10 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) increase from baseline | 10 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase increase from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase increase from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus increase from baseline | 4 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid increase from baseline | 2 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin increase from baseline | 3 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count increase from baseline | 4 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) decrease from baseline | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium increase from baseline | 4 Participants |
| BMS-986148 1.6MG/KG Q3W | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) decrease from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine increase from baseline | 7 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum increase from baseline | 6 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes increase from baseline | 1 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase decrease from baseline | 1 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum decrease from baseline | 1 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin increase from baseline | 37 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium increase from baseline | 23 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count decrease from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase increase from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin decrease from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count increase from baseline | 14 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil decrease from baseline | 1 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) decrease from baseline | 1 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium decrease from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) decrease from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase decrease from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid increase from baseline | 6 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium increase from baseline | 24 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin increase from baseline | 16 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil increase from baseline | 3 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium decrease from baseline | 3 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) increase from baseline | 50 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes decrease from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase increase from baseline | 9 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total increase from baseline | 17 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total decrease from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) decrease from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes increase from baseline | 27 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected increase from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin decrease from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected decrease from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) increase from baseline | 46 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils decrease from baseline | 1 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase increase from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin increase from baseline | 20 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus increase from baseline | 24 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine decrease from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils increase from baseline | 3 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus decrease from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin decrease from baseline | 3 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid decrease from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium increase from baseline | 22 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes decrease from baseline | 1 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium decrease from baseline | 3 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase decrease from baseline | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) increase from baseline | 53 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin increase from baseline | 2 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium increase from baseline | 1 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes decrease from baseline | 1 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes increase from baseline | 1 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus increase from baseline | 1 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) increase from baseline | 6 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin increase from baseline | 2 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus decrease from baseline | 1 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium increase from baseline | 1 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total increase from baseline | 3 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes decrease from baseline | 1 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine increase from baseline | 1 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) increase from baseline | 5 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes increase from baseline | 6 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium increase from baseline | 1 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin increase from baseline | 6 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected increase from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) decrease from baseline | 0 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) increase from baseline | 5 Participants |
| BMS-986148 0.4MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine increase from baseline | 3 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) increase from baseline | 4 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium increase from baseline | 2 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil increase from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium increase from baseline | 2 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total increase from baseline | 1 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes increase from baseline | 3 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase increase from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected increase from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus increase from baseline | 2 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils increase from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium increase from baseline | 2 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes increase from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum increase from baseline | 1 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin increase from baseline | 2 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count increase from baseline | 1 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase increase from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase increase from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin increase from baseline | 1 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid increase from baseline | 2 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) increase from baseline | 3 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) increase from baseline | 4 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) decrease from baseline | 0 Participants |
