An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers

Progression Free Survival in Cohorts 1A, 1B and 2B

PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by investigator or death due to any cause, whichever is earlier.

Time frame: approximately 2.15 Months

Duration of Response by BICR in Cohort 2C

Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by BICR (per RECIST 1.1), or death due to any cause, whichever occurs first.

Time frame: approximately 2.5 Months

PFS by BICR in Cohort 2C

PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier.

Time frame: approximately 2.5 Months

Overall Survival in Cohort 2C

OS is defined as the time from randomization to the time of death due to any cause.

Time frame: approximately 2.5 Months

Objective Response Rate by Investigator in Cohort 2C

The percentage of all treated participants whose BOR is either CR or PR by Investigator per RECIST v1.1.

Time frame: approximately 2.5 Months

Duration of Response by Investigator in Cohort 2C

Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by Investigator (per RECIST 1.1), or death due to any cause, whichever occurs first.

Time frame: approximately 2.5 Months

PFS by Investigator in Cohort 2C

PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by investigator or death due to any cause, whichever is earlier.

Time frame: approximately 2.5 Months

Safety Related Events in Cohort 2C

Safety Related Events in Cohort 2C

Time frame: approximately 6 Months

Dose Limiting Toxicities in Cohort 2C

A DLT is an adverse event or abnormal lab value not related to disease progression, illness, or other medications. The DLT evaluation period is 5 weeks (35 days) for both BMS-986288 monotherapy and combination dose escalation. Toxicities beyond this period will inform final dose decisions. Participants who discontinue due to a DLT or complete the 5-week period after receiving at least 2 doses are considered DLT-evaluable. Those who withdraw early or receive fewer than 2 doses for non-DLT reasons are not evaluable and may be replaced. Participants with dose delays for non-DLT reasons remain evaluable if they receive at least 2 doses within 8 weeks.

Time frame: approximately 5 weeks

Cmax for Cohorts 1A, 1B and 2B

Cmax is defined as maximum plasma concentration of the drug.

Time frame: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact

Tmax for Cohorts 1A, 1B and 2B

Tmax is defined is the time to maximum plasma concentration

Time frame: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact

AUC(0-T) for Cohorts 1A, 1B and 2B

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

Time frame: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact

AUC(Tau) for Cohorts 1A, 1B and 2B

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

Time frame: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact

C(Tau) for Cohorts 1A, 1B and 2B

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

Time frame: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact