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An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab

A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02754141
Enrollment
235
Registered
2016-04-28
Start date
2016-06-21
Completion date
2021-10-12
Last updated
2023-04-05

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

Conditions

Malignant Solid Tumor

Brief summary

The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.

Interventions

BIOLOGICALBMS-986179

Specified dose on specified days

BIOLOGICALNivolumab

Specified dose on specified days

BIOLOGICALrHuPH20

Specified dose on specified days

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Solid cancers that are advanced or have spread (for which alternative therapies were deemed not effective) * Eastern Cooperative Oncology Group (ECOG) 0-1 * Acceptable lab testing results * Allow biopsies

Exclusion criteria

* Central nervous system (CNS) tumors * Uncontrolled or significant cardiovascular diseases * Active or known autoimmune disease * Organ transplant Other protocol defined inclusion/

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.From first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months.Number of participants with drug related adverse events (AE), drug related serious adverse events (SAE), drug related AEs Leading to discontinuation and drug related deaths

Secondary

MeasureTime frameDescription
Percentage of Participants With an Objective Response Rate (ORR) at Week 24from initial treatment to week 24ORR is defined as the percentage of all treated participants whose BOR is either a CR or PR.
Progression Free Survival Rate (PFSR) at Week 24from initial treatment to week 24PFSR at 24 weeks is defined as the percentage of treated participants remaining progression free and surviving at 24 weeks.
Median Duration of Response (DOR)from first measure response approximately up to 25 monthsDOR (computed for all treated subjects with a BOR of CR or PR) is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first.
CmaxPart 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 daysCmax is defined as maximum plasma concentration of the drug
TmaxPart 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 daysTmax is defined is the time to maximum plasma concentration
Number of Participants With a Best Overall Response (BOR) at Week 24from initial treatment to week 24Best overall response (BOR) 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. CR or PR determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met.
AUC (Tau)Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 daysArea under the plasma concentration time-curve. AUC over the dosing interval.
CtauPart 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 daysCtau is defined as the concentration of study drug at the end of the dosing interval
Mean Change From Baseline in CD73 Assaysapproximately up to 95 weeksMean change from baseline in CD73 assays at the end of Part 1A treatment period Assays Measured: EHC CD73 H-score IHC CD73 Cytoplasm H-Score IHC CDS73 Membrane H-Score The H-score is given by the ratio of the weighted sum of the number of positive cells to the total number of detected cells. The H-score captures both the intensity and the proportion of the biomarker of interest from the IHC image and comprises values between 0 and 300. The lower the number equals a better prognosis.
Number of Participants With a Positive Anti-drug Antibody (ADA) Test.From first dose to last dose: Part 1: up to 95 weeks, Part 2 SC: up to 62 weeks, RCC Mono: up to 108 weeks, Part 2: up to 104 weeksA participant with at least one ADA-positive sample relative to baseline at any time after initiation of treatment with BMS-986179 and nivolumab.
AUC (0-T)Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 daysArea under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration

Countries

Australia, Canada, France, Germany, Italy, Netherlands, United States

Participant flow

Pre-assignment details

235 participants treated

Participants by arm

ArmCount
P1A 150mg
BMS-986179 150mg monotherapy leading into BMS-986179 150mg + Nivo 240 combo therapy
14
P1A 300mg
BMS-986179 300mg monotherapy leading into BMS-986179 300mg + Nivo 240mg combo therapy
12
P1A 600mg
BMS-986179 600mg monotherapy leading into BMS-986179 600mg + Nivo 240mg combo therapy
12
P1A 1200mg
BMS-986179 1200mg monotherapy leading into BMS-986179 1200mg + Nivo 240mg combo therapy
9
P1A 1600mg
BMS-986179 1600mg monotherapy leading into BMS-986179 1600mg + Nivo 240mg combo therapy
12
P1B Combo Therapy 150mg
BMS-986179 150mg + Nivo 360mg
9
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
BMS-986179 1200mg + Nivo 360mg
8
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
BMS-986179 1200mg + Nivo 480mg
7
P1B BMS986-179 1600mg
BMS-986179 1600mg SC
18
P2 Combo Pancreatic
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
19
P2 Combo Therapy NSCLC
BMS-986179 600mg Q2W + Nivo 480mg Q4W
31
P2 Combo Melanoma
BMS-986179 600mg Q2W + Nivo 480mg Q4W
15
P2 Combo SCCHN
BMS-986179 600mg Q2W + Nivo 480mg Q4W
15
P2 RCC Mono
BMS-986179 600mg Q2W monotherapy
19
P2 RCC Combo
BMS-986179 600mg Q2W + Nivo 480mg Q4W combo therapy
18
P2 Combo Prostate
BMS-986179 600mg Q2W + Nivo 480mg Q4W
14
P2 Combo Unassiged
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
2
P2 Monotherapy Unassigned
BMS-986179 600mg Q2W
1
Total235

