Advanced Solid Tumors, Non-small Cell Lung Cancer
Conditions
Keywords
BMS-986442, Nivolumab, Chemotherapy
Brief summary
The purpose of this study is to evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.
Interventions
DRUGPemexetred
Specified dose on specified days
DRUGPaclitaxel
Specified dose on specified days
BIOLOGICALBMS-986442
Specified dose on specified days
BIOLOGICALNivolumab
Specified dose on specified days
DRUGDocetaxel
Specified dose on specified days
DRUGCarboplatin
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Participants must have a life expectancy of at least 3 months at the time of first dose.
Exclusion criteria
* Untreated symptomatic central nervous system metastases or leptomeningeal metastases. * Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts. * Participants with an active, known, or suspected autoimmune disease. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | From first dose to 100 days post last dose (Approximately 6 Months) | Number of Participants with Adverse Events. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. For the reporting of all AEs, including intensity or severity, on case report forms, please follow the definitions in National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5). |
| Number of Participants With Serious Adverse Events | From first dose to 100 days post last dose (Approximately 6 Months) | A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). * Requires inpatient hospitalization or causes prolongation of existing hospitalization |
| Number of Participants With Adverse Events Leading to Discontinuation | From first dose to 100 days post last dose (Approximately 6 Months) | Number of Participants with adverse events leading to discontinuation |
| Number of Participants With Dose Limiting Toxicities | From Cycle 1 day 1 to day 28 (28 Days) | DLTs will be defined based on the incidence, intensity, and duration of the AEs for which no clear alternative cause is identified and will exclude events clearly related to disease progression or intercurrent illness. in addition, the following AEs will be DLTs: * Any death that is not clearly due to the underlying disease or extraneous causes * Any Grade ≥ 3 non-hematological toxicity * Any Grade myocarditis * Any Grade myelitis, encephalitis, myasthenia gravis, or Guillain-Barre syndrome * Grade 4 neutropenia of \> 7 days duration * Grade 4 thrombocytopenia. * Grade 3 thrombocytopenia with clinically significant bleeding. * Febrile neutropenia Any AE that is not clearly due to disease progression or extraneous causes that occurs within the 28-day DLT evaluation window and meets criteria for permanent discontinuation will be considered a DLT. |
| Number of Participants Who Died | From first dose to 100 days post last dose (Approximately 6 Months) | Number of Participants who died |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CMax | On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks) | Maximum observed serum concentration |
| Disease Control Rate (DCR) Per Recist v1.1 by Investigator | From first dose to 100 days post last dose (Approximately 6 Months) | Disease Control Rate (DCR) is defined as the number of treated participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD) (and/or SD \> 6 months), based on investigator assessments divided by the number of all treated participants. |
| Tmax | On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks) | Time of maximum observed serum concentration |
| AUC (Tau) | On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks) | Area under the serum concentration-time curve in 1 dosing interval |
| Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | From first dose to 100 days post last dose (Approximately 6 Months) | Number of participants with BMS-986442 Anti Drug Antibody (ADA) |
| Objective Response Rate (ORR) Per Recist v1.1 by Investigator | From first dose to 100 days post last dose (Approximately 6 Months) | ORR is defined as the number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by Investigator, according to RECIST v1.1 criteria, divided by the number of treated participants. The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. For purposes of analysis, if a participant receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent). |
