Trial Outcomes & Findings for Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage lV Malignant Melanoma (NCT NCT01696045)
NCT ID: NCT01696045
Last Updated: 2017-08-29
Results Overview
Overall Survival (OS) was defined as the time from the start of ipilimumab treatment date to death due to any cause. If a participant had not died, the participant was censored at the time of last contact (last known alive date). OS rates at 1 year were calculated from both Kaplan-Meier estimates and the proportion of participants alive at 1 year following start of treatment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
1 year following start of treatment (Assessed up to June 2016, approximately 38 months)
Results posted on
2017-08-29
Participant Flow
14 participants were enrolled in the study. 12 participants received study treatment. 2 participants were enrolled and not treated because they no longer met study criteria.
Participant milestones
| Measure |
Ipilimumab 3mg/kg
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
Ipilimumab 10mg/kg
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
8
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
Ipilimumab 3mg/kg
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
Ipilimumab 10mg/kg
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
|---|---|---|
|
Overall Study
Study drug toxicity
|
1
|
5
|
|
Overall Study
Disease progression
|
2
|
2
|
Baseline Characteristics
Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage lV Malignant Melanoma
Baseline characteristics by cohort
| Measure |
Ipilimumab 3mg/kg
n=4 Participants
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
Ipilimumab 10mg/kg
n=8 Participants
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.3 years
STANDARD_DEVIATION 1.89 • n=5 Participants
|
14.9 years
STANDARD_DEVIATION 0.64 • n=7 Participants
|
14.3 years
STANDARD_DEVIATION 1.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 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: 1 year following start of treatment (Assessed up to June 2016, approximately 38 months)Population: All treated participants
Overall Survival (OS) was defined as the time from the start of ipilimumab treatment date to death due to any cause. If a participant had not died, the participant was censored at the time of last contact (last known alive date). OS rates at 1 year were calculated from both Kaplan-Meier estimates and the proportion of participants alive at 1 year following start of treatment.
Outcome measures
| Measure |
Ipilimumab 3mg/kg
n=4 Participants
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
Ipilimumab 10mg/kg
n=8 Participants
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
|---|---|---|
|
Overall Survival (OS) Rate at 1 Year
OS Rate (Kaplan-Meier estimates)
|
75.0 percentage of participants
Interval 12.8 to 96.1
|
62.5 percentage of participants
Interval 22.9 to 86.1
|
|
Overall Survival (OS) Rate at 1 Year
OS Rate (Proportion of surviving participants)
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
PRIMARY outcome
Timeframe: From first dose to 90 days after last dose (Assessed up to June 2016, approximately 38 months)Population: All treated participants
The percentage of participants with severe Immune-mediated Adverse Reactions (imARs) was determined by dividing the number of participants with grade 3 or worse imARs by the total number of treated participants and expressing this number as a percentage. imARs were AEs determined by the investigator to have an immune-mediated etiology, including inflammatory events associated with ipilimumab treatment.
Outcome measures
| Measure |
Ipilimumab 3mg/kg
n=4 Participants
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
Ipilimumab 10mg/kg
n=8 Participants
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
|---|---|---|
|
Percentage of Participants With Severe Immune-Mediated Adverse Reactions (imARs)
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
SECONDARY outcome
Timeframe: From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)Population: All treated participants
Disease control rate was defined as the percentage of all treated participants with a best overall response of Complete Response (CR), Partial Response (PR), or Stable disease (SD), based on the investigator's assessment per mWHO Criteria. CR= Complete disappearance of all non-index lesions. PR= Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions. SD= Does not meet criteria for complete or partial response, in the absence of progressive disease. PD= At least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s).
Outcome measures
| Measure |
Ipilimumab 3mg/kg
n=4 Participants
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
Ipilimumab 10mg/kg
n=8 Participants
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
25.0 Percentage of participants
Interval 0.6 to 80.6
|
37.5 Percentage of participants
Interval 8.5 to 75.5
|
SECONDARY outcome
Timeframe: From date of first treatment until disease progression or death (Assessed up to June 2016, approximately 38 months)Population: All treated participants
Progression-Free Survival was defined as the time from the start of ipilimumab treatment to disease progression or death, whichever occurs first. A participant who died without reported progression was considered to have progressed on their date of death. For participants who remained alive and had not progressed, PFS was censored on the date of the last tumor assessment.