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010FG011FG012FG013FG014FG015FG016FG017
Overall StudyAE unrelated to study drug110132100000000000
Overall StudyCompleted treatment as per protocol010000000000100000
Overall StudyDisease progression117857776111618131012121401
Overall StudyMaximum clinical benefit000100000000000000
Overall StudyNo longer meets study criteria000100000000000000
Overall StudyNot completing monotherapy000000000000010000
Overall StudyOther reasons000000010000200000
Overall StudyRequest to discontinue000000001000011000
Overall StudyStudy drug toxicity110000000021100000
Overall StudyWithdrew consent000000000100000000

Baseline characteristics

CharacteristicTotalP1A 300mgP1A 600mgP1A 1200mgP1A 150mgP1A 1600mgP1B Combo Therapy 150mgP1B Combo Therapy BMS-986179 1200mg + Nivo 360mgP1B Combo Therapy BMS-986179 1200mg + Nivo 480mgP1B BMS986-179 1600mgP2 Combo PancreaticP2 Combo Therapy NSCLCP2 Combo MelanomaP2 Combo SCCHNP2 RCC MonoP2 RCC ComboP2 Combo ProstateP2 Combo UnassigedP2 Monotherapy Unassigned
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
95 Participants3 Participants2 Participants4 Participants7 Participants5 Participants4 Participants1 Participants2 Participants7 Participants5 Participants17 Participants7 Participants9 Participants7 Participants6 Participants9 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
140 Participants9 Participants10 Participants5 Participants7 Participants7 Participants5 Participants7 Participants5 Participants11 Participants14 Participants14 Participants8 Participants6 Participants12 Participants12 Participants5 Participants2 Participants1 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
92 Participants4 Participants6 Participants4 Participants5 Participants5 Participants4 Participants3 Participants7 Participants11 Participants11 Participants1 Participants3 Participants2 Participants12 Participants12 Participants0 Participants2 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
141 Participants7 Participants6 Participants5 Participants9 Participants7 Participants5 Participants5 Participants0 Participants7 Participants8 Participants30 Participants12 Participants12 Participants7 Participants6 Participants14 Participants0 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
8 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants3 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
5 Participants0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
White
218 Participants11 Participants10 Participants8 Participants14 Participants12 Participants8 Participants7 Participants5 Participants14 Participants19 Participants30 Participants15 Participants14 Participants18 Participants18 Participants13 Participants1 Participants1 Participants
Sex: Female, Male
Female
87 Participants5 Participants2 Participants3 Participants8 Participants7 Participants7 Participants4 Participants2 Participants10 Participants8 Participants10 Participants9 Participants1 Participants6 Participants5 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
148 Participants7 Participants10 Participants6 Participants6 Participants5 Participants2 Participants4 Participants5 Participants8 Participants11 Participants21 Participants6 Participants14 Participants13 Participants13 Participants14 Participants2 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
EG012
affected / at risk
EG013
affected / at risk
EG014
affected / at risk
EG015
affected / at risk
EG016
affected / at risk
EG017
affected / at risk
EG018
affected / at risk
EG019
affected / at risk
EG020
affected / at risk
EG021
affected / at risk
EG022
affected / at risk
EG023
affected / at risk
EG024
affected / at risk
EG025
affected / at risk
EG026
affected / at risk
EG027
affected / at risk
EG028
affected / at risk
deaths
Total, all-cause mortality
2 / 141 / 120 / 122 / 92 / 127 / 599 / 1211 / 1111 / 126 / 78 / 1045 / 529 / 98 / 85 / 718 / 1822 / 2414 / 1923 / 3114 / 1513 / 159 / 188 / 191 / 313 / 140 / 11 / 288 / 117155 / 193
other
Total, other adverse events
11 / 148 / 128 / 126 / 912 / 1245 / 5911 / 1211 / 1112 / 127 / 79 / 1050 / 529 / 96 / 86 / 717 / 1821 / 2417 / 1931 / 3114 / 1514 / 1517 / 1819 / 193 / 313 / 141 / 11 / 2110 / 117181 / 193
serious
Total, serious adverse events
3 / 144 / 121 / 122 / 93 / 1213 / 595 / 126 / 119 / 123 / 75 / 1028 / 527 / 97 / 84 / 711 / 1818 / 248 / 1914 / 318 / 1511 / 1511 / 185 / 191 / 34 / 140 / 10 / 257 / 117103 / 193

Outcome results

Primary

Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.

Number of participants with drug related adverse events (AE), drug related serious adverse events (SAE), drug related AEs Leading to discontinuation and drug related deaths

Time frame: From first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months.

Population: All Treated Participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
P1A 150mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P1A 150mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events7 Participants
P1A 150mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events0 Participants
P1A 150mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P1A 300mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P1A 300mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events0 Participants
P1A 300mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P1A 300mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events4 Participants
P1A 600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P1A 600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P1A 600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events0 Participants
P1A 600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events3 Participants
P1A 1200mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events4 Participants
P1A 1200mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events0 Participants
P1A 1200mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P1A 1200mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P1A 1600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events0 Participants
P1A 1600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events5 Participants
P1A 1600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P1A 1600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P1A Combo Therapy 150mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation2 Participants
P1A Combo Therapy 150mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events2 Participants
P1A Combo Therapy 150mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events7 Participants
P1A Combo Therapy 150mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P1A Combo Therapy 300mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events0 Participants
P1A Combo Therapy 300mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events7 Participants
P1A Combo Therapy 300mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P1A Combo Therapy 300mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P1A Combo Therapy 600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P1A Combo Therapy 600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation1 Participants
P1A Combo Therapy 600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events6 Participants
P1A Combo Therapy 600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events1 Participants
P1A Combo Therapy 1200mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P1A Combo Therapy 1200mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events0 Participants
P1A Combo Therapy 1200mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P1A Combo Therapy 1200mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events5 Participants
P1A Combo Therapy 1600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events7 Participants
P1A Combo Therapy 1600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P1A Combo Therapy 1600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P1A Combo Therapy 1600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events1 Participants
P1B Combo Therapy 150mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P1B Combo Therapy 150mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events0 Participants
P1B Combo Therapy 150mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events5 Participants
P1B Combo Therapy 150mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events0 Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events1 Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events2 Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events0 Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P1B BMS986-179 1600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P1B BMS986-179 1600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events4 Participants
P1B BMS986-179 1600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P1B BMS986-179 1600mgNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events0 Participants
P2 Combo PancreaticNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P2 Combo PancreaticNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events0 Participants
P2 Combo PancreaticNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P2 Combo PancreaticNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events11 Participants
P2 Combo Therapy NSCLCNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events1 Participants
P2 Combo Therapy NSCLCNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events21 Participants
P2 Combo Therapy NSCLCNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P2 Combo Therapy NSCLCNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation2 Participants
P2 Combo MelanomaNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P2 Combo MelanomaNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation1 Participants
P2 Combo MelanomaNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events7 Participants
P2 Combo MelanomaNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events1 Participants
P2 Combo SCCHNNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events12 Participants
P2 Combo SCCHNNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events1 Participants
P2 Combo SCCHNNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P2 Combo SCCHNNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation1 Participants
P2 RCC ComboNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P2 RCC ComboNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events1 Participants
P2 RCC ComboNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P2 RCC ComboNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events15 Participants
P2 RCC MonoNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P2 RCC MonoNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events8 Participants
P2 RCC MonoNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P2 RCC MonoNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events0 Participants
P2 Combo RCC CrossoverNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events3 Participants
P2 Combo RCC CrossoverNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P2 Combo RCC CrossoverNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events0 Participants
P2 Combo RCC CrossoverNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P2 Combo ProstateNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P2 Combo ProstateNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events0 Participants
P2 Combo ProstateNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events8 Participants
P2 Combo ProstateNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P2 Monotherapy UnassignedNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events0 Participants
P2 Monotherapy UnassignedNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events0 Participants
P2 Monotherapy UnassignedNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P2 Monotherapy UnassignedNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P2 Combo UnassigedNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Deaths0 Participants
P2 Combo UnassigedNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.AEs Leading to Discontinuation0 Participants
P2 Combo UnassigedNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Adverse Events1 Participants
P2 Combo UnassigedNumber of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.Serious Adverse Events0 Participants
Secondary

AUC (0-T)

Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration

Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days

Population: All Treated Participants with evaluable AUC (0-T) measurements at specified time points

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
P1A 150mgAUC (0-T)Cycle 0 Day 11417.4834 h*ug/mLGeometric Coefficient of Variation 76
P1A 300mgAUC (0-T)Cycle 0 Day 12565.0489 h*ug/mL—
P1A 1200mgAUC (0-T)Cycle 0 Day 19362.9155 h*ug/mLGeometric Coefficient of Variation 39
P1A 1600mgAUC (0-T)Cycle 0 Day 130716.0037 h*ug/mLGeometric Coefficient of Variation 47
P1A Combo Therapy 150mgAUC (0-T)Cycle 0 Day 11225.3679 h*ug/mLGeometric Coefficient of Variation 36
P1A Combo Therapy 150mgAUC (0-T)Cycle 1 Day 223932.5889 h*ug/mLGeometric Coefficient of Variation 44
P1A Combo Therapy 300mgAUC (0-T)Cycle 1 Day 229622.5237 h*ug/mLGeometric Coefficient of Variation 58
P1A Combo Therapy 300mgAUC (0-T)Cycle 0 Day 13418.8393 h*ug/mLGeometric Coefficient of Variation 62
P1A Combo Therapy 600mgAUC (0-T)Cycle 1 Day 2227616.4807 h*ug/mLGeometric Coefficient of Variation 40
P1A Combo Therapy 600mgAUC (0-T)Cycle 0 Day 19139.4853 h*ug/mLGeometric Coefficient of Variation 30
P1A Combo Therapy 1200mgAUC (0-T)Cycle 0 Day 123533.0706 h*ug/mLGeometric Coefficient of Variation 9
P1A Combo Therapy 1200mgAUC (0-T)Cycle 1 Day 2274405.3428 h*ug/mLGeometric Coefficient of Variation 25
P1A Combo Therapy 1600mgAUC (0-T)Cycle 1 Day 2292340.2959 h*ug/mLGeometric Coefficient of Variation 21
P1A Combo Therapy 1600mgAUC (0-T)Cycle 0 Day 131057.8588 h*ug/mLGeometric Coefficient of Variation 26
P1B BMS986-179 1600mgAUC (0-T)Cycle 1 Day 141672.2787 h*ug/mLGeometric Coefficient of Variation 35
P1B BMS986-179 1600mgAUC (0-T)Cycle 2 Day 184384.9379 h*ug/mLGeometric Coefficient of Variation 36
P2 RCC MonoAUC (0-T)Cycle 4 Day 1528348.0936 h*ug/mLGeometric Coefficient of Variation 74
P2 RCC MonoAUC (0-T)Cycle 1 Day 113372.5460 h*ug/mLGeometric Coefficient of Variation 55
Secondary

AUC (Tau)

Area under the plasma concentration time-curve. AUC over the dosing interval.

Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days

Population: All Treated Participants with evaluable AUC (Tau) measurements at specified time points

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
P1A 150mgAUC (Tau)Cycle 0 Day 11417.4834 h*ug/mLGeometric Coefficient of Variation 76
P1A 1600mgAUC (Tau)Cycle 0 Day 134198.6293 h*ug/mLGeometric Coefficient of Variation 33
P1A Combo Therapy 150mgAUC (Tau)Cycle 0 Day 11307.7132 h*ug/mLGeometric Coefficient of Variation 33
P1A Combo Therapy 150mgAUC (Tau)Cycle 1 Day 223975.0900 h*ug/mLGeometric Coefficient of Variation 46
P1A Combo Therapy 300mgAUC (Tau)Cycle 0 Day 13546.1659 h*ug/mLGeometric Coefficient of Variation 59
P1A Combo Therapy 300mgAUC (Tau)Cycle 1 Day 2212326.2351 h*ug/mLGeometric Coefficient of Variation 44
P1A Combo Therapy 600mgAUC (Tau)Cycle 0 Day 19139.4853 h*ug/mLGeometric Coefficient of Variation 30
P1A Combo Therapy 600mgAUC (Tau)Cycle 1 Day 2230044.3813 h*ug/mLGeometric Coefficient of Variation 35
P1A Combo Therapy 1200mgAUC (Tau)Cycle 1 Day 2274405.3428 h*ug/mLGeometric Coefficient of Variation 25
P1A Combo Therapy 1200mgAUC (Tau)Cycle 0 Day 123533.0706 h*ug/mLGeometric Coefficient of Variation 9
P1A Combo Therapy 1600mgAUC (Tau)Cycle 0 Day 134970.3626 h*ug/mLGeometric Coefficient of Variation 12
P1A Combo Therapy 1600mgAUC (Tau)Cycle 1 Day 2292340.2959 h*ug/mLGeometric Coefficient of Variation 21
P1B BMS986-179 1600mgAUC (Tau)Cycle 1 Day 140833.1977 h*ug/mLGeometric Coefficient of Variation 36
P1B BMS986-179 1600mgAUC (Tau)Cycle 2 Day 192770.2634 h*ug/mLGeometric Coefficient of Variation 30
P2 RCC MonoAUC (Tau)Cycle 4 Day 1545391.3244 h*ug/mLGeometric Coefficient of Variation 55
P2 RCC MonoAUC (Tau)Cycle 1 Day 115774.5137 h*ug/mLGeometric Coefficient of Variation 49
Secondary

Cmax

Cmax is defined as maximum plasma concentration of the drug

Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days

Population: All Treated Participants with evaluable cmax measurements at specified time points

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
P1A 150mgCmaxCycle 0 Day 130.6524 ug/mLGeometric Coefficient of Variation 66
P1A 300mgCmaxCycle 0 Day 194.9210 ug/mL—
P1A 1200mgCmaxCycle 0 Day 1218.0423 ug/mLGeometric Coefficient of Variation 8
P1A 1600mgCmaxCycle 0 Day 1499.5178 ug/mLGeometric Coefficient of Variation 10
P1A Combo Therapy 150mgCmaxCycle 0 Day 128.8892 ug/mLGeometric Coefficient of Variation 25
P1A Combo Therapy 150mgCmaxCycle 1 Day 2251.3637 ug/mLGeometric Coefficient of Variation 38
P1A Combo Therapy 300mgCmaxCycle 0 Day 164.3400 ug/mLGeometric Coefficient of Variation 55
P1A Combo Therapy 300mgCmaxCycle 1 Day 2299.3564 ug/mLGeometric Coefficient of Variation 47
P1A Combo Therapy 600mgCmaxCycle 1 Day 22289.8829 ug/mLGeometric Coefficient of Variation 27
P1A Combo Therapy 600mgCmaxCycle 0 Day 1141.3732 ug/mLGeometric Coefficient of Variation 26
P1A Combo Therapy 1200mgCmaxCycle 0 Day 1315.6963 ug/mLGeometric Coefficient of Variation 16
P1A Combo Therapy 1200mgCmaxCycle 1 Day 22722.2768 ug/mLGeometric Coefficient of Variation 32
P1A Combo Therapy 1600mgCmaxCycle 1 Day 22865.8497 ug/mLGeometric Coefficient of Variation 22
P1A Combo Therapy 1600mgCmaxCycle 0 Day 1453.5664 ug/mLGeometric Coefficient of Variation 27
P1B BMS986-179 1600mgCmaxCycle 1 Day 193.7415 ug/mLGeometric Coefficient of Variation 33
P1B BMS986-179 1600mgCmaxCycle 2 Day 1563.4487 ug/mLGeometric Coefficient of Variation 27
P2 RCC MonoCmaxCycle 4 Day 15246.7860 ug/mLGeometric Coefficient of Variation 41
P2 RCC MonoCmaxCycle 1 Day 1142.9541 ug/mLGeometric Coefficient of Variation 37
Secondary