Countries
Australia, Italy, Poland, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part A: Treatment 1 BMS-986442 20mg + Nivo 360mg QW | 5 |
| Part A: Treatment 2 BMS-986442 60mg + Nivo 360mg QW | 3 |
| Part A: Treatment 3 BMS-986442 200mg + Nivo 360mg QW | 4 |
| Part A: Treatment 4 BMS-986442 600mg + Nivo 360mg QW | 3 |
| Part A: Treatment 5 BMS-986442 1200mg + Nivo 360mg QW | 3 |
| Part B1: Treatment 1 BMS-986442 600mg + Nivo 360mg QW | 7 |
| Part B1: Treatment 2 BMS-986442 1200mg + Nivo 360mg QW | 8 |
| Part B2: Treatment 1 BMS-986442 1200mg + Nivo 360mg QW | 3 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 1 | 0 | 0 | 1 | 2 | 2 |
| Overall Study | Not Reported | 2 | 2 | 0 | 0 | 1 | 1 | 3 | 0 |
| Overall Study | Other Reasons | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 3 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Study terminated by Sponsor | 1 | 0 | 0 | 1 | 0 | 4 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 2 | 1 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Part A: Treatment 1 | Part A: Treatment 2 | Part A: Treatment 3 | Part A: Treatment 4 | Part A: Treatment 5 | Part B1: Treatment 1 | Part B1: Treatment 2 | Part B2: Treatment 1 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 58.4 Years STANDARD_DEVIATION 7.5 | 66.3 Years STANDARD_DEVIATION 1.15 | 66.2 Years STANDARD_DEVIATION 7.41 | 76.3 Years STANDARD_DEVIATION 3.79 | 57.3 Years STANDARD_DEVIATION 9.71 | 65.3 Years STANDARD_DEVIATION 8.86 | 60.1 Years STANDARD_DEVIATION 11.41 | 65.7 Years STANDARD_DEVIATION 1.53 | 63.7 Years STANDARD_DEVIATION 9.13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 3 Participants | 4 Participants | 3 Participants | 3 Participants | 7 Participants | 8 Participants | 2 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 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 |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 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 |
| 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 4 Participants | 3 Participants | 3 Participants | 2 Participants | 1 Participants | 7 Participants | 7 Participants | 2 Participants | 29 Participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 3 Participants | 2 Participants | 3 Participants | 1 Participants | 5 Participants | 0 Participants | 18 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 6 Participants | 3 Participants | 3 Participants | 18 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 |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 5 | 0 / 3 | 3 / 4 | 0 / 3 | 1 / 3 | 1 / 7 | 2 / 8 | 2 / 3 |
| other Total, other adverse events | 5 / 5 | 3 / 3 | 4 / 4 | 3 / 3 | 3 / 3 | 7 / 7 | 7 / 8 | 2 / 3 |
| serious Total, serious adverse events | 3 / 5 | 0 / 3 | 4 / 4 | 2 / 3 | 1 / 3 | 4 / 7 | 6 / 8 | 1 / 3 |
Outcome results
Primary
Number of Participants Who Died
Number of Participants who died
Time frame: From first dose to 100 days post last dose (Approximately 6 Months)
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Treatment 1 | Number of Participants Who Died | 2 Participants |
| Part A: Treatment 2 | Number of Participants Who Died | 0 Participants |
| Part A: Treatment 3 | Number of Participants Who Died | 3 Participants |
| Part A: Treatment 4 | Number of Participants Who Died | 0 Participants |
| Part A: Treatment 5 | Number of Participants Who Died | 1 Participants |
| Part B1: Treatment 1 | Number of Participants Who Died | 1 Participants |
| Part B1: Treatment 2 | Number of Participants Who Died | 2 Participants |
| Part B2: Treatment 1 | Number of Participants Who Died | 2 Participants |
Primary
Number of Participants With Adverse Events
Number of Participants with Adverse Events. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. For the reporting of all AEs, including intensity or severity, on case report forms, please follow the definitions in National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Time frame: From first dose to 100 days post last dose (Approximately 6 Months)
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Treatment 1 | Number of Participants With Adverse Events | 5 Participants |