| BMS-986148 0.6MG/KG QW | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin increase from baseline | 2 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes increase from baseline | 2 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium decrease from baseline | 1 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Magnesium increase from baseline | 5 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Leukocytes decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid increase from baseline | 6 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Phosphorus increase from baseline | 7 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils increase from baseline | 1 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase increase from baseline | 1 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin increase from baseline | 12 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatinine increase from baseline | 5 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase increase from baseline | 3 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lipase decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) increase from baseline | 24 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Neutrophils decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Corrected increase from baseline | 1 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total decrease from baseline | 1 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes increase from baseline | 19 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Calcium Total increase from baseline | 10 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Lymphocytes decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) increase from baseline | 25 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Potassium increase from baseline | 9 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Aspartate Aminotransferase (AST) increase from baseline | 26 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alkaline Phosphatase (ALP) decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Absolute Neutrophil increase from baseline | 2 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Uric Acid decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Bilirubin increase from baseline | 7 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Creatine Kinase decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count increase from baseline | 6 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Albumin increase from baseline | 19 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Alanine Aminotransferase (ALT) decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Amylase increase from baseline | 1 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Platelet Count decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Hemoglobin decrease from baseline | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Sodium increase from baseline | 17 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum decrease from baseline | 1 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | Glucose Fasting Serum increase from baseline | 5 Participants |
Secondary
Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t))
Area under the concentration-time curve from time Zero to time T (AUC(0-t)) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Time frame: PK blood assessment include cycle 1-day 1
Population: All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-986148 0.1MG/KG Q3W | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Total Antibody | 152.6 h*ug/mL | Geometric Coefficient of Variation 31.6 |
| BMS-986148 0.1MG/KG Q3W | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Active Antibody-Drug Conjugate (ADC) | 88.6 h*ug/mL | Geometric Coefficient of Variation 48.7 |
| BMS-986148 0.2MG/KG Q3W | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Total Antibody | 232.5 h*ug/mL | Geometric Coefficient of Variation 17.5 |
| BMS-986148 0.2MG/KG Q3W | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Active Antibody-Drug Conjugate (ADC) | 70.7 h*ug/mL | Geometric Coefficient of Variation 42.9 |
| BMS-986148 0.4MG/KG Q3W | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Active Antibody-Drug Conjugate (ADC) | 60.8 h*ug/mL | Geometric Coefficient of Variation 136.2 |
| BMS-986148 0.4MG/KG Q3W | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Total Antibody | 129.6 h*ug/mL | Geometric Coefficient of Variation 131.3 |
| BMS-986148 0.4MG/KG Q3W | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Unconjugated Tubulysin | 49.6 h*ug/mL | — |
| BMS-986148 0.8MG/KG Q3W | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Unconjugated Tubulysin | 29.6 h*ug/mL | Geometric Coefficient of Variation 42.8 |
| BMS-986148 0.8MG/KG Q3W | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Active Antibody-Drug Conjugate (ADC) | 1042.1 h*ug/mL | Geometric Coefficient of Variation 68.6 |
| BMS-986148 0.8MG/KG Q3W | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Total Antibody | 1979.5 h*ug/mL | Geometric Coefficient of Variation 69.6 |
| BMS-986148 1.6MG/KG Q3W | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Active Antibody-Drug Conjugate (ADC) | 3083.6 h*ug/mL | Geometric Coefficient of Variation 32.3 |
| BMS-986148 1.6MG/KG Q3W | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Total Antibody | 5399.8 h*ug/mL | Geometric Coefficient of Variation 40.1 |
| BMS-986148 1.6MG/KG Q3W | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Unconjugated Tubulysin | 80.1 h*ug/mL | Geometric Coefficient of Variation 73.4 |
| BMS-986148 1.2MG/KG Q3W Es | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Unconjugated Tubulysin | 197.0 h*ug/mL | Geometric Coefficient of Variation 59.4 |
| BMS-986148 1.2MG/KG Q3W Es | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Total Antibody | 4285.7 h*ug/mL | Geometric Coefficient of Variation 29.3 |
| BMS-986148 1.2MG/KG Q3W Es | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Active Antibody-Drug Conjugate (ADC) | 2493.1 h*ug/mL | Geometric Coefficient of Variation 25.1 |
| BMS-986148 0.4MG/KG QW | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Total Antibody | 3472.6 h*ug/mL | Geometric Coefficient of Variation 47.1 |
| BMS-986148 0.4MG/KG QW | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Active Antibody-Drug Conjugate (ADC) | 1984.7 h*ug/mL | Geometric Coefficient of Variation 45.7 |
| BMS-986148 0.4MG/KG QW | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Unconjugated Tubulysin | 42.3 h*ug/mL | Geometric Coefficient of Variation 80.4 |
| BMS-986148 0.6MG/KG QW | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Unconjugated Tubulysin | 9.3 h*ug/mL | Geometric Coefficient of Variation 73 |
| BMS-986148 0.6MG/KG QW | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Total Antibody | 858.0 h*ug/mL | Geometric Coefficient of Variation 22.9 |
| BMS-986148 0.6MG/KG QW | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Active Antibody-Drug Conjugate (ADC) | 565.4 h*ug/mL | Geometric Coefficient of Variation 30.3 |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Unconjugated Tubulysin | 42.5 h*ug/mL | Geometric Coefficient of Variation 84.3 |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Total Antibody | 1278.8 h*ug/mL | Geometric Coefficient of Variation 35.1 |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Active Antibody-Drug Conjugate (ADC) | 927.3 h*ug/mL | Geometric Coefficient of Variation 38.7 |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Total Antibody | 1815.8 h*ug/mL | Geometric Coefficient of Variation 43.4 |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Active Antibody-Drug Conjugate (ADC) | 1059.0 h*ug/mL | Geometric Coefficient of Variation 44.8 |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Unconjugated Tubulysin | 25.5 h*ug/mL | Geometric Coefficient of Variation 58.8 |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Active Antibody-Drug Conjugate (ADC) | 1447.5 h*ug/mL | Geometric Coefficient of Variation 36.2 |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Total Antibody | 2611.3 h*ug/mL | Geometric Coefficient of Variation 33.5 |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | Unconjugated Tubulysin | 17.7 h*ug/mL | Geometric Coefficient of Variation 110.3 |