Ctau

Ctau is defined as the concentration of study drug at the end of the dosing interval

Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days

Population: All Treated Participants with evaluable Ctau measurements at specified time points

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
P1A 150mgCtauCycle 0 Day 11.9173 ug/mLGeometric Coefficient of Variation 99
P1A 1600mgCtauCycle 0 Day 182.2225 ug/mLGeometric Coefficient of Variation 82
P1A Combo Therapy 150mgCtauCycle 0 Day 10.8999 ug/mLGeometric Coefficient of Variation 74
P1A Combo Therapy 150mgCtauCycle 1 Day 2214.5545 ug/mLGeometric Coefficient of Variation 54
P1A Combo Therapy 300mgCtauCycle 0 Day 141.0567 ug/mLGeometric Coefficient of Variation 84
P1A Combo Therapy 300mgCtauCycle 1 Day 2251.0567 ug/mLGeometric Coefficient of Variation 44
P1A Combo Therapy 600mgCtauCycle 0 Day 125.9755 ug/mLGeometric Coefficient of Variation 32
P1A Combo Therapy 600mgCtauCycle 1 Day 22126.4960 ug/mLGeometric Coefficient of Variation 37
P1A Combo Therapy 1200mgCtauCycle 1 Day 22366.8165 ug/mLGeometric Coefficient of Variation 21
P1A Combo Therapy 1200mgCtauCycle 0 Day 174.8859 ug/mLGeometric Coefficient of Variation 30
P1A Combo Therapy 1600mgCtauCycle 0 Day 199.0307 ug/mLGeometric Coefficient of Variation 14
P1A Combo Therapy 1600mgCtauCycle 1 Day 22466.5231 ug/mLGeometric Coefficient of Variation 32
P1B BMS986-179 1600mgCtauCycle 1 Day 130.0008 ug/mLGeometric Coefficient of Variation 51
P1B BMS986-179 1600mgCtauCycle 2 Day 152.9049 ug/mLGeometric Coefficient of Variation 71
P2 RCC MonoCtauCycle 4 Day 1598.6089 ug/mLGeometric Coefficient of Variation 76
P2 RCC MonoCtauCycle 1 Day 115.3394 ug/mLGeometric Coefficient of Variation 76
Secondary

Mean Change From Baseline in CD73 Assays

Mean change from baseline in CD73 assays at the end of Part 1A treatment period Assays Measured: EHC CD73 H-score IHC CD73 Cytoplasm H-Score IHC CDS73 Membrane H-Score The H-score is given by the ratio of the weighted sum of the number of positive cells to the total number of detected cells. The H-score captures both the intensity and the proportion of the biomarker of interest from the IHC image and comprises values between 0 and 300. The lower the number equals a better prognosis.

Time frame: approximately up to 95 weeks

Population: All Treated Participants with evaluable CD73 assay measurements for each assay