| Part A: Treatment 2 | Number of Participants With Adverse Events | 3 Participants |
| Part A: Treatment 3 | Number of Participants With Adverse Events | 4 Participants |
| Part A: Treatment 4 | Number of Participants With Adverse Events | 3 Participants |
| Part A: Treatment 5 | Number of Participants With Adverse Events | 3 Participants |
| Part B1: Treatment 1 | Number of Participants With Adverse Events | 7 Participants |
| Part B1: Treatment 2 | Number of Participants With Adverse Events | 8 Participants |
| Part B2: Treatment 1 | Number of Participants With Adverse Events | 3 Participants |
Primary
Number of Participants With Adverse Events Leading to Discontinuation
Number of Participants with adverse events leading to discontinuation
Time frame: From first dose to 100 days post last dose (Approximately 6 Months)
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Treatment 1 | Number of Participants With Adverse Events Leading to Discontinuation | 0 Participants |
| Part A: Treatment 2 | Number of Participants With Adverse Events Leading to Discontinuation | 0 Participants |
| Part A: Treatment 3 | Number of Participants With Adverse Events Leading to Discontinuation | 0 Participants |
| Part A: Treatment 4 | Number of Participants With Adverse Events Leading to Discontinuation | 1 Participants |
| Part A: Treatment 5 | Number of Participants With Adverse Events Leading to Discontinuation | 1 Participants |
| Part B1: Treatment 1 | Number of Participants With Adverse Events Leading to Discontinuation | 0 Participants |
| Part B1: Treatment 2 | Number of Participants With Adverse Events Leading to Discontinuation | 1 Participants |
| Part B2: Treatment 1 | Number of Participants With Adverse Events Leading to Discontinuation | 0 Participants |
Primary
Number of Participants With Dose Limiting Toxicities
DLTs will be defined based on the incidence, intensity, and duration of the AEs for which no clear alternative cause is identified and will exclude events clearly related to disease progression or intercurrent illness. in addition, the following AEs will be DLTs: * Any death that is not clearly due to the underlying disease or extraneous causes * Any Grade ≥ 3 non-hematological toxicity * Any Grade myocarditis * Any Grade myelitis, encephalitis, myasthenia gravis, or Guillain-Barre syndrome * Grade 4 neutropenia of \> 7 days duration * Grade 4 thrombocytopenia. * Grade 3 thrombocytopenia with clinically significant bleeding. * Febrile neutropenia Any AE that is not clearly due to disease progression or extraneous causes that occurs within the 28-day DLT evaluation window and meets criteria for permanent discontinuation will be considered a DLT.
Time frame: From Cycle 1 day 1 to day 28 (28 Days)
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Treatment 1 | Number of Participants With Dose Limiting Toxicities | 0 Participants |
| Part A: Treatment 2 | Number of Participants With Dose Limiting Toxicities | 0 Participants |
| Part A: Treatment 3 | Number of Participants With Dose Limiting Toxicities | 0 Participants |
| Part A: Treatment 4 | Number of Participants With Dose Limiting Toxicities | 0 Participants |
| Part A: Treatment 5 | Number of Participants With Dose Limiting Toxicities | 0 Participants |
| Part B1: Treatment 1 | Number of Participants With Dose Limiting Toxicities | 0 Participants |
| Part B1: Treatment 2 | Number of Participants With Dose Limiting Toxicities | 1 Participants |
| Part B2: Treatment 1 | Number of Participants With Dose Limiting Toxicities | 0 Participants |
Primary
Number of Participants With Serious Adverse Events
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). * Requires inpatient hospitalization or causes prolongation of existing hospitalization
Time frame: From first dose to 100 days post last dose (Approximately 6 Months)
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Treatment 1 | Number of Participants With Serious Adverse Events | 3 Participants |
| Part A: Treatment 2 | Number of Participants With Serious Adverse Events | 0 Participants |
| Part A: Treatment 3 | Number of Participants With Serious Adverse Events | 4 Participants |