Secondary
Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])
Area under the concentration-time curve in one dosing interval (AUC\[TAU\]) of BMS-986148 grouped by dose + dose regimen Note: The geometric CV was not calculated. Arithmetic % CV is reported instead
Time frame: PK blood assessment include cycle 1-day 1
Population: All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-986148 0.1MG/KG Q3W | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Active Antibody-Drug Conjugate (ADC) | 109.0 h*ug/mL | Geometric Coefficient of Variation 35.2 |
| BMS-986148 0.1MG/KG Q3W | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Total Antibody | 179.3 h*ug/mL | Geometric Coefficient of Variation 34.8 |
| BMS-986148 0.2MG/KG Q3W | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Total Antibody | 265.7 h*ug/mL | Geometric Coefficient of Variation 13.3 |
| BMS-986148 0.4MG/KG Q3W | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Active Antibody-Drug Conjugate (ADC) | 371.6 h*ug/mL | — |
| BMS-986148 0.4MG/KG Q3W | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Total Antibody | 344.6 h*ug/mL | Geometric Coefficient of Variation 98.5 |
| BMS-986148 0.8MG/KG Q3W | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Total Antibody | 2059.3 h*ug/mL | Geometric Coefficient of Variation 68.7 |
| BMS-986148 0.8MG/KG Q3W | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Active Antibody-Drug Conjugate (ADC) | 1098.7 h*ug/mL | Geometric Coefficient of Variation 67.5 |
| BMS-986148 1.6MG/KG Q3W | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Total Antibody | 5318.6 h*ug/mL | Geometric Coefficient of Variation 36.9 |
| BMS-986148 1.6MG/KG Q3W | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Unconjugated Tubulysin | 173.4 h*ug/mL | Geometric Coefficient of Variation 48.2 |
| BMS-986148 1.6MG/KG Q3W | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Active Antibody-Drug Conjugate (ADC) | 3246.0 h*ug/mL | Geometric Coefficient of Variation 36.6 |
| BMS-986148 1.2MG/KG Q3W Es | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Total Antibody | 4316.1 h*ug/mL | Geometric Coefficient of Variation 28.8 |
| BMS-986148 1.2MG/KG Q3W Es | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Unconjugated Tubulysin | 197.0 h*ug/mL | Geometric Coefficient of Variation 59.4 |
| BMS-986148 1.2MG/KG Q3W Es | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Active Antibody-Drug Conjugate (ADC) | 2507.2 h*ug/mL | Geometric Coefficient of Variation 24.7 |
| BMS-986148 0.4MG/KG QW | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Unconjugated Tubulysin | 148.9 h*ug/mL | Geometric Coefficient of Variation 30.3 |
| BMS-986148 0.4MG/KG QW | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Total Antibody | 4159.4 h*ug/mL | Geometric Coefficient of Variation 39.5 |
| BMS-986148 0.4MG/KG QW | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Active Antibody-Drug Conjugate (ADC) | 2271.7 h*ug/mL | Geometric Coefficient of Variation 40.1 |
| BMS-986148 0.6MG/KG QW | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Active Antibody-Drug Conjugate (ADC) | 565.4 h*ug/mL | Geometric Coefficient of Variation 30.3 |
| BMS-986148 0.6MG/KG QW | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Unconjugated Tubulysin | 9.3 h*ug/mL | Geometric Coefficient of Variation 73 |
| BMS-986148 0.6MG/KG QW | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Total Antibody | 858.0 h*ug/mL | Geometric Coefficient of Variation 22.9 |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Unconjugated Tubulysin | 42.5 h*ug/mL | Geometric Coefficient of Variation 84.3 |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Total Antibody | 1533.5 h*ug/mL | Geometric Coefficient of Variation 19.2 |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Active Antibody-Drug Conjugate (ADC) | 1063.9 h*ug/mL | Geometric Coefficient of Variation 32.2 |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Total Antibody | 1839.0 h*ug/mL | Geometric Coefficient of Variation 45.4 |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Active Antibody-Drug Conjugate (ADC) | 1094.9 h*ug/mL | Geometric Coefficient of Variation 48 |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Unconjugated Tubulysin | 102.4 h*ug/mL | — |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Total Antibody | 2689.9 h*ug/mL | Geometric Coefficient of Variation 34 |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | Active Antibody-Drug Conjugate (ADC) | 1478.1 h*ug/mL | Geometric Coefficient of Variation 36.6 |
Secondary
Best Overall Response (BOR)
Best overall response is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes 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 on study. The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: Up to 58 months
Population: Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BMS-986148 0.1MG/KG Q3W | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Best Overall Response (BOR) | Partial Response (PR) | 1 Participants |
| BMS-986148 0.1MG/KG Q3W | Best Overall Response (BOR) | Stable Disease (SD) | 13 Participants |
| BMS-986148 0.1MG/KG Q3W | Best Overall Response (BOR) | Progressive Disease (PD) | 7 Participants |
| BMS-986148 0.2MG/KG Q3W | Best Overall Response (BOR) | Partial Response (PR) | 3 Participants |
| BMS-986148 0.2MG/KG Q3W | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Best Overall Response (BOR) | Progressive Disease (PD) | 1 Participants |
| BMS-986148 0.2MG/KG Q3W | Best Overall Response (BOR) | Stable Disease (SD) | 8 Participants |
| BMS-986148 0.4MG/KG Q3W | Best Overall Response (BOR) | Partial Response (PR) | 2 Participants |
| BMS-986148 0.4MG/KG Q3W | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Best Overall Response (BOR) | Stable Disease (SD) | 11 Participants |
| BMS-986148 0.4MG/KG Q3W | Best Overall Response (BOR) | Progressive Disease (PD) | 7 Participants |
| BMS-986148 0.8MG/KG Q3W | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Best Overall Response (BOR) | Partial Response (PR) | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Best Overall Response (BOR) | Stable Disease (SD) | 2 Participants |
| BMS-986148 0.8MG/KG Q3W | Best Overall Response (BOR) | Progressive Disease (PD) | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Best Overall Response (BOR) | Stable Disease (SD) | 4 Participants |
| BMS-986148 1.6MG/KG Q3W | Best Overall Response (BOR) | Partial Response (PR) | 0 Participants |
| BMS-986148 1.6MG/KG Q3W | Best Overall Response (BOR) | Progressive Disease (PD) | 11 Participants |
| BMS-986148 1.6MG/KG Q3W | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Best Overall Response (BOR) | Stable Disease (SD) | 1 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Best Overall Response (BOR) | Partial Response (PR) | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Best Overall Response (BOR) | Progressive Disease (PD) | 2 Participants |
| BMS-986148 0.4MG/KG QW | Best Overall Response (BOR) | Partial Response (PR) | 0 Participants |
| BMS-986148 0.4MG/KG QW | Best Overall Response (BOR) | Stable Disease (SD) | 1 Participants |
| BMS-986148 0.4MG/KG QW | Best Overall Response (BOR) | Progressive Disease (PD) | 2 Participants |
| BMS-986148 0.4MG/KG QW | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| BMS-986148 0.6MG/KG QW | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| BMS-986148 0.6MG/KG QW | Best Overall Response (BOR) | Progressive Disease (PD) | 1 Participants |
| BMS-986148 0.6MG/KG QW | Best Overall Response (BOR) | Partial Response (PR) | 0 Participants |
| BMS-986148 0.6MG/KG QW | Best Overall Response (BOR) | Stable Disease (SD) | 1 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Best Overall Response (BOR) | Progressive Disease (PD) | 2 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Best Overall Response (BOR) | Stable Disease (SD) | 1 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Best Overall Response (BOR) | Partial Response (PR) | 0 Participants |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Best Overall Response (BOR) | Stable Disease (SD) | 0 Participants |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Best Overall Response (BOR) | Complete Response (CR) | 0 Participants |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Best Overall Response (BOR) | Progressive Disease (PD) | 1 Participants |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Best Overall Response (BOR) | Partial Response (PR) | 0 Participants |
Secondary
Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times
Changes of participants in QT corrected by the fridericia formula (QTcF) Interval from baseline at \<= 30 msec, \>30 - \<= 60 msec, and \> 60 msec grouped by dose + dose regimen
Time frame: Up to 58 months
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BMS-986148 0.1MG/KG Q3W | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | > 60 msec | 0 Participants |
| BMS-986148 0.1MG/KG Q3W | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | <= 30 msec, | 1 Participants |
| BMS-986148 0.1MG/KG Q3W | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | >30 - <= 60 msec | 1 Participants |
| BMS-986148 0.2MG/KG Q3W | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | >30 - <= 60 msec | 0 Participants |
| BMS-986148 0.2MG/KG Q3W | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | <= 30 msec, | 2 Participants |
| BMS-986148 0.2MG/KG Q3W | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | > 60 msec | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | > 60 msec | 0 Participants |
| BMS-986148 0.4MG/KG Q3W | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | <= 30 msec, | 2 Participants |
| BMS-986148 0.4MG/KG Q3W | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | >30 - <= 60 msec | 1 Participants |
| BMS-986148 0.8MG/KG Q3W | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | > 60 msec | 0 Participants |
| BMS-986148 0.8MG/KG Q3W | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | >30 - <= 60 msec | 2 Participants |
| BMS-986148 0.8MG/KG Q3W | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | <= 30 msec, | 6 Participants |
| BMS-986148 1.6MG/KG Q3W | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | >30 - <= 60 msec | 1 Participants |
| BMS-986148 1.6MG/KG Q3W | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | <= 30 msec, | 9 Participants |
| BMS-986148 1.6MG/KG Q3W | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | > 60 msec | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | <= 30 msec, | 8 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | > 60 msec | 0 Participants |
| BMS-986148 1.2MG/KG Q3W Es | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | >30 - <= 60 msec | 0 Participants |
| BMS-986148 0.4MG/KG QW | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | > 60 msec | 2 Participants |
| BMS-986148 0.4MG/KG QW | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | <= 30 msec, | 37 Participants |
| BMS-986148 0.4MG/KG QW | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | >30 - <= 60 msec | 12 Participants |
| BMS-986148 0.6MG/KG QW | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | >30 - <= 60 msec | 3 Participants |
| BMS-986148 0.6MG/KG QW | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | > 60 msec | 0 Participants |
| BMS-986148 0.6MG/KG QW | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | <= 30 msec, | 5 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | <= 30 msec, | 3 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | >30 - <= 60 msec | 1 Participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | > 60 msec | 0 Participants |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | >30 - <= 60 msec | 7 Participants |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | <= 30 msec, | 23 Participants |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times | > 60 msec | 0 Participants |
Secondary
Concentration at the End of a Dosing Interval (Ctau)
Concentration at the end of a dosing interval (Ctau) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Time frame: PK blood assessed on cycle 1, day 1
Population: All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-986148 0.1MG/KG Q3W | Concentration at the End of a Dosing Interval (Ctau) | Active Antibody-Drug Conjugate (ADC) | 0.0633 ug/mL | Geometric Coefficient of Variation 141.3 |
| BMS-986148 0.1MG/KG Q3W | Concentration at the End of a Dosing Interval (Ctau) | Total Antibody | 0.0035 ug/mL | Geometric Coefficient of Variation 112 |
| BMS-986148 0.2MG/KG Q3W | Concentration at the End of a Dosing Interval (Ctau) | Total Antibody | 0.0333 ug/mL | Geometric Coefficient of Variation 115.7 |
| BMS-986148 0.4MG/KG Q3W | Concentration at the End of a Dosing Interval (Ctau) | Active Antibody-Drug Conjugate (ADC) | 0.0058 ug/mL | — |
| BMS-986148 0.4MG/KG Q3W | Concentration at the End of a Dosing Interval (Ctau) | Total Antibody | 0.8233 ug/mL | Geometric Coefficient of Variation 131.8 |
| BMS-986148 0.8MG/KG Q3W | Concentration at the End of a Dosing Interval (Ctau) | Active Antibody-Drug Conjugate (ADC) | 0.0309 ug/mL | Geometric Coefficient of Variation 123.8 |
| BMS-986148 0.8MG/KG Q3W | Concentration at the End of a Dosing Interval (Ctau) | Total Antibody | 0.4426 ug/mL | Geometric Coefficient of Variation 106.1 |
| BMS-986148 1.6MG/KG Q3W | Concentration at the End of a Dosing Interval (Ctau) | Total Antibody | 1.4101 ug/mL | Geometric Coefficient of Variation 101.8 |
| BMS-986148 1.6MG/KG Q3W | Concentration at the End of a Dosing Interval (Ctau) | Active Antibody-Drug Conjugate (ADC) | 0.3049 ug/mL | Geometric Coefficient of Variation 110 |
| BMS-986148 1.6MG/KG Q3W | Concentration at the End of a Dosing Interval (Ctau) | Unconjugated Tubulysin | 0.1630 ug/mL | Geometric Coefficient of Variation 0.9 |
| BMS-986148 1.2MG/KG Q3W Es | Concentration at the End of a Dosing Interval (Ctau) | Active Antibody-Drug Conjugate (ADC) | 0.2121 ug/mL | Geometric Coefficient of Variation 111.3 |
| BMS-986148 1.2MG/KG Q3W Es | Concentration at the End of a Dosing Interval (Ctau) | Unconjugated Tubulysin | 0.2590 ug/mL | Geometric Coefficient of Variation 77.1 |
| BMS-986148 1.2MG/KG Q3W Es | Concentration at the End of a Dosing Interval (Ctau) | Total Antibody | 1.0917 ug/mL | Geometric Coefficient of Variation 91.9 |
| BMS-986148 0.4MG/KG QW | Concentration at the End of a Dosing Interval (Ctau) | Total Antibody | 1.1938 ug/mL | Geometric Coefficient of Variation 98.7 |
| BMS-986148 0.4MG/KG QW | Concentration at the End of a Dosing Interval (Ctau) | Unconjugated Tubulysin | 0.1634 ug/mL | Geometric Coefficient of Variation 48.2 |
| BMS-986148 0.4MG/KG QW | Concentration at the End of a Dosing Interval (Ctau) | Active Antibody-Drug Conjugate (ADC) | 0.1558 ug/mL | Geometric Coefficient of Variation 123.4 |
| BMS-986148 0.6MG/KG QW | Concentration at the End of a Dosing Interval (Ctau) | Total Antibody | 3.2035 ug/mL | Geometric Coefficient of Variation 20.2 |
| BMS-986148 0.6MG/KG QW | Concentration at the End of a Dosing Interval (Ctau) | Active Antibody-Drug Conjugate (ADC) | 1.2705 ug/mL | Geometric Coefficient of Variation 39.5 |
| BMS-986148 0.6MG/KG QW | Concentration at the End of a Dosing Interval (Ctau) | Unconjugated Tubulysin | 0.1388 ug/mL | Geometric Coefficient of Variation 36 |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Concentration at the End of a Dosing Interval (Ctau) | Active Antibody-Drug Conjugate (ADC) | 1.9068 ug/mL | Geometric Coefficient of Variation 59.1 |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Concentration at the End of a Dosing Interval (Ctau) | Total Antibody | 3.8872 ug/mL | Geometric Coefficient of Variation 46.1 |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Concentration at the End of a Dosing Interval (Ctau) | Unconjugated Tubulysin | 0.3539 ug/mL | Geometric Coefficient of Variation 75 |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Concentration at the End of a Dosing Interval (Ctau) | Total Antibody | 0.2133 ug/mL | Geometric Coefficient of Variation 114 |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Concentration at the End of a Dosing Interval (Ctau) | Active Antibody-Drug Conjugate (ADC) | 0.1119 ug/mL | Geometric Coefficient of Variation 187.1 |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Concentration at the End of a Dosing Interval (Ctau) | Unconjugated Tubulysin | 0.1330 ug/mL | — |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Concentration at the End of a Dosing Interval (Ctau) | Active Antibody-Drug Conjugate (ADC) | 0.0797 ug/mL | Geometric Coefficient of Variation 103.7 |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Concentration at the End of a Dosing Interval (Ctau) | Total Antibody | 0.7544 ug/mL | Geometric Coefficient of Variation 83.5 |
Secondary
Duration of Response (DoR)
Duration of response is defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
Time frame: Up to 58 months
Population: Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All response evaluable participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BMS-986148 0.1MG/KG Q3W | Duration of Response (DoR) | 29.7 Months |
| BMS-986148 0.2MG/KG Q3W | Duration of Response (DoR) | 8.97 Months |
| BMS-986148 0.4MG/KG Q3W | Duration of Response (DoR) | NA Months |
Secondary
Maximum Observed Serum Concentration (Cmax)
Maximum observed serum concentration (Cmax) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Time frame: PK blood assessed on cycle 1, day 1
Population: All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-986148 0.1MG/KG Q3W | Maximum Observed Serum Concentration (Cmax) | Total Antibody | 2.3 ug/mL | Geometric Coefficient of Variation 31.4 |
| BMS-986148 0.1MG/KG Q3W | Maximum Observed Serum Concentration (Cmax) | Active Antibody-Drug Conjugate (ADC) | 2.0 ug/mL | Geometric Coefficient of Variation 29.8 |
| BMS-986148 0.2MG/KG Q3W | Maximum Observed Serum Concentration (Cmax) | Total Antibody | 2.8 ug/mL | Geometric Coefficient of Variation 7.6 |
| BMS-986148 0.2MG/KG Q3W | Maximum Observed Serum Concentration (Cmax) | Active Antibody-Drug Conjugate (ADC) | 2.2 ug/mL | Geometric Coefficient of Variation 8.2 |
| BMS-986148 0.4MG/KG Q3W | Maximum Observed Serum Concentration (Cmax) | Active Antibody-Drug Conjugate (ADC) | 2.6 ug/mL | Geometric Coefficient of Variation 76.1 |
| BMS-986148 0.4MG/KG Q3W | Maximum Observed Serum Concentration (Cmax) | Total Antibody | 3.3 ug/mL | Geometric Coefficient of Variation 76.7 |
| BMS-986148 0.4MG/KG Q3W | Maximum Observed Serum Concentration (Cmax) | Unconjugated Tubulysin | 0.5 ug/mL | — |
| BMS-986148 0.8MG/KG Q3W | Maximum Observed Serum Concentration (Cmax) | Unconjugated Tubulysin | 0.2 ug/mL | Geometric Coefficient of Variation 17.1 |
| BMS-986148 0.8MG/KG Q3W | Maximum Observed Serum Concentration (Cmax) | Active Antibody-Drug Conjugate (ADC) | 15.8 ug/mL | Geometric Coefficient of Variation 46.4 |
| BMS-986148 0.8MG/KG Q3W | Maximum Observed Serum Concentration (Cmax) | Total Antibody | 16.4 ug/mL | Geometric Coefficient of Variation 47.2 |
| BMS-986148 1.6MG/KG Q3W | Maximum Observed Serum Concentration (Cmax) | Active Antibody-Drug Conjugate (ADC) | 40.0 ug/mL | Geometric Coefficient of Variation 26.3 |
| BMS-986148 1.6MG/KG Q3W | Maximum Observed Serum Concentration (Cmax) | Total Antibody | 39.8 ug/mL | Geometric Coefficient of Variation 24.5 |
| BMS-986148 1.6MG/KG Q3W | Maximum Observed Serum Concentration (Cmax) | Unconjugated Tubulysin | 0.4 ug/mL | Geometric Coefficient of Variation 52.3 |
| BMS-986148 1.2MG/KG Q3W Es | Maximum Observed Serum Concentration (Cmax) | Unconjugated Tubulysin | 0.4 ug/mL | Geometric Coefficient of Variation 70.9 |
| BMS-986148 1.2MG/KG Q3W Es | Maximum Observed Serum Concentration (Cmax) | Total Antibody | 28.5 ug/mL | Geometric Coefficient of Variation 14 |
| BMS-986148 1.2MG/KG Q3W Es | Maximum Observed Serum Concentration (Cmax) | Active Antibody-Drug Conjugate (ADC) | 27.0 ug/mL | Geometric Coefficient of Variation 18.6 |
| BMS-986148 0.4MG/KG QW | Maximum Observed Serum Concentration (Cmax) | Total Antibody | 28.3 ug/mL | Geometric Coefficient of Variation 22.5 |
| BMS-986148 0.4MG/KG QW | Maximum Observed Serum Concentration (Cmax) | Active Antibody-Drug Conjugate (ADC) | 27.5 ug/mL | Geometric Coefficient of Variation 22.6 |
| BMS-986148 0.4MG/KG QW | Maximum Observed Serum Concentration (Cmax) | Unconjugated Tubulysin | 0.3 ug/mL | Geometric Coefficient of Variation 58.2 |
| BMS-986148 0.6MG/KG QW | Maximum Observed Serum Concentration (Cmax) | Unconjugated Tubulysin | 0.1 ug/mL | Geometric Coefficient of Variation 36 |
| BMS-986148 0.6MG/KG QW | Maximum Observed Serum Concentration (Cmax) | Total Antibody | 9.3 ug/mL | Geometric Coefficient of Variation 21.3 |
| BMS-986148 0.6MG/KG QW | Maximum Observed Serum Concentration (Cmax) | Active Antibody-Drug Conjugate (ADC) | 8.8 ug/mL | Geometric Coefficient of Variation 20.3 |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Maximum Observed Serum Concentration (Cmax) | Unconjugated Tubulysin | 0.4 ug/mL | Geometric Coefficient of Variation 75 |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Maximum Observed Serum Concentration (Cmax) | Total Antibody | 14.5 ug/mL | Geometric Coefficient of Variation 22.3 |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Maximum Observed Serum Concentration (Cmax) | Active Antibody-Drug Conjugate (ADC) | 13.6 ug/mL | Geometric Coefficient of Variation 31 |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Maximum Observed Serum Concentration (Cmax) | Total Antibody | 16.7 ug/mL | Geometric Coefficient of Variation 19.7 |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Maximum Observed Serum Concentration (Cmax) | Active Antibody-Drug Conjugate (ADC) | 15.3 ug/mL | Geometric Coefficient of Variation 27.6 |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Maximum Observed Serum Concentration (Cmax) | Unconjugated Tubulysin | 0.2 ug/mL | Geometric Coefficient of Variation 42.5 |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Maximum Observed Serum Concentration (Cmax) | Active Antibody-Drug Conjugate (ADC) | 17.8 ug/mL | Geometric Coefficient of Variation 24.6 |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Maximum Observed Serum Concentration (Cmax) | Total Antibody | 18.8 ug/mL | Geometric Coefficient of Variation 22.4 |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Maximum Observed Serum Concentration (Cmax) | Unconjugated Tubulysin | 0.2 ug/mL | Geometric Coefficient of Variation 42.5 |
Secondary
Number of Participants With Anti-Drug Antibody (ADA)
Number of participants with anti-drug antibody (ADA) status grouped by dose + dose regimen. Data was not collected for this outcome measure.