ArmMeasureGroupValue (MEAN)Dispersion
P1A 150mgMean Change From Baseline in CD73 AssaysEHC CD73 H-Score-33.790 Score on a scaleStandard Error 25.52
P1A 150mgMean Change From Baseline in CD73 AssaysIHC CD73 Membrane H-Score7.3 Score on a scaleStandard Error 6.77
P1A 150mgMean Change From Baseline in CD73 AssaysIHC CD73 Cytoplasm H-Score1.5 Score on a scaleStandard Error 2.6
P1A 300mgMean Change From Baseline in CD73 AssaysIHC CD73 Membrane H-Score8.7 Score on a scaleStandard Error 30.33
P1A 300mgMean Change From Baseline in CD73 AssaysIHC CD73 Cytoplasm H-Score-0.3 Score on a scaleStandard Error 32.04
P1A 300mgMean Change From Baseline in CD73 AssaysEHC CD73 H-Score-103.700 Score on a scaleStandard Error 90.34
P1A 1200mgMean Change From Baseline in CD73 AssaysIHC CD73 Membrane H-Score88.0 Score on a scale—
P1A 1200mgMean Change From Baseline in CD73 AssaysEHC CD73 H-Score-204.710 Score on a scale—
P1A 1200mgMean Change From Baseline in CD73 AssaysIHC CD73 Cytoplasm H-Score17.0 Score on a scale—
P1A 1600mgMean Change From Baseline in CD73 AssaysEHC CD73 H-Score-3.220 Score on a scaleStandard Error 51.78
P1A 1600mgMean Change From Baseline in CD73 AssaysIHC CD73 Cytoplasm H-Score0.0 Score on a scaleStandard Error 0
P1A 1600mgMean Change From Baseline in CD73 AssaysIHC CD73 Membrane H-Score0.00 Score on a scaleStandard Error 0
P1A Combo Therapy 150mgMean Change From Baseline in CD73 AssaysIHC CD73 Cytoplasm H-Score1.5 Score on a scaleStandard Error 2.6
P1A Combo Therapy 150mgMean Change From Baseline in CD73 AssaysEHC CD73 H-Score-33.790 Score on a scaleStandard Error 28.52
P1A Combo Therapy 150mgMean Change From Baseline in CD73 AssaysIHC CD73 Membrane H-Score7.3 Score on a scaleStandard Error 6.77
P1A Combo Therapy 300mgMean Change From Baseline in CD73 AssaysIHC CD73 Cytoplasm H-Score-0.3 Score on a scaleStandard Error 32.04
P1A Combo Therapy 300mgMean Change From Baseline in CD73 AssaysEHC CD73 H-Score-103.700 Score on a scaleStandard Error 90.34
P1A Combo Therapy 300mgMean Change From Baseline in CD73 AssaysIHC CD73 Membrane H-Score8.7 Score on a scaleStandard Error 30.33
P1A Combo Therapy 1200mgMean Change From Baseline in CD73 AssaysIHC CD73 Cytoplasm H-Score17.0 Score on a scale—
P1A Combo Therapy 1200mgMean Change From Baseline in CD73 AssaysEHC CD73 H-Score-204.710 Score on a scale—
P1A Combo Therapy 1200mgMean Change From Baseline in CD73 AssaysIHC CD73 Membrane H-Score88.0 Score on a scale—
P1A Combo Therapy 1600mgMean Change From Baseline in CD73 AssaysEHC CD73 H-Score-3.220 Score on a scaleStandard Error 51.78
P1A Combo Therapy 1600mgMean Change From Baseline in CD73 AssaysIHC CD73 Cytoplasm H-Score0.0 Score on a scaleStandard Error 0
P1A Combo Therapy 1600mgMean Change From Baseline in CD73 AssaysIHC CD73 Membrane H-Score0.0 Score on a scaleStandard Error 0
Secondary

Median Duration of Response (DOR)

DOR (computed for all treated subjects with a BOR of CR or PR) is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first.

Time frame: from first measure response approximately up to 25 months

Population: All Treated Participants with a response

ArmMeasureValue (MEDIAN)
P1A Combo Therapy 150mgMedian Duration of Response (DOR)17.40 Months
P1A Combo Therapy 300mgMedian Duration of Response (DOR)5.70 Months
P1A Combo Therapy 600mgMedian Duration of Response (DOR)9.30 Months
P1A Combo Therapy 1200mgMedian Duration of Response (DOR)2.10 Months
P1A Combo Therapy 1600mgMedian Duration of Response (DOR)24.40 Months
P2 Combo PancreaticMedian Duration of Response (DOR)3.90 Months
P2 Combo Therapy NSCLCMedian Duration of Response (DOR)3.80 Months
P2 Combo SCCHNMedian Duration of Response (DOR)6.70 Months
P2 RCC MonoMedian Duration of Response (DOR)22.90 Months
Secondary

Number of Participants With a Best Overall Response (BOR) at Week 24

Best overall response (BOR) 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. CR or PR determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met.

Time frame: from initial treatment to week 24

Population: All Treated Participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
P1A 150mgNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P1A 150mgNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response0 Participants
P1A 300mgNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response0 Participants
P1A 300mgNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P1A 600mgNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response0 Participants
P1A 600mgNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P1A 1200mgNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P1A 1200mgNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response0 Participants
P1A 1600mgNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P1A 1600mgNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response0 Participants
P1A Combo Therapy 150mgNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P1A Combo Therapy 150mgNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response1 Participants
P1A Combo Therapy 300mgNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response1 Participants
P1A Combo Therapy 300mgNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P1A Combo Therapy 600mgNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response2 Participants
P1A Combo Therapy 600mgNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P1A Combo Therapy 1200mgNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response1 Participants
P1A Combo Therapy 1200mgNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P1A Combo Therapy 1600mgNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response1 Participants
P1A Combo Therapy 1600mgNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P1B Combo Therapy 150mgNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response0 Participants
P1B Combo Therapy 150mgNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mgNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mgNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response0 Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mgNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response0 Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mgNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P1B BMS986-179 1600mgNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P1B BMS986-179 1600mgNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response0 Participants
P2 Combo PancreaticNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P2 Combo PancreaticNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response1 Participants
P2 Combo Therapy NSCLCNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P2 Combo Therapy NSCLCNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response1 Participants
P2 Combo MelanomaNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P2 Combo MelanomaNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response0 Participants
P2 Combo SCCHNNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response1 Participants
P2 Combo SCCHNNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response1 Participants
P2 RCC ComboNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P2 RCC ComboNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response0 Participants
P2 RCC MonoNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response1 Participants
P2 RCC MonoNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P2 Combo RCC CrossoverNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P2 Combo RCC CrossoverNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response0 Participants
P2 Combo ProstateNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response0 Participants
P2 Combo ProstateNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P2 Monotherapy UnassignedNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P2 Monotherapy UnassignedNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response0 Participants
P2 Combo UnassigedNumber of Participants With a Best Overall Response (BOR) at Week 24Complete Response0 Participants
P2 Combo UnassigedNumber of Participants With a Best Overall Response (BOR) at Week 24Partial Response0 Participants
Secondary

Number of Participants With a Positive Anti-drug Antibody (ADA) Test.