| Part A: Treatment 4 | Number of Participants With Serious Adverse Events | 2 Participants |
| Part A: Treatment 5 | Number of Participants With Serious Adverse Events | 1 Participants |
| Part B1: Treatment 1 | Number of Participants With Serious Adverse Events | 4 Participants |
| Part B1: Treatment 2 | Number of Participants With Serious Adverse Events | 6 Participants |
| Part B2: Treatment 1 | Number of Participants With Serious Adverse Events | 1 Participants |
Secondary
AUC (Tau)
Area under the serum concentration-time curve in 1 dosing interval
Time frame: On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
Population: PK evaluable population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Treatment 1 | AUC (Tau) | Cycle 1 Day 1 | 697.89 h*ug/mL | Geometric Coefficient of Variation 22.59 |
| Part A: Treatment 1 | AUC (Tau) | Cycle 4 Day 1 | 650.12 h*ug/mL | Geometric Coefficient of Variation 91.31 |
| Part A: Treatment 2 | AUC (Tau) | Cycle 1 Day 1 | 2182.10 h*ug/mL | Geometric Coefficient of Variation 60.66 |
| Part A: Treatment 2 | AUC (Tau) | Cycle 4 Day 1 | 4048.56 h*ug/mL | — |
| Part A: Treatment 3 | AUC (Tau) | Cycle 1 Day 1 | 10412.98 h*ug/mL | Geometric Coefficient of Variation 19.48 |
| Part A: Treatment 3 | AUC (Tau) | Cycle 4 Day 1 | 6965.42 h*ug/mL | Geometric Coefficient of Variation 24.78 |
| Part A: Treatment 4 | AUC (Tau) | Cycle 4 Day 1 | 42581.54 h*ug/mL | — |
| Part A: Treatment 4 | AUC (Tau) | Cycle 1 Day 1 | 31421.18 h*ug/mL | Geometric Coefficient of Variation 14.61 |
| Part A: Treatment 5 | AUC (Tau) | Cycle 1 Day 1 | 92086.95 h*ug/mL | Geometric Coefficient of Variation 42.72 |
| Part A: Treatment 5 | AUC (Tau) | Cycle 4 Day 1 | 129835.00 h*ug/mL | — |
| Part B1: Treatment 1 | AUC (Tau) | Cycle 1 Day 1 | 23544.68 h*ug/mL | Geometric Coefficient of Variation 21.49 |
| Part B1: Treatment 1 | AUC (Tau) | Cycle 4 Day 1 | 31371.02 h*ug/mL | — |
| Part B1: Treatment 2 | AUC (Tau) | Cycle 4 Day 1 | 42688.89 h*ug/mL | Geometric Coefficient of Variation 19.18 |
| Part B1: Treatment 2 | AUC (Tau) | Cycle 1 Day 1 | 59747.91 h*ug/mL | Geometric Coefficient of Variation 26.15 |
| Part B2: Treatment 1 | AUC (Tau) | Cycle 1 Day 1 | 28983.46 h*ug/mL | Geometric Coefficient of Variation 22.78 |
Secondary
CMax
Maximum observed serum concentration
Time frame: On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
Population: PK evaluable population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Treatment 1 | CMax | Cycle 1 Day 1 | 6.47 ug/mL | Geometric Coefficient of Variation 12.07 |
| Part A: Treatment 1 | CMax | Cycle 4 Day 1 | 7.53 ug/mL | Geometric Coefficient of Variation 13.81 |
| Part A: Treatment 2 | CMax | Cycle 1 Day 1 | 20.66 ug/mL | Geometric Coefficient of Variation 31.27 |
| Part A: Treatment 2 | CMax | Cycle 4 Day 1 | 28.60 ug/mL | — |
| Part A: Treatment 3 | CMax | Cycle 1 Day 1 | 84.64 ug/mL | Geometric Coefficient of Variation 12.9 |
| Part A: Treatment 3 | CMax | Cycle 4 Day 1 | 88.92 ug/mL | Geometric Coefficient of Variation 26.63 |
| Part A: Treatment 4 | CMax | Cycle 4 Day 1 | 239.00 ug/mL | — |
| Part A: Treatment 4 | CMax | Cycle 1 Day 1 | 213.29 ug/mL | Geometric Coefficient of Variation 24.73 |
| Part A: Treatment 5 | CMax | Cycle 1 Day 1 | 607.16 ug/mL | Geometric Coefficient of Variation 30.57 |
| Part A: Treatment 5 | CMax | Cycle 4 Day 1 | 595.00 ug/mL | — |
| Part B1: Treatment 1 | CMax | Cycle 1 Day 1 | 188.17 ug/mL | Geometric Coefficient of Variation 12.48 |
| Part B1: Treatment 1 | CMax | Cycle 4 Day 1 | 161.37 ug/mL | Geometric Coefficient of Variation 20.29 |
| Part B1: Treatment 2 | CMax | Cycle 4 Day 1 | 345.40 ug/mL | Geometric Coefficient of Variation 25.64 |
| Part B1: Treatment 2 | CMax | Cycle 1 Day 1 | 525.77 ug/mL | Geometric Coefficient of Variation 63.12 |
| Part B2: Treatment 1 | CMax | Cycle 1 Day 1 | 278.89 ug/mL | Geometric Coefficient of Variation 9.14 |
Secondary
Disease Control Rate (DCR) Per Recist v1.1 by Investigator
Disease Control Rate (DCR) is defined as the number of treated participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD) (and/or SD \> 6 months), based on investigator assessments divided by the number of all treated participants.