Time frame: Up to 58 months
Population: All ADA evaluable participants
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Number of Participants With Anti-Drug Antibody (ADA) | ADA positive | — |
| Unknown | Number of Participants With Anti-Drug Antibody (ADA) | ADA negative | — |
Secondary
Objective Response Rate (ORR)
Objective response rate is defined as the total percentage of participants whose best overall response (BOR) is either a complete response or partial response divided by the total percentage of participants who are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes 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.
Time frame: Up to 58 months
Population: Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BMS-986148 0.1MG/KG Q3W | Objective Response Rate (ORR) | 4.0 Percentage of participants |
| BMS-986148 0.2MG/KG Q3W | Objective Response Rate (ORR) | 23.1 Percentage of participants |
| BMS-986148 0.4MG/KG Q3W | Objective Response Rate (ORR) | 9.1 Percentage of participants |
| BMS-986148 0.8MG/KG Q3W | Objective Response Rate (ORR) | 0 Percentage of participants |
| BMS-986148 1.6MG/KG Q3W | Objective Response Rate (ORR) | 0 Percentage of participants |
| BMS-986148 1.2MG/KG Q3W Es | Objective Response Rate (ORR) | 0 Percentage of participants |
| BMS-986148 0.4MG/KG QW | Objective Response Rate (ORR) | 0 Percentage of participants |
| BMS-986148 0.6MG/KG QW | Objective Response Rate (ORR) | 0 Percentage of participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Objective Response Rate (ORR) | 0 Percentage of participants |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Objective Response Rate (ORR) | 0 Percentage of participants |
Secondary
Progression Free Survival (PFS)
Progression Free Survival 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. Progression is defined with at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. Participants who did not progress nor died will be censored on the date of their last tumor assessment. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
Time frame: Up to 58 months
Population: Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BMS-986148 0.1MG/KG Q3W | Progression Free Survival (PFS) | 2.56 Months |
| BMS-986148 0.2MG/KG Q3W | Progression Free Survival (PFS) | 5.19 Months |
| BMS-986148 0.4MG/KG Q3W | Progression Free Survival (PFS) | 2.79 Months |
| BMS-986148 0.8MG/KG Q3W | Progression Free Survival (PFS) | NA Months |
| BMS-986148 1.6MG/KG Q3W | Progression Free Survival (PFS) | 1.64 Months |
| BMS-986148 1.2MG/KG Q3W Es | Progression Free Survival (PFS) | NA Months |
| BMS-986148 0.4MG/KG QW | Progression Free Survival (PFS) | 1.66 Months |
| BMS-986148 0.6MG/KG QW | Progression Free Survival (PFS) | 1.49 Months |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Progression Free Survival (PFS) | NA Months |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Progression Free Survival (PFS) | NA Months |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Progression Free Survival (PFS) | NA Months |
Secondary
Progression Free Survival Rate (PFSR) at Week t
Progression free survival rate is defined as the proportion of participants who remain progression free and surviving at 't' weeks (t=4-12 months). The proportion will be calculated by the product-limit method (Kaplan-Meier estimate) which takes into account censored data. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
Time frame: Total PFS assessed between 4 and 12 months, PFSR at months 4 and 6 to be reported
Population: Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BMS-986148 0.1MG/KG Q3W | Progression Free Survival Rate (PFSR) at Week t | 6 months | 0.30 Proportion of participants |
| BMS-986148 0.1MG/KG Q3W | Progression Free Survival Rate (PFSR) at Week t | 4 months | 0.35 Proportion of participants |
| BMS-986148 0.2MG/KG Q3W | Progression Free Survival Rate (PFSR) at Week t | 4 months | 0.65 Proportion of participants |
| BMS-986148 0.2MG/KG Q3W | Progression Free Survival Rate (PFSR) at Week t | 6 months | 0.47 Proportion of participants |
| BMS-986148 0.4MG/KG Q3W | Progression Free Survival Rate (PFSR) at Week t | 4 months | 0.40 Proportion of participants |
| BMS-986148 0.4MG/KG Q3W | Progression Free Survival Rate (PFSR) at Week t | 6 months | NA Proportion of participants |
| BMS-986148 0.8MG/KG Q3W | Progression Free Survival Rate (PFSR) at Week t | 4 months | NA Proportion of participants |
| BMS-986148 0.8MG/KG Q3W | Progression Free Survival Rate (PFSR) at Week t | 6 months | NA Proportion of participants |
| BMS-986148 1.6MG/KG Q3W | Progression Free Survival Rate (PFSR) at Week t | 4 months | NA Proportion of participants |
| BMS-986148 1.6MG/KG Q3W | Progression Free Survival Rate (PFSR) at Week t | 6 months | NA Proportion of participants |
| BMS-986148 1.2MG/KG Q3W Es | Progression Free Survival Rate (PFSR) at Week t | 6 months | NA Proportion of participants |
| BMS-986148 1.2MG/KG Q3W Es | Progression Free Survival Rate (PFSR) at Week t | 4 months | NA Proportion of participants |
| BMS-986148 0.4MG/KG QW | Progression Free Survival Rate (PFSR) at Week t | 6 months | NA Proportion of participants |
| BMS-986148 0.4MG/KG QW | Progression Free Survival Rate (PFSR) at Week t | 4 months | NA Proportion of participants |
| BMS-986148 0.6MG/KG QW | Progression Free Survival Rate (PFSR) at Week t | 4 months | NA Proportion of participants |
| BMS-986148 0.6MG/KG QW | Progression Free Survival Rate (PFSR) at Week t | 6 months | NA Proportion of participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Progression Free Survival Rate (PFSR) at Week t | 4 months | NA Proportion of participants |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Progression Free Survival Rate (PFSR) at Week t | 6 months | NA Proportion of participants |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Progression Free Survival Rate (PFSR) at Week t | 4 months | NA Proportion of participants |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Progression Free Survival Rate (PFSR) at Week t | 6 months | NA Proportion of participants |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Progression Free Survival Rate (PFSR) at Week t | 4 months | NA Proportion of participants |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Progression Free Survival Rate (PFSR) at Week t | 6 months | NA Proportion of participants |
Secondary
Time of Maximum Observed Serum Concentration (Tmax)
Time of maximum observed serum concentration (Tmax) of BMS-986148 grouped by dose + dose regimen.