A participant with at least one ADA-positive sample relative to baseline at any time after initiation of treatment with BMS-986179 and nivolumab.

Time frame: From first dose to last dose: Part 1: up to 95 weeks, Part 2 SC: up to 62 weeks, RCC Mono: up to 108 weeks, Part 2: up to 104 weeks

Population: All Treated Participants with evaluable ADA measurements

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
P1A 150mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+0 Participants
P1A 150mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+5 Participants
P1A 300mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+1 Participants
P1A 300mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+4 Participants
P1A 600mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+0 Participants
P1A 600mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+8 Participants
P1A 1200mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+0 Participants
P1A 1200mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+3 Participants
P1A 1600mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+2 Participants
P1A 1600mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+0 Participants
P1A Combo Therapy 150mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+1 Participants
P1A Combo Therapy 150mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+5 Participants
P1A Combo Therapy 300mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+6 Participants
P1A Combo Therapy 300mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+1 Participants
P1A Combo Therapy 600mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+5 Participants
P1A Combo Therapy 600mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+0 Participants
P1A Combo Therapy 1200mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+0 Participants
P1A Combo Therapy 1200mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+11 Participants
P1A Combo Therapy 1600mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+2 Participants
P1A Combo Therapy 1600mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+9 Participants
P1B Combo Therapy 150mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+22 Participants
P1B Combo Therapy 150mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+0 Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+0 Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+9 Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+6 Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+0 Participants
P1B BMS986-179 1600mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+14 Participants
P1B BMS986-179 1600mgNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+0 Participants
P2 Combo PancreaticNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+13 Participants
P2 Combo PancreaticNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+0 Participants
P2 Combo Therapy NSCLCNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+2 Participants
P2 Combo Therapy NSCLCNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+0 Participants
P2 Combo MelanomaNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+0 Participants
P2 Combo MelanomaNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+8 Participants
P2 Combo SCCHNNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+0 Participants
P2 Combo SCCHNNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+0 Participants
P2 RCC ComboNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.Nivolumab ADA+0 Participants
P2 RCC ComboNumber of Participants With a Positive Anti-drug Antibody (ADA) Test.BMS-986179 ADA+1 Participants
Secondary

Percentage of Participants With an Objective Response Rate (ORR) at Week 24

ORR is defined as the percentage of all treated participants whose BOR is either a CR or PR.

Time frame: from initial treatment to week 24

Population: All Treated Participants

ArmMeasureValue (NUMBER)
P1A 150mgPercentage of Participants With an Objective Response Rate (ORR) at Week 240 Percentage of Participants
P1A 300mgPercentage of Participants With an Objective Response Rate (ORR) at Week 240 Percentage of Participants
P1A 600mgPercentage of Participants With an Objective Response Rate (ORR) at Week 240 Percentage of Participants
P1A 1200mgPercentage of Participants With an Objective Response Rate (ORR) at Week 240 Percentage of Participants
P1A 1600mgPercentage of Participants With an Objective Response Rate (ORR) at Week 240 Percentage of Participants
P1A Combo Therapy 150mgPercentage of Participants With an Objective Response Rate (ORR) at Week 248.3 Percentage of Participants
P1A Combo Therapy 300mgPercentage of Participants With an Objective Response Rate (ORR) at Week 249.1 Percentage of Participants
P1A Combo Therapy 600mgPercentage of Participants With an Objective Response Rate (ORR) at Week 2416.7 Percentage of Participants
P1A Combo Therapy 1200mgPercentage of Participants With an Objective Response Rate (ORR) at Week 2414.3 Percentage of Participants
P1A Combo Therapy 1600mgPercentage of Participants With an Objective Response Rate (ORR) at Week 2410.0 Percentage of Participants
P1B Combo Therapy 150mgPercentage of Participants With an Objective Response Rate (ORR) at Week 240 Percentage of Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mgPercentage of Participants With an Objective Response Rate (ORR) at Week 240 Percentage of Participants
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mgPercentage of Participants With an Objective Response Rate (ORR) at Week 240 Percentage of Participants
P1B BMS986-179 1600mgPercentage of Participants With an Objective Response Rate (ORR) at Week 240 Percentage of Participants
P2 Combo PancreaticPercentage of Participants With an Objective Response Rate (ORR) at Week 245.3 Percentage of Participants
P2 Combo Therapy NSCLCPercentage of Participants With an Objective Response Rate (ORR) at Week 243.2 Percentage of Participants
P2 Combo MelanomaPercentage of Participants With an Objective Response Rate (ORR) at Week 240 Percentage of Participants
P2 Combo SCCHNPercentage of Participants With an Objective Response Rate (ORR) at Week 2413.3 Percentage of Participants
P2 RCC ComboPercentage of Participants With an Objective Response Rate (ORR) at Week 240 Percentage of Participants
P2 RCC MonoPercentage of Participants With an Objective Response Rate (ORR) at Week 245.3 Percentage of Participants
P2 Combo RCC CrossoverPercentage of Participants With an Objective Response Rate (ORR) at Week 240 Percentage of Participants
P2 Combo ProstatePercentage of Participants With an Objective Response Rate (ORR) at Week 240 Percentage of Participants
P2 Monotherapy UnassignedPercentage of Participants With an Objective Response Rate (ORR) at Week 240 Percentage of Participants
P2 Combo UnassigedPercentage of Participants With an Objective Response Rate (ORR) at Week 240 Percentage of Participants
Secondary

