Trial Outcomes & Findings for A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer (NCT NCT04075604)

Last Updated: 2022-08-10

Results Overview

The number of participants with dose limiting toxicities (DLTs) during the safety run-in phase. DLTS are defined as treatment emergent adverse events (TEAE) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 that occurs during the first 4 weeks (1 cycle) after treatment. Participants who withdraw from the study during the DLT evaluation period or have received less than 1 dose of nivolumab and 75% of accumulative doses of palbociclib of the cycle for reasons other than a DLT will not be considered as DLT-evaluable participants.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

From first dose to 4 weeks after first dose

Results posted on

2022-08-10

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1: Dose Level 1 Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 1 Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 2 Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)
Overall Study STARTED	2	9	12
Overall Study COMPLETED	1	3	6
Overall Study NOT COMPLETED	1	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Dose Level 1 Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 1 Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 2 Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)
Overall Study Adverse Event	0	0	3
Overall Study Participant request to discontinue study treatment	0	0	1
Overall Study Participant withdrew consent	0	0	1
Overall Study Other reasons	1	0	0
Overall Study Disease progression	0	1	0
Overall Study Study drug toxicity	0	5	1

Baseline Characteristics

A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Dose Level 1 n=2 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 1 n=9 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 2 n=12 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Total n=23 Participants Total of all reporting groups
Age, Continuous	63 Years STANDARD_DEVIATION 2.8 • n=93 Participants	60.3 Years STANDARD_DEVIATION 9.3 • n=4 Participants	67.4 Years STANDARD_DEVIATION 10.2 • n=27 Participants	64.3 Years STANDARD_DEVIATION 9.8 • n=483 Participants
Age, Customized < 65	1 Participants n=93 Participants	7 Participants n=4 Participants	5 Participants n=27 Participants	13 Participants n=483 Participants
Age, Customized >= 65 AND < 75	1 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants	5 Participants n=483 Participants
Age, Customized >= 75 AND < 85	0 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants	5 Participants n=483 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	9 Participants n=4 Participants	12 Participants n=27 Participants	23 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants	4 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=93 Participants	5 Participants n=4 Participants	7 Participants n=27 Participants	14 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	5 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants	9 Participants n=4 Participants	11 Participants n=27 Participants	21 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants

PRIMARY outcome

Timeframe: From first dose to 4 weeks after first dose

Population: All DLT-evaluable participants

Outcome measures

Outcome measures
Measure	Cohort 1: Dose Level 1 n=1 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 1 n=9 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 2 n=12 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)
The Number of Participants With Dose Limiting Toxicities (DLT) in the Safety Run-in Phase	0 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: From randomization phase up to 5 treatment cycles (up to approximately 20 weeks)

Population: All randomized participants in the Randomized phase.

RCB 0-I rate is defined as the percentage of randomized participants who achieve RCB 0: no residual disease or RCB-I: minimal residual disease. RCB is a continuous index combining pathological measurements of primary tumor (size and cellularity) and nodal metastases (number and size) defined by a point system at surgery. No participants continued to the randomized phase; trial was closed after completion of the Safety Run-in.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose up to approximately 6 months after first dose

Population: All Treated Participants in the Safety Run-in Phase

ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per investigator radiographic assessment. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Cohort 1: Dose Level 1 n=2 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 1 n=9 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 2 n=12 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)
Objective Response Rate (ORR)	0.0 Percentage of Participants Interval 0.0 to 84.2	66.7 Percentage of Participants Interval 29.9 to 92.5	75.0 Percentage of Participants Interval 42.8 to 94.5

SECONDARY outcome

Timeframe: From first dose up to approximately 6 months after first dose

Population: All Treated Participants in the Safety Run-In Phase

The percentage of participants who undergo breast conserving surgery (BCS) after completing the study treatments. Confidence interval based on the Clopper and Pearson method.

Outcome measures

Outcome measures
Measure	Cohort 1: Dose Level 1 n=2 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 1 n=9 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 2 n=12 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)
Breast Conserving Surgery (BCS) Rate	50.0 Percentage of Participants Interval 1.3 to 98.7	55.6 Percentage of Participants Interval 21.2 to 86.3	50.0 Percentage of Participants Interval 21.1 to 78.9

SECONDARY outcome

Timeframe: From first dose up to approximately 6 months after first dose

Population: All Treated Participants in the Safety Run-In Phase

The percentage of participants with an absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy. Confidence interval based on the Clopper and Pearson method.