Time frame: From first dose to 100 days post last dose (Approximately 6 Months)
Population: All Treated Participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Treatment 1 | Disease Control Rate (DCR) Per Recist v1.1 by Investigator | 20.0 Percentage of Participants |
| Part A: Treatment 2 | Disease Control Rate (DCR) Per Recist v1.1 by Investigator | 0 Percentage of Participants |
| Part A: Treatment 3 | Disease Control Rate (DCR) Per Recist v1.1 by Investigator | 25.0 Percentage of Participants |
| Part A: Treatment 4 | Disease Control Rate (DCR) Per Recist v1.1 by Investigator | 0 Percentage of Participants |
| Part A: Treatment 5 | Disease Control Rate (DCR) Per Recist v1.1 by Investigator | 66.7 Percentage of Participants |
| Part B1: Treatment 1 | Disease Control Rate (DCR) Per Recist v1.1 by Investigator | 14.3 Percentage of Participants |
| Part B1: Treatment 2 | Disease Control Rate (DCR) Per Recist v1.1 by Investigator | 12.5 Percentage of Participants |
| Part B2: Treatment 1 | Disease Control Rate (DCR) Per Recist v1.1 by Investigator | 33.3 Percentage of Participants |
Secondary
Number of Participants With BMS-986442 Anti Drug Antibody (ADA)
Number of participants with BMS-986442 Anti Drug Antibody (ADA)
Time frame: From first dose to 100 days post last dose (Approximately 6 Months)
Population: All Treated Participants with baseline and at least one post-baseline evaluable ADA assessment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Positive | 0 Participants |
| Part A: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Not PP- Last sample postive | 0 Participants |
| Part A: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | Baseline ADA Positive | 0 Participants |
| Part A: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Negative | 5 Participants |
| Part A: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Persistent Positive | 0 Participants |
| Part A: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | Other Positive | 0 Participants |
| Part A: Treatment 2 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Negative | 2 Participants |
| Part A: Treatment 2 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Positive | 1 Participants |
| Part A: Treatment 2 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | Other Positive | 0 Participants |
| Part A: Treatment 2 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Persistent Positive | 1 Participants |
| Part A: Treatment 2 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Not PP- Last sample postive | 0 Participants |
| Part A: Treatment 2 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | Baseline ADA Positive | 0 Participants |
| Part A: Treatment 3 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | Other Positive | 0 Participants |
| Part A: Treatment 3 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Positive | 1 Participants |
| Part A: Treatment 3 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Not PP- Last sample postive | 1 Participants |
| Part A: Treatment 3 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Persistent Positive | 0 Participants |
| Part A: Treatment 3 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | Baseline ADA Positive | 0 Participants |
| Part A: Treatment 3 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Negative | 3 Participants |
| Part A: Treatment 4 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | Other Positive | 0 Participants |
| Part A: Treatment 4 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Persistent Positive | 0 Participants |
| Part A: Treatment 4 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Not PP- Last sample postive | 0 Participants |
| Part A: Treatment 4 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Negative | 3 Participants |
| Part A: Treatment 4 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | Baseline ADA Positive | 0 Participants |
| Part A: Treatment 4 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Positive | 0 Participants |
| Part A: Treatment 5 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | Baseline ADA Positive | 0 Participants |
| Part A: Treatment 5 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Not PP- Last sample postive | 1 Participants |
| Part A: Treatment 5 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Positive | 1 Participants |
| Part A: Treatment 5 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Negative | 1 Participants |
| Part A: Treatment 5 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | Other Positive | 0 Participants |