Progression Free Survival Rate (PFSR) at Week 24

PFSR at 24 weeks is defined as the percentage of treated participants remaining progression free and surviving at 24 weeks.

Time frame: from initial treatment to week 24

Population: All Treated Participants

ArmMeasureValue (NUMBER)
P1A 150mgProgression Free Survival Rate (PFSR) at Week 247.1 Percentage
P1A 300mgProgression Free Survival Rate (PFSR) at Week 248.3 Percentage
P1A 600mgProgression Free Survival Rate (PFSR) at Week 240 Percentage
P1A 1200mgProgression Free Survival Rate (PFSR) at Week 2411.1 Percentage
P1A 1600mgProgression Free Survival Rate (PFSR) at Week 2416.7 Percentage
P1A Combo Therapy 150mgProgression Free Survival Rate (PFSR) at Week 2483.3 Percentage
P1A Combo Therapy 300mgProgression Free Survival Rate (PFSR) at Week 2472.7 Percentage
P1A Combo Therapy 600mgProgression Free Survival Rate (PFSR) at Week 2475.0 Percentage
P1A Combo Therapy 1200mgProgression Free Survival Rate (PFSR) at Week 2457.1 Percentage
P1A Combo Therapy 1600mgProgression Free Survival Rate (PFSR) at Week 2470.0 Percentage
P1B Combo Therapy 150mgProgression Free Survival Rate (PFSR) at Week 2488.9 Percentage
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mgProgression Free Survival Rate (PFSR) at Week 2487.5 Percentage
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mgProgression Free Survival Rate (PFSR) at Week 24100.00 Percentage
P1B BMS986-179 1600mgProgression Free Survival Rate (PFSR) at Week 2488.9 Percentage
P2 Combo PancreaticProgression Free Survival Rate (PFSR) at Week 2494.7 Percentage
P2 Combo Therapy NSCLCProgression Free Survival Rate (PFSR) at Week 2471.0 Percentage
P2 Combo MelanomaProgression Free Survival Rate (PFSR) at Week 2486.7 Percentage
P2 Combo SCCHNProgression Free Survival Rate (PFSR) at Week 2480.0 Percentage
P2 RCC ComboProgression Free Survival Rate (PFSR) at Week 2472.2 Percentage
P2 RCC MonoProgression Free Survival Rate (PFSR) at Week 2442.1 Percentage
P2 Combo RCC CrossoverProgression Free Survival Rate (PFSR) at Week 2466.7 Percentage
P2 Combo ProstateProgression Free Survival Rate (PFSR) at Week 2471.4 Percentage
P2 Monotherapy UnassignedProgression Free Survival Rate (PFSR) at Week 24100.0 Percentage
P2 Combo UnassigedProgression Free Survival Rate (PFSR) at Week 2450.0 Percentage
Secondary

Tmax

Tmax is defined is the time to maximum plasma concentration

Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days

Population: All Treated Participants with evaluable tmax measurements at specified time points

ArmMeasureGroupValue (MEDIAN)
P1A 150mgTmaxCycle 0 Day 12.409 hours
P1A 300mgTmaxCycle 0 Day 10.933 hours
P1A 1200mgTmaxCycle 0 Day 12.992 hours
P1A 1600mgTmaxCycle 0 Day 12.700 hours
P1A Combo Therapy 150mgTmaxCycle 0 Day 11.00 hours
P1A Combo Therapy 150mgTmaxCycle 1 Day 224.000 hours
P1A Combo Therapy 300mgTmaxCycle 0 Day 12.942 hours
P1A Combo Therapy 300mgTmaxCycle 1 Day 227.767 hours
P1A Combo Therapy 600mgTmaxCycle 1 Day 224.000 hours
P1A Combo Therapy 600mgTmaxCycle 0 Day 11.109 hours
P1A Combo Therapy 1200mgTmaxCycle 0 Day 14.000 hours
P1A Combo Therapy 1200mgTmaxCycle 1 Day 228.000 hours
P1A Combo Therapy 1600mgTmaxCycle 1 Day 224.000 hours
P1A Combo Therapy 1600mgTmaxCycle 0 Day 13.692 hours
P1B BMS986-179 1600mgTmaxCycle 1 Day 196.200 hours
P1B BMS986-179 1600mgTmaxCycle 2 Day 14.000 hours
P2 RCC MonoTmaxCycle 4 Day 151.275 hours
P2 RCC MonoTmaxCycle 1 Day 14.000 hours

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026