Time frame: PK blood assessed on cycle 1, day 1
Population: All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| BMS-986148 0.1MG/KG Q3W | Time of Maximum Observed Serum Concentration (Tmax) | Total Antibody | 2.2 Hours |
| BMS-986148 0.1MG/KG Q3W | Time of Maximum Observed Serum Concentration (Tmax) | Active Antibody-Drug Conjugate (ADC) | 0.2 Hours |
| BMS-986148 0.2MG/KG Q3W | Time of Maximum Observed Serum Concentration (Tmax) | Total Antibody | 2.2 Hours |
| BMS-986148 0.2MG/KG Q3W | Time of Maximum Observed Serum Concentration (Tmax) | Active Antibody-Drug Conjugate (ADC) | 2.2 Hours |
| BMS-986148 0.4MG/KG Q3W | Time of Maximum Observed Serum Concentration (Tmax) | Active Antibody-Drug Conjugate (ADC) | 0.5 Hours |
| BMS-986148 0.4MG/KG Q3W | Time of Maximum Observed Serum Concentration (Tmax) | Total Antibody | 3.9 Hours |
| BMS-986148 0.4MG/KG Q3W | Time of Maximum Observed Serum Concentration (Tmax) | Unconjugated Tubulysin | 25.5 Hours |
| BMS-986148 0.8MG/KG Q3W | Time of Maximum Observed Serum Concentration (Tmax) | Unconjugated Tubulysin | 120.2 Hours |
| BMS-986148 0.8MG/KG Q3W | Time of Maximum Observed Serum Concentration (Tmax) | Active Antibody-Drug Conjugate (ADC) | 2.5 Hours |
| BMS-986148 0.8MG/KG Q3W | Time of Maximum Observed Serum Concentration (Tmax) | Total Antibody | 4.0 Hours |
| BMS-986148 1.6MG/KG Q3W | Time of Maximum Observed Serum Concentration (Tmax) | Active Antibody-Drug Conjugate (ADC) | 1.5 Hours |
| BMS-986148 1.6MG/KG Q3W | Time of Maximum Observed Serum Concentration (Tmax) | Total Antibody | 3.9 Hours |
| BMS-986148 1.6MG/KG Q3W | Time of Maximum Observed Serum Concentration (Tmax) | Unconjugated Tubulysin | 167.3 Hours |
| BMS-986148 1.2MG/KG Q3W Es | Time of Maximum Observed Serum Concentration (Tmax) | Unconjugated Tubulysin | 168.8 Hours |
| BMS-986148 1.2MG/KG Q3W Es | Time of Maximum Observed Serum Concentration (Tmax) | Total Antibody | 4.1 Hours |
| BMS-986148 1.2MG/KG Q3W Es | Time of Maximum Observed Serum Concentration (Tmax) | Active Antibody-Drug Conjugate (ADC) | 3.8 Hours |
| BMS-986148 0.4MG/KG QW | Time of Maximum Observed Serum Concentration (Tmax) | Total Antibody | 4.0 Hours |
| BMS-986148 0.4MG/KG QW | Time of Maximum Observed Serum Concentration (Tmax) | Active Antibody-Drug Conjugate (ADC) | 3.9 Hours |
| BMS-986148 0.4MG/KG QW | Time of Maximum Observed Serum Concentration (Tmax) | Unconjugated Tubulysin | 166.1 Hours |
| BMS-986148 0.6MG/KG QW | Time of Maximum Observed Serum Concentration (Tmax) | Unconjugated Tubulysin | 168.2 Hours |
| BMS-986148 0.6MG/KG QW | Time of Maximum Observed Serum Concentration (Tmax) | Total Antibody | 4.0 Hours |
| BMS-986148 0.6MG/KG QW | Time of Maximum Observed Serum Concentration (Tmax) | Active Antibody-Drug Conjugate (ADC) | 4.0 Hours |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Time of Maximum Observed Serum Concentration (Tmax) | Unconjugated Tubulysin | 166.7 Hours |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Time of Maximum Observed Serum Concentration (Tmax) | Total Antibody | 3.8 Hours |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Time of Maximum Observed Serum Concentration (Tmax) | Active Antibody-Drug Conjugate (ADC) | 3.8 Hours |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Time of Maximum Observed Serum Concentration (Tmax) | Total Antibody | 1.1 Hours |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Time of Maximum Observed Serum Concentration (Tmax) | Active Antibody-Drug Conjugate (ADC) | 1.0 Hours |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Time of Maximum Observed Serum Concentration (Tmax) | Unconjugated Tubulysin | 165.1 Hours |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Time of Maximum Observed Serum Concentration (Tmax) | Active Antibody-Drug Conjugate (ADC) | 4.0 Hours |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Time of Maximum Observed Serum Concentration (Tmax) | Total Antibody | 4.0 Hours |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Time of Maximum Observed Serum Concentration (Tmax) | Unconjugated Tubulysin | 166.5 Hours |
Secondary
Trough Observed Serum Concentration (Ctrough)
Trough observed serum concentration (Ctrough) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Time frame: PK blood assessment include cycle 2-day 1 and cycle 1-day 8
Population: All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-986148 0.1MG/KG Q3W | Trough Observed Serum Concentration (Ctrough) | Active Antibody-Drug Conjugate (ADC) | 0.1 ug/mL | Geometric Coefficient of Variation 0 |
| BMS-986148 0.1MG/KG Q3W | Trough Observed Serum Concentration (Ctrough) | Total Antibody | 0.1 ug/mL | Geometric Coefficient of Variation 0 |
| BMS-986148 0.1MG/KG Q3W | Trough Observed Serum Concentration (Ctrough) | Unconjugated Tubulysin | 0.00005 ug/mL | Geometric Coefficient of Variation 0 |