Outcome measures

Outcome measures
Measure	Cohort 1: Dose Level 1 n=2 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 1 n=9 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 2 n=12 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)
Pathological Complete Response (pCR) Rate	0.0 Percentage of Participants Interval 0.0 to 84.2	0.0 Percentage of Participants Interval 0.0 to 33.6	8.3 Percentage of Participants Interval 0.2 to 38.5

SECONDARY outcome

Timeframe: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)

Population: All Treated Participants in the Safety Run-In Phase

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

Outcome measures

Outcome measures
Measure	Cohort 1: Dose Level 1 n=2 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 1 n=9 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 2 n=12 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)
The Number of Participants Experiencing Adverse Events (AEs)	2 Participants	9 Participants	12 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)

Population: All Treated Participants in the Safety Run-In Phase

The number of participants experiencing serious adverse events (SAEs). A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

Outcome measures

Outcome measures
Measure	Cohort 1: Dose Level 1 n=2 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 1 n=9 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 2 n=12 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)
The Number of Participants Experiencing Serious Adverse Events (SAEs)	0 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)

Population: All Treated Participants in the Safety Run-In Phase

The number of participants experiencing adverse events (AEs) that lead to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Dose Level 1 n=2 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 1 n=9 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 2 n=12 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation	0 Participants	5 Participants	4 Participants

SECONDARY outcome

Timeframe: From first dose to 100 days after last dose of study therapy (up to approximately 8 months)

Population: All DLT-evaluable participants in the Safety Run-in Phase

The number of participants experiencing adverse events that are immune-related. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Dose Level 1 n=1 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 1 n=9 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 2 n=12 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)
The Number of Participants Experiencing Immune-Related Adverse Events (AEs) Hyperthyroidism	0 Participants	0 Participants	1 Participants
The Number of Participants Experiencing Immune-Related Adverse Events (AEs) Pneumonitis	0 Participants	0 Participants	1 Participants
The Number of Participants Experiencing Immune-Related Adverse Events (AEs) Rash	0 Participants	2 Participants	0 Participants
The Number of Participants Experiencing Immune-Related Adverse Events (AEs) Hypothyroidism	1 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Immune-Related Adverse Events (AEs) Immune-mediated lung disease	0 Participants	1 Participants	0 Participants
The Number of Participants Experiencing Immune-Related Adverse Events (AEs) Hepatitis	0 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: From first dose up to approximately 8 months

Population: All Treated Participants in the Safety Run-In Phase

The number of participants that have died during the study.

Outcome measures

Outcome measures
Measure	Cohort 1: Dose Level 1 n=2 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 1 n=9 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 2 n=12 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)
The Number of Participants Deaths	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)

Population: All Treated Subjects in Safety Run-in Phase with at Least One On-Treatment TSH measurement

The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal

Outcome measures

Outcome measures
Measure	Cohort 1: Dose Level 1 n=2 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 1 n=9 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 2 n=12 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units TSH > ULN	1 Participants	3 Participants	2 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units TSH > ULN WITH TSH <= ULN AT BASELINE	1 Participants	2 Participants	1 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN	0 Participants	1 Participants	2 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN	0 Participants	2 Participants	2 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units TSH > ULN WITH FT3/FT4 TEST MISSING	1 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units TSH < LLN	0 Participants	3 Participants	4 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units TSH <LLN WITH TSH >= LLN AT BASELINE	0 Participants	2 Participants	4 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN	0 Participants	1 Participants	1 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN	0 Participants	1 Participants	3 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units TSH < LLN WITH FT3/FT4 TEST MISSING	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)

Population: All Treated Participants in the Safety Run-in Phase

The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal

Outcome measures

Outcome measures
Measure	Cohort 1: Dose Level 1 n=2 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 1 n=9 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 2 n=12 Participants Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALT OR AST > 20XULN	0 Participants	1 Participants	2 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALT OR AST > 3XULN	0 Participants	4 Participants	3 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALT OR AST > 5XULN	0 Participants	3 Participants	3 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALT OR AST > 10XULN	0 Participants	2 Participants	2 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests TOTAL BILIRUBIN > 2XULN	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALP > 1.5XULN	0 Participants	3 Participants	1 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 1 DAY	0 Participants	1 Participants	1 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 30 DAYS	0 Participants	1 Participants	1 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS	0 Participants	0 Participants	0 Participants

Adverse Events

Cohort 1: Dose Level 1

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 2: Dose Level 1

Serious events: 5 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort 2: Dose Level 2

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Dose Level 1 n=2 participants at risk Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 1 n=9 participants at risk Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)	Cohort 2: Dose Level 2 n=12 participants at risk Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	11.1% 1/9 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	0.00% 0/12 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/2 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	11.1% 1/9 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	0.00% 0/12 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)
Cardiac disorders Atrial fibrillation	0.00% 0/2 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	11.1% 1/9 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	0.00% 0/12 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)
Hepatobiliary disorders Hepatitis	0.00% 0/2 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	11.1% 1/9 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	0.00% 0/12 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/2 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	0.00% 0/9 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	8.3% 1/12 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)
Investigations Alanine aminotransferase increased	0.00% 0/2 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	11.1% 1/9 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	0.00% 0/12 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)
Investigations Aspartate aminotransferase increased	0.00% 0/2 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	11.1% 1/9 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	0.00% 0/12 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary malignancy	0.00% 0/2 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	0.00% 0/9 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	8.3% 1/12 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	0.00% 0/9 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	8.3% 1/12 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.00% 0/2 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	11.1% 1/9 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	0.00% 0/12 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	11.1% 1/9 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)	0.00% 0/12 • Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)

Other adverse events

Additional Information

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