| Part A: Treatment 5 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Persistent Positive | 0 Participants |
| Part B1: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | Other Positive | 0 Participants |
| Part B1: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Negative | 6 Participants |
| Part B1: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Not PP- Last sample postive | 1 Participants |
| Part B1: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | Baseline ADA Positive | 0 Participants |
| Part B1: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Persistent Positive | 0 Participants |
| Part B1: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Positive | 1 Participants |
| Part B1: Treatment 2 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | Other Positive | 0 Participants |
| Part B1: Treatment 2 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | Baseline ADA Positive | 0 Participants |
| Part B1: Treatment 2 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Persistent Positive | 1 Participants |
| Part B1: Treatment 2 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Negative | 5 Participants |
| Part B1: Treatment 2 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Positive | 2 Participants |
| Part B1: Treatment 2 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Not PP- Last sample postive | 1 Participants |
| Part B2: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Negative | 2 Participants |
| Part B2: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Positive | 0 Participants |
| Part B2: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | Baseline ADA Positive | 0 Participants |
| Part B2: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Persistent Positive | 0 Participants |
| Part B2: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | ADA Not PP- Last sample postive | 0 Participants |
| Part B2: Treatment 1 | Number of Participants With BMS-986442 Anti Drug Antibody (ADA) | Other Positive | 0 Participants |
Secondary
Objective Response Rate (ORR) Per Recist v1.1 by Investigator
ORR is defined as the number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by Investigator, according to RECIST v1.1 criteria, divided by the number of treated participants. The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. For purposes of analysis, if a participant receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent).
Time frame: From first dose to 100 days post last dose (Approximately 6 Months)
Population: All Treated Participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Treatment 1 | Objective Response Rate (ORR) Per Recist v1.1 by Investigator | 20.0 Percentage of Participants |
| Part A: Treatment 2 | Objective Response Rate (ORR) Per Recist v1.1 by Investigator | 0 Percentage of Participants |
| Part A: Treatment 3 | Objective Response Rate (ORR) Per Recist v1.1 by Investigator | 0 Percentage of Participants |
| Part A: Treatment 4 | Objective Response Rate (ORR) Per Recist v1.1 by Investigator | 0 Percentage of Participants |
| Part A: Treatment 5 | Objective Response Rate (ORR) Per Recist v1.1 by Investigator | 0 Percentage of Participants |
| Part B1: Treatment 1 | Objective Response Rate (ORR) Per Recist v1.1 by Investigator | 0 Percentage of Participants |
| Part B1: Treatment 2 | Objective Response Rate (ORR) Per Recist v1.1 by Investigator | 0 Percentage of Participants |
| Part B2: Treatment 1 | Objective Response Rate (ORR) Per Recist v1.1 by Investigator | 0 Percentage of Participants |
Secondary
Tmax
Time of maximum observed serum concentration
Time frame: On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
Population: PK evaluable population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Treatment 1 | Tmax | Cycle 1 Day 1 | 4.0 hours |
| Part A: Treatment 1 | Tmax | Cycle 4 Day 1 | 1.22 hours |
| Part A: Treatment 2 | Tmax | Cycle 1 Day 1 | 1.17 hours |
| Part A: Treatment 2 | Tmax | Cycle 4 Day 1 | 3.88 hours |
| Part A: Treatment 3 | Tmax | Cycle 1 Day 1 | 1.52 hours |
| Part A: Treatment 3 | Tmax | Cycle 4 Day 1 | 1.23 hours |
| Part A: Treatment 4 | Tmax | Cycle 4 Day 1 | 3.93 hours |
| Part A: Treatment 4 | Tmax | Cycle 1 Day 1 | 1.77 hours |
| Part A: Treatment 5 | Tmax | Cycle 1 Day 1 | 4.05 hours |
| Part A: Treatment 5 | Tmax | Cycle 4 Day 1 | 23.98 hours |
| Part B1: Treatment 1 | Tmax | Cycle 1 Day 1 | 1.27 hours |
| Part B1: Treatment 1 | Tmax | Cycle 4 Day 1 | 13.94 hours |
| Part B1: Treatment 2 | Tmax | Cycle 4 Day 1 | 5.50 hours |
| Part B1: Treatment 2 | Tmax | Cycle 1 Day 1 | 1.67 hours |
| Part B2: Treatment 1 | Tmax | Cycle 1 Day 1 | 1.67 hours |