| BMS-986148 0.2MG/KG Q3W | Trough Observed Serum Concentration (Ctrough) | Active Antibody-Drug Conjugate (ADC) | 0.1 ug/mL | Geometric Coefficient of Variation 0 |
| BMS-986148 0.2MG/KG Q3W | Trough Observed Serum Concentration (Ctrough) | Unconjugated Tubulysin | 0.00005 ug/mL | Geometric Coefficient of Variation 0 |
| BMS-986148 0.2MG/KG Q3W | Trough Observed Serum Concentration (Ctrough) | Total Antibody | 0.1 ug/mL | Geometric Coefficient of Variation 0 |
| BMS-986148 0.4MG/KG Q3W | Trough Observed Serum Concentration (Ctrough) | Unconjugated Tubulysin | 0.00005 ug/mL | Geometric Coefficient of Variation 0 |
| BMS-986148 0.4MG/KG Q3W | Trough Observed Serum Concentration (Ctrough) | Active Antibody-Drug Conjugate (ADC) | 0.1 ug/mL | Geometric Coefficient of Variation 0 |
| BMS-986148 0.4MG/KG Q3W | Trough Observed Serum Concentration (Ctrough) | Total Antibody | 0.1 ug/mL | Geometric Coefficient of Variation 0 |
| BMS-986148 0.8MG/KG Q3W | Trough Observed Serum Concentration (Ctrough) | Active Antibody-Drug Conjugate (ADC) | 0.27671 ug/mL | Geometric Coefficient of Variation 95.3 |
| BMS-986148 0.8MG/KG Q3W | Trough Observed Serum Concentration (Ctrough) | Total Antibody | 0.79676 ug/mL | Geometric Coefficient of Variation 92.4 |
| BMS-986148 0.8MG/KG Q3W | Trough Observed Serum Concentration (Ctrough) | Unconjugated Tubulysin | 0.00005 ug/mL | Geometric Coefficient of Variation 0 |
| BMS-986148 1.6MG/KG Q3W | Trough Observed Serum Concentration (Ctrough) | Unconjugated Tubulysin | 0.00007 ug/mL | Geometric Coefficient of Variation 66.6 |
| BMS-986148 1.6MG/KG Q3W | Trough Observed Serum Concentration (Ctrough) | Total Antibody | 0.92146 ug/mL | Geometric Coefficient of Variation 125.9 |
| BMS-986148 1.6MG/KG Q3W | Trough Observed Serum Concentration (Ctrough) | Active Antibody-Drug Conjugate (ADC) | 0.21835 ug/mL | Geometric Coefficient of Variation 152.7 |
| BMS-986148 1.2MG/KG Q3W Es | Trough Observed Serum Concentration (Ctrough) | Active Antibody-Drug Conjugate (ADC) | 0.36894 ug/mL | Geometric Coefficient of Variation 90.7 |
| BMS-986148 1.2MG/KG Q3W Es | Trough Observed Serum Concentration (Ctrough) | Total Antibody | 1.23291 ug/mL | Geometric Coefficient of Variation 81.7 |
| BMS-986148 1.2MG/KG Q3W Es | Trough Observed Serum Concentration (Ctrough) | Unconjugated Tubulysin | 0.00009 ug/mL | Geometric Coefficient of Variation 127.6 |
| BMS-986148 0.4MG/KG QW | Trough Observed Serum Concentration (Ctrough) | Total Antibody | 1.14568 ug/mL | Geometric Coefficient of Variation 104.4 |
| BMS-986148 0.4MG/KG QW | Trough Observed Serum Concentration (Ctrough) | Active Antibody-Drug Conjugate (ADC) | 0.31524 ug/mL | Geometric Coefficient of Variation 111.4 |
| BMS-986148 0.4MG/KG QW | Trough Observed Serum Concentration (Ctrough) | Unconjugated Tubulysin | 0.00006 ug/mL | Geometric Coefficient of Variation 80.7 |
| BMS-986148 0.6MG/KG QW | Trough Observed Serum Concentration (Ctrough) | Total Antibody | 3.20352 ug/mL | Geometric Coefficient of Variation 20.2 |
| BMS-986148 0.6MG/KG QW | Trough Observed Serum Concentration (Ctrough) | Active Antibody-Drug Conjugate (ADC) | 1.27047 ug/mL | Geometric Coefficient of Variation 39.5 |
| BMS-986148 0.6MG/KG QW | Trough Observed Serum Concentration (Ctrough) | Unconjugated Tubulysin | 0.00006 ug/mL | Geometric Coefficient of Variation 64.7 |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Trough Observed Serum Concentration (Ctrough) | Unconjugated Tubulysin | 0.00018 ug/mL | Geometric Coefficient of Variation 104 |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Trough Observed Serum Concentration (Ctrough) | Total Antibody | 3.88717 ug/mL | Geometric Coefficient of Variation 46.1 |
| BMS-986148 0.8MG/KG Q3W+Nivolumab | Trough Observed Serum Concentration (Ctrough) | Active Antibody-Drug Conjugate (ADC) | 1.90678 ug/mL | Geometric Coefficient of Variation 59.1 |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Trough Observed Serum Concentration (Ctrough) | Total Antibody | 0.33875 ug/mL | Geometric Coefficient of Variation 122.1 |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Trough Observed Serum Concentration (Ctrough) | Unconjugated Tubulysin | 0.00005 ug/mL | Geometric Coefficient of Variation 0 |
| BMS 0.8MG/KG Q3W+Nivolumab Es | Trough Observed Serum Concentration (Ctrough) | Active Antibody-Drug Conjugate (ADC) | 0.18096 ug/mL | Geometric Coefficient of Variation 97.4 |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Trough Observed Serum Concentration (Ctrough) | Unconjugated Tubulysin | 0.00005 ug/mL | Geometric Coefficient of Variation 40.8 |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Trough Observed Serum Concentration (Ctrough) | Total Antibody | 0.77912 ug/mL | Geometric Coefficient of Variation 79.1 |
| BMS 0.8MG/KG Q3W+Nivolumab Ex | Trough Observed Serum Concentration (Ctrough) | Active Antibody-Drug Conjugate (ADC) | 0.24389 ug/mL | Geometric Coefficient of Variation 81 |