Outcome measures
| Measure |
Ipilimumab 3mg/kg
n=4 Participants
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
Ipilimumab 10mg/kg
n=8 Participants
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
|---|---|---|
|
Progression Free Survival
|
2.6 months
Interval 2.3 to 8.5
|
2.9 months
Interval 0.7 to
Upper 95% CI value was not reached
|
SECONDARY outcome
Timeframe: From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)Population: All treated participants
Best Overall Response Rate (BORR) was defined as the total number of participants with the best overall response of Complete Response (CR) or Partial Response (PR) divided by the total number of treated participants and expressed as a percentage. CR= Complete disappearance of all non-index lesions. PR= Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions. SD= Does not meet criteria for complete or partial response, in the absence of progressive disease. PD= At least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s).
Outcome measures
| Measure |
Ipilimumab 3mg/kg
n=4 Participants
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
Ipilimumab 10mg/kg
n=8 Participants
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
|---|---|---|
|
Best Overall Response Rate (BORR)
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
SECONDARY outcome
Timeframe: From date of first treatment to date of death (Assessed up to June 2016, approximately 38 months)Population: All treated participants
Overall Survival time was defined as the time from the start of ipilimumab treatment date to date of death due to any cause. Participants who had not died were censored at the time of last contact (last known alive date).
Outcome measures
| Measure |
Ipilimumab 3mg/kg
n=4 Participants
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
Ipilimumab 10mg/kg
n=8 Participants
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
|---|---|---|
|
Overall Survival Time
|
18.2 months
Interval 8.9 to 18.2
|
NA months
Interval 5.2 to
Median and upper 95% CI values were not reached
|
Adverse Events
IPILIMUMAB 3 MG/KG
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
IPILIMUMAB 10 MG/KG
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IPILIMUMAB 3 MG/KG
n=4 participants at risk
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
IPILIMUMAB 10 MG/KG
n=8 participants at risk
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Hepatobiliary disorders
Hepatitis
|
25.0%
1/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
25.0%
2/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
Other adverse events
| Measure |
IPILIMUMAB 3 MG/KG
n=4 participants at risk
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
IPILIMUMAB 10 MG/KG
n=8 participants at risk
Ipilimumab was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Eye disorders
Eyelid pain
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Eye disorders
Photophobia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
25.0%
2/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
37.5%
3/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
50.0%
4/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
75.0%
6/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
87.5%
7/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
General disorders
Asthenia
|
25.0%
1/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
0.00%
0/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
General disorders
Axillary pain
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
General disorders
Chest pain
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
General disorders
Chills
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
General disorders
Fatigue
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
50.0%
4/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
General disorders
Pain
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
General disorders
Pyrexia
|
25.0%
1/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
37.5%
3/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Hepatobiliary disorders
Hepatitis
|
25.0%
1/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
0.00%
0/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Immune system disorders
Drug hypersensitivity
|
25.0%
1/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
0.00%
0/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Immune system disorders
Hypersensitivity
|
25.0%
1/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
0.00%
0/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Infections and infestations
Candida nappy rash
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Infections and infestations
Conjunctivitis
|
25.0%
1/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
0.00%
0/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Infections and infestations
Infection
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
25.0%
2/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
Amylase increased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
25.0%
2/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
Blood albumin decreased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
Blood calcium decreased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
Blood glucose increased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
Blood sodium decreased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
Coagulation factor increased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
Lipase increased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
Weight decreased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
50.0%
4/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Investigations
White blood cell count increased
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
50.0%
4/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
25.0%
2/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
25.0%
2/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
25.0%
2/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
37.5%
3/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
25.0%
2/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
62.5%
5/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
25.0%
2/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
25.0%
2/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
0.00%
0/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
25.0%
2/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
25.0%
2/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
25.0%
2/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
37.5%
3/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
12.5%
1/8 • From date of first dose to 90 days after date of last dose, assessed up to study completion (approximately 38 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER