Trial Outcomes & Findings for Nivolumab Combined With BMS-986253 in HCC Patients (NCT NCT04050462)

Last Updated: 2025-10-16

Results Overview

ORR is measured as the percentage of people in a study or treatment group who have a partial response or complete response to the treatment. ORR will be determined based upon RECIST v. 1.1 criteria. Per RECIST v. 1.1 criteria, a Complete Response (CR) is the disappearance of all target lesions, and a Partial Response (PR) is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesions, compared to the baseline.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Every 8 weeks for 1 year and every 3 months thereafter (assessed up to 5 years)

Results posted on

2025-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Nivolumab Monotherapy Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Nivolumab/BMS-986253 Combination Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks: Nivolumab 240 mg IV plus BMS-986253 1200mg IV every 2 weeks Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy
Overall Study STARTED	6	7
Overall Study COMPLETED	5	7
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Nivolumab Monotherapy Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Nivolumab/BMS-986253 Combination Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks: Nivolumab 240 mg IV plus BMS-986253 1200mg IV every 2 weeks Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Nivolumab/Cabiralizumab Combination Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks: Nivolumab 240 mg IV plus Cabiralizumab 4 mg/kg IV every 2 weeks combination therapy Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

Nivolumab Combined With BMS-986253 in HCC Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nivolumab Monotherapy n=6 Participants Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Nivolumab/BMS-986253 Combination n=7 Participants Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks: Nivolumab 240 mg IV plus BMS-986253 1200mg IV every 2 weeks Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Nivolumab/Cabiralizumab Combination Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks: Nivolumab 240 mg IV plus Cabiralizumab 4 mg/kg IV every 2 weeks combination therapy Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Total n=13 Participants Total of all reporting groups
Age, Continuous	72.5 years n=5 Participants	70 years n=7 Participants	—	70 years n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	—	2 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	—	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	—	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	—	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	—	4 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	—	1 Participants n=4 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	—	7 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	—	1 Participants n=4 Participants
Region of Enrollment United States	6 participants n=5 Participants	7 participants n=7 Participants	—	13 participants n=4 Participants

PRIMARY outcome

Timeframe: Every 8 weeks for 1 year and every 3 months thereafter (assessed up to 5 years)

Population: 1 subject on the monotherapy arm withdrew consent after randomization, prior to starting treatment

Outcome measures

Outcome measures
Measure	Nivolumab Monotherapy n=5 Participants Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Nivolumab/BMS-986253 Combination n=7 Participants Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks: Nivolumab 240 mg IV plus BMS-986253 1200mg IV every 2 weeks Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Nivolumab/Cabiralizumab Combination Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks: Nivolumab 240 mg IV plus Cabiralizumab 4 mg/kg IV every 2 weeks combination therapy Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy
Objective Response Rate (ORR)	20 percentage of particpants	28.57 percentage of particpants	—

SECONDARY outcome

Timeframe: From treatment initiation until first sign of response (up to 5 years)

Population: Number of subjects who showed response in each arm were included in analysis.

TTR is the amount of time it takes for a tumor to show a measurable decrease in size or other signs of response after treatment begins

Outcome measures

Outcome measures
Measure	Nivolumab Monotherapy n=1 Participants Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Nivolumab/BMS-986253 Combination n=2 Participants Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks: Nivolumab 240 mg IV plus BMS-986253 1200mg IV every 2 weeks Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Nivolumab/Cabiralizumab Combination Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks: Nivolumab 240 mg IV plus Cabiralizumab 4 mg/kg IV every 2 weeks combination therapy Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy
Time to Response (TTR)	126 days Interval 126.0 to 126.0	116 days Interval 115.0 to 117.0	—

SECONDARY outcome

Timeframe: Through study completion (assessed up to 5 years)

Population: 1 subject on the monotherapy arm withdrew consent after randomization, prior to starting treatment

DOR is the percentage of patients who experience either a complete response (CR), a partial response (PR), or stable disease (SD) to a treatment

Outcome measures

Outcome measures
Measure	Nivolumab Monotherapy n=5 Participants Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Nivolumab/BMS-986253 Combination n=7 Participants Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks: Nivolumab 240 mg IV plus BMS-986253 1200mg IV every 2 weeks Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Nivolumab/Cabiralizumab Combination Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks: Nivolumab 240 mg IV plus Cabiralizumab 4 mg/kg IV every 2 weeks combination therapy Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy
Disease Control Rate (DOR)	80 percentage of participants	57.14 percentage of participants	—

SECONDARY outcome

Timeframe: From date of treatment until the date of first documented progression (assessed up to 5 years)

Population: 1 subject on the monotherapy arm withdrew consent after randomization, prior to starting treatment

PFS is measured as the time from the date of enrollment to disease progression per RECIST v. 1.1 criteria.

