Trial Outcomes & Findings for A Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine (NCT NCT02545075)

NCT ID: NCT02545075

Last Updated: 2020-05-19

Results Overview

Two-year survival rate is defined as the probability that a subject is alive at 2 years following the randomization date and will be estimated via the Kaplan-Meier (KM) method.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 182 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2020-05-19

Participant Flow

182 participants were enrolled, 68 were not randomized, reasons for not being randomized:3 participants withdrew consent and 65 no longer meet study criteria.

Participant milestones

Measure	Ipilimumab (3 mg/kg) Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)	Dacarbazine (250 mg/m2) DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
Randomization STARTED	122	60
Randomization COMPLETED	122	53
Randomization NOT COMPLETED	0	7
Treatment STARTED	122	53
Treatment COMPLETED	0	0
Treatment NOT COMPLETED	122	53

Reasons for withdrawal

Measure	Ipilimumab (3 mg/kg) Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)	Dacarbazine (250 mg/m2) DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
Randomization Lost to Follow-up	0	1
Randomization Withdrawal by Subject	0	6
Treatment Disease progression	71	32
Treatment Participant dicontinued study treatment	7	9
Treatment Withdrawal by Subject	1	0
Treatment Adverse event not related to study drug	1	0
Treatment Death	1	0
Treatment Participant drug toxicity	1	0
Treatment Completed treatment	40	12

Baseline Characteristics

All randomized participants

Baseline characteristics by cohort

Measure	Ipilimumab (3 mg/kg) n=122 Participants Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)	Dacarbazine (250 mg/m2) n=60 Participants DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.	Total n=182 Participants Total of all reporting groups
Age, Continuous	53.6 years STANDARD_DEVIATION 13.69 • n=5 Participants • All randomized participants	54.3 years STANDARD_DEVIATION 13.39 • n=7 Participants • All randomized participants	53.8 years STANDARD_DEVIATION 13.56 • n=5 Participants • All randomized participants
Sex: Female, Male Female	53 Participants n=5 Participants	26 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	69 Participants n=5 Participants	34 Participants n=7 Participants	103 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	122 Participants n=5 Participants	60 Participants n=7 Participants	182 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	122 Participants n=5 Participants	60 Participants n=7 Participants	182 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: All randomized participants

Two-year survival rate is defined as the probability that a subject is alive at 2 years following the randomization date and will be estimated via the Kaplan-Meier (KM) method.

Outcome measures

Measure	Ipilimumab (3 mg/kg) n=122 Participants Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)	Dacarbazine (250 mg/m2) n=60 Participants DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
Two-Years Survival Rate	33.98 Percentage of Participants Interval 28.36 to 39.67	34.09 Percentage of Participants Interval 25.72 to 42.62

SECONDARY outcome

Timeframe: Approximately 43 months

Population: All randomized participants

Survival rate at 1 year is defined as the probability that a subject is alive at 1 year following the randomization date and will be estimated via the Kaplan-Meier (KM) method.

Outcome measures

Measure	Ipilimumab (3 mg/kg) n=122 Participants Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)	Dacarbazine (250 mg/m2) n=60 Participants DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
One-Year Survival Rate	61.68 Percentage of Participants Interval 55.71 to 67.09	64.11 Percentage of Participants Interval 54.99 to 71.87

SECONDARY outcome

Timeframe: Approximately 43 months

Population: All randomized participants

OS is defined for each subject as the time between randomization date and the date of death (of any cause).

Outcome measures

Measure	Ipilimumab (3 mg/kg) n=122 Participants Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)	Dacarbazine (250 mg/m2) n=60 Participants DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
Overall Survival (OS)	15.08 Months Interval 12.91 to 16.1	14.55 Months Interval 13.37 to 19.19

SECONDARY outcome

Timeframe: Approximately 43 months

Population: All randomized participants

PFS is defined for each subject as the time between randomization date and the date of progression or death, whichever occurs first.

Outcome measures

Measure	Ipilimumab (3 mg/kg) n=122 Participants Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)	Dacarbazine (250 mg/m2) n=60 Participants DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
Progression Free Survival ( PFS)	2.60 Months Interval 2.6 to 2.63	1.84 Months Interval 1.41 to 2.63

SECONDARY outcome

Timeframe: Approximately 43 months

Population: All randomized participants

Primary DCR is defined as the number of subjects in the arm with Best Overall Response (BOR) of complete response (CR), partial response (PR), or stable disease (SD), divided by the total number of randomized subjects in the arm.

Outcome measures

Measure	Ipilimumab (3 mg/kg) n=122 Participants Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)	Dacarbazine (250 mg/m2) n=60 Participants DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
Disease Control Rate ( DCR )	32 Percentage of participants Interval 26.4 to 38.0	31.7 Percentage of participants Interval 23.7 to 40.6

SECONDARY outcome

Timeframe: Approximately 43 months

Population: All randomized participants

BORR definition is defined as the number of subjects in the arm with a BOR of CR or PR, divided by the total number of randomized subjects in the arm.

Outcome measures

Measure	Ipilimumab (3 mg/kg) n=122 Participants Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)	Dacarbazine (250 mg/m2) n=60 Participants DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
Best Overall Response Rate ( BORR )	8.2 Percentage of participants Interval 5.2 to 12.3	8.3 Percentage of participants Interval 4.1 to 14.9

SECONDARY outcome

Timeframe: Approximately 43 months

Population: All randomized participants with response

DoR definition for the response evaluable subjects whose BOR is CR or PR is defined as the time between the date of response of CR or PR (whichever occurs first) and the first date of progressive disease (PD) or the date of death (whichever occurs first).

Outcome measures

Measure	Ipilimumab (3 mg/kg) n=10 Participants Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)	Dacarbazine (250 mg/m2) n=5 Participants DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
Duration of Response ( DoR)	8.99 Months Interval 4.76 to 29.01	7.98 Months Interval 1.45 to Upper limit had not be reached

SECONDARY outcome

Timeframe: Approximately 43 months

Population: All randomized participants with BOR as stable disease

Primary duration of stable disease (DoSD) definition for the randomized subjects whose BOR is SD is defined as the time between the randomization date and the first date of PD or the date of death (whichever occurs first)."

Outcome measures

Measure	Ipilimumab (3 mg/kg) n=29 Participants Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)	Dacarbazine (250 mg/m2) n=14 Participants DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
Duration of Stable Disease ( DoSD )	6.83 Months Interval 5.29 to 7.62	9.40 Months Interval 5.26 to 16.3

Adverse Events

Ipilimumab

Serious events: 34 serious events

Other events: 118 other events

Deaths: 93 deaths

Dacarbazine

Serious events: 12 serious events

Other events: 48 other events

Deaths: 39 deaths

Serious adverse events

Measure	Ipilimumab n=122 participants at risk Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)	Dacarbazine n=53 participants at risk DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
Blood and lymphatic system disorders Anaemia	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	1.9% 1/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	1.9% 1/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Endocrine disorders Hypophysitis	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Endocrine disorders Hypopituitarism	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Gastrointestinal disorders Abdominal pain	1.6% 2/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Gastrointestinal disorders Ascites	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Gastrointestinal disorders Diarrhoea	1.6% 2/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Gastrointestinal disorders Haematemesis	0.00% 0/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	1.9% 1/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
General disorders Oedema peripheral	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
General disorders Pyrexia	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
General disorders Sudden death	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Hepatobiliary disorders Cholecystitis acute	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Immune system disorders Hypersensitivity	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Infections and infestations Cellulitis	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Infections and infestations Skin infection	0.00% 0/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	1.9% 1/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Injury, poisoning and procedural complications Overdose	0.00% 0/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	1.9% 1/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Injury, poisoning and procedural complications Wrist fracture	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Blood bilirubin increased	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	1.9% 1/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	1.9% 1/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	13.1% 16/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	13.2% 7/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Nervous system disorders Cerebral infarction	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	1.9% 1/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Skin and subcutaneous tissue disorders Erythema	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Skin and subcutaneous tissue disorders Rash	1.6% 2/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	1.9% 1/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Vascular disorders Pelvic venous thrombosis	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.

Other adverse events

Measure	Ipilimumab n=122 participants at risk Ipilimumab 3 mg/kg to be administered via intravenous infusion over 90 minutes at Weeks 1, 4, 7 and 10, for a total of four doses in Induction (and Re-Induction for those randomized to the ipilimumab arm who qualify)	Dacarbazine n=53 participants at risk DTIC 250 mg/m2 - Day 1 - 5, to be administered via intravenous infusion at Weeks 1, 4, 7, 10, 13, 16,19, and 22.
Blood and lymphatic system disorders Anaemia	6.6% 8/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	5.7% 3/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	7.5% 4/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Blood and lymphatic system disorders Leukopenia	0.00% 0/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	7.5% 4/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Blood and lymphatic system disorders Neutropenia	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	5.7% 3/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Cardiac disorders Sinus bradycardia	3.3% 4/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	5.7% 3/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Cardiac disorders Supraventricular tachycardia	6.6% 8/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Gastrointestinal disorders Abdominal distension	4.1% 5/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	7.5% 4/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Gastrointestinal disorders Constipation	11.5% 14/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	26.4% 14/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Gastrointestinal disorders Diarrhoea	5.7% 7/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	7.5% 4/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Gastrointestinal disorders Gastrointestinal disorder	3.3% 4/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	15.1% 8/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Gastrointestinal disorders Nausea	14.8% 18/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	41.5% 22/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Gastrointestinal disorders Vomiting	11.5% 14/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	9.4% 5/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
General disorders Asthenia	9.8% 12/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	15.1% 8/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
General disorders Fatigue	9.0% 11/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	11.3% 6/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
General disorders Oedema peripheral	5.7% 7/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	3.8% 2/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
General disorders Pain	12.3% 15/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	11.3% 6/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
General disorders Pyrexia	18.9% 23/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	18.9% 10/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Hepatobiliary disorders Liver injury	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	9.4% 5/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Alanine aminotransferase increased	25.4% 31/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	35.8% 19/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Aspartate aminotransferase increased	18.0% 22/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	32.1% 17/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Bilirubin conjugated increased	7.4% 9/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	9.4% 5/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Blood albumin decreased	12.3% 15/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	9.4% 5/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Blood alkaline phosphatase increased	4.9% 6/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	7.5% 4/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Blood bilirubin increased	11.5% 14/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	9.4% 5/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Blood bilirubin unconjugated increased	5.7% 7/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	1.9% 1/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Blood chloride decreased	5.7% 7/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	9.4% 5/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Blood cholesterol increased	4.9% 6/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	7.5% 4/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Blood glucose increased	8.2% 10/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	9.4% 5/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Blood lactate dehydrogenase increased	23.0% 28/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	5.7% 3/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Blood potassium decreased	0.82% 1/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	5.7% 3/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Blood sodium decreased	7.4% 9/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	11.3% 6/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Blood thyroid stimulating hormone decreased	9.0% 11/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Blood thyroid stimulating hormone increased	22.1% 27/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	7.5% 4/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Blood triglycerides increased	12.3% 15/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	9.4% 5/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Blood uric acid increased	5.7% 7/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	5.7% 3/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Blood urine present	1.6% 2/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	5.7% 3/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations C-reactive protein increased	20.5% 25/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	7.5% 4/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Electrocardiogram T wave abnormal	6.6% 8/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	5.7% 3/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Gamma-glutamyltransferase increased	13.9% 17/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	20.8% 11/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Haemoglobin decreased	18.0% 22/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	11.3% 6/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Lymphocyte count decreased	1.6% 2/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	5.7% 3/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Neutrophil count decreased	4.9% 6/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	15.1% 8/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Neutrophil count increased	13.1% 16/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	3.8% 2/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Neutrophil percentage decreased	5.7% 7/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	1.9% 1/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Neutrophil percentage increased	9.0% 11/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Platelet count decreased	2.5% 3/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	9.4% 5/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Platelet count increased	10.7% 13/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	1.9% 1/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Protein urine present	3.3% 4/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	7.5% 4/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Thyroxine free decreased	5.7% 7/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	1.9% 1/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Thyroxine free increased	6.6% 8/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Tri-iodothyronine decreased	5.7% 7/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Tri-iodothyronine free decreased	7.4% 9/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Tri-iodothyronine free increased	5.7% 7/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations Weight decreased	14.8% 18/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	5.7% 3/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations White blood cell count decreased	5.7% 7/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	28.3% 15/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations White blood cell count increased	17.2% 21/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	11.3% 6/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Investigations White blood cells urine positive	8.2% 10/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	3.8% 2/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Metabolism and nutrition disorders Decreased appetite	22.1% 27/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	32.1% 17/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Metabolism and nutrition disorders Hypokalaemia	4.9% 6/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	9.4% 5/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Metabolism and nutrition disorders Hyponatraemia	4.9% 6/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	7.5% 4/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Musculoskeletal and connective tissue disorders Back pain	4.9% 6/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	5.7% 3/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Musculoskeletal and connective tissue disorders Pain in extremity	6.6% 8/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	1.9% 1/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Nervous system disorders Dizziness	3.3% 4/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	9.4% 5/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Nervous system disorders Headache	6.6% 8/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Psychiatric disorders Insomnia	6.6% 8/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	1.9% 1/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Respiratory, thoracic and mediastinal disorders Cough	10.7% 13/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	7.5% 4/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Skin and subcutaneous tissue disorders Pruritus	22.1% 27/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	3.8% 2/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Skin and subcutaneous tissue disorders Rash	27.0% 33/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	5.7% 3/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.
Vascular disorders Hypertension	5.7% 7/122 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.	0.00% 0/53 • Approximately 43 months Adverse events are reported between first dose and 90 days after last dose of study therapy.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60