Outcome measures

Outcome measures
Measure	Nivolumab Monotherapy n=5 Participants Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Nivolumab/BMS-986253 Combination n=7 Participants Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks: Nivolumab 240 mg IV plus BMS-986253 1200mg IV every 2 weeks Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Nivolumab/Cabiralizumab Combination Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks: Nivolumab 240 mg IV plus Cabiralizumab 4 mg/kg IV every 2 weeks combination therapy Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy
Progression Free Survival (PFS)	191 days Interval 57.0 to 1995.0	171 days Interval 52.0 to 985.0	—

SECONDARY outcome

Timeframe: From date of treatment until the date of death from any cause (assessed up to 5 years)

Population: 1 subject on the monotherapy arm withdrew consent after randomization, prior to starting treatment

OS is the time from treatment start to death of participants.

Outcome measures

Outcome measures
Measure	Nivolumab Monotherapy n=5 Participants Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Nivolumab/BMS-986253 Combination n=7 Participants Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks: Nivolumab 240 mg IV plus BMS-986253 1200mg IV every 2 weeks Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Nivolumab/Cabiralizumab Combination Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks: Nivolumab 240 mg IV plus Cabiralizumab 4 mg/kg IV every 2 weeks combination therapy Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy
Overall Survival (OS)	465 days Interval 145.0 to 1995.0	409 days Interval 127.0 to 1422.0	—

Adverse Events

Nivolumab Monotherapy

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Nivolumab/BMS-986253 Combination

Serious events: 3 serious events

Other events: 7 other events

Deaths: 2 deaths

Nivolumab/Cabiralizumab Combination

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nivolumab Monotherapy n=6 participants at risk Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Nivolumab/BMS-986253 Combination n=7 participants at risk Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks: Nivolumab 240 mg IV plus BMS-986253 1200mg IV every 2 weeks Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy	Nivolumab/Cabiralizumab Combination Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks: Nivolumab 240 mg IV plus Cabiralizumab 4 mg/kg IV every 2 weeks combination therapy Nivolumab 240 mg IV every 2 weeks: Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy
Blood and lymphatic system disorders Anemia	0.00% 0/6 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	14.3% 1/7 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	— 0/0 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.
Investigations Aspartate Aminotransferase Increased	0.00% 0/6 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	14.3% 1/7 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	— 0/0 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 1/6 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	14.3% 1/7 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	— 0/0 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.
Nervous system disorders Encephalopathy	0.00% 0/6 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	14.3% 1/7 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	— 0/0 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.
General disorders Fever	0.00% 0/6 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	14.3% 1/7 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	— 0/0 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.
Gastrointestinal disorders Gastrointestinal Disorders	0.00% 0/6 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	14.3% 1/7 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	— 0/0 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/6 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	14.3% 1/7 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	— 0/0 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.
Vascular disorders Peripheral Ischemia	0.00% 0/6 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	14.3% 1/7 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	— 0/0 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/6 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	14.3% 1/7 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	— 0/0 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.
Skin and subcutaneous tissue disorders Skin Infection	0.00% 0/6 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	14.3% 1/7 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	— 0/0 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.
Vascular disorders Thromboembolic Event	0.00% 0/6 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	14.3% 1/7 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	— 0/0 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.
Gastrointestinal disorders Vomiting	0.00% 0/6 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	14.3% 1/7 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.	— 0/0 • AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months) Treating physicians assess AEs at every office visit; participants are encouraged to call the research team and self-report any AEs in-between visits.

Other adverse events

Additional Information

Nina Beri, MD

NYU Langone Health

Phone: 212-731-5770

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place