Trial Outcomes & Findings for Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma (NCT NCT00084656)
NCT ID: NCT00084656
Last Updated: 2022-04-14
Results Overview
Percentage of participants who experienced an irAE during the course of the study defined by the induction of Grade 1, Grade 2, or acceptable Grade 3 drug-related irAEs. For the purposes of this trial, acceptable drug-related irAEs are skin-related immune-mediated adverse events \< or = Grade 3 (potentially reversible inflammation \< Grade 4 that can be attributable to a local antitumor reaction that could potentially be a therapeutic response will also be considered an acceptable irAE). Note: The confidence interval was calculated using the Clopper Pearson method
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
77 participants
Primary outcome timeframe
Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)
Results posted on
2022-04-14
Participant Flow
77 participants enrolled, 76 treated. 1 not treated due to protocol violation.
Participant milestones
| Measure |
3.0 MG/KG IPILIMUMAB + PEPTIDES
HLA-A\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB + PEPTIDES
HLA-A\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB
HLA-A\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
26
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
25
|
25
|
26
|
Reasons for withdrawal
| Measure |
3.0 MG/KG IPILIMUMAB + PEPTIDES
HLA-A\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB + PEPTIDES
HLA-A\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB
HLA-A\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
|
|---|---|---|---|
|
Overall Study
Other reasons
|
0
|
12
|
11
|
|
Overall Study
Withdrawal by Subject
|
15
|
4
|
4
|
|
Overall Study
Disease relapse
|
0
|
9
|
10
|
|
Overall Study
Disease progression
|
9
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
Baseline Characteristics
Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma
Baseline characteristics by cohort
| Measure |
3.0 MG/KG IPILIMUMAB + PEPTIDES
n=25 Participants
HLA-A\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB + PEPTIDES
n=25 Participants
HLA-A\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB
n=26 Participants
HLA-A\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.7 Years
STANDARD_DEVIATION 15.25 • n=5 Participants
|
53.3 Years
STANDARD_DEVIATION 10.34 • n=7 Participants
|
51.5 Years
STANDARD_DEVIATION 14.06 • n=5 Participants
|
53.1 Years
STANDARD_DEVIATION 13.28 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)Population: All treated participants
Percentage of participants who experienced an irAE during the course of the study defined by the induction of Grade 1, Grade 2, or acceptable Grade 3 drug-related irAEs. For the purposes of this trial, acceptable drug-related irAEs are skin-related immune-mediated adverse events \< or = Grade 3 (potentially reversible inflammation \< Grade 4 that can be attributable to a local antitumor reaction that could potentially be a therapeutic response will also be considered an acceptable irAE). Note: The confidence interval was calculated using the Clopper Pearson method
Outcome measures
| Measure |
3.0 MG/KG IPILIMUMAB + PEPTIDES
n=25 Participants
HLA-A\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB + PEPTIDES
n=25 Participants
HLA-A\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB
n=26 Participants
HLA-A\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
|
|---|---|---|---|
|
Percentage of Participants With Immune-related Adverse Events (irAEs)
|
80.0 Percentage of participants
Interval 62.5 to 91.8
|
72.0 Percentage of participants
Interval 53.8 to 86.1
|
65.4 Percentage of participants
Interval 47.4 to 80.6
|
PRIMARY outcome
Timeframe: up to 3 yearsPopulation: All treated participants for the 10 mg/kg ipilimumab arms of the study only
To determine the time (months) from first dose to disease relapse. Time to disease relapse is defined from the start of treatment to the first occurrence of any new lesion (reported by the investigator on physical exam or diagnostic imaging assessments that are attributed to metastatic melanoma) or death. Participants who neither relapse nor died will be censored on the date of their last tumor evaluation. Median estimated using Kaplan-Meier method; A two-sided 95% CI for median in each treatment group was computed via the log-log transformation method.
Outcome measures
| Measure |
3.0 MG/KG IPILIMUMAB + PEPTIDES
n=25 Participants
HLA-A\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB + PEPTIDES
n=26 Participants
HLA-A\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB
HLA-A\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
|
|---|---|---|---|
|
Time to Disease Relapse
|
NA Months
Interval 10.38 to
insufficient number of events to achieve median value determination and upper limit
|
NA Months
Interval 7.59 to
insufficient number of events to achieve median value determination and upper limit
|
—
|
SECONDARY outcome
Timeframe: Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)Population: All treated participants
The number of participants who experienced a drug-related irAE of any grade over the course of the study. Note: The confidence interval was calculated using the Clopper Pearson method
Outcome measures
| Measure |
3.0 MG/KG IPILIMUMAB + PEPTIDES
n=25 Participants
HLA-A\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB + PEPTIDES
n=25 Participants
HLA-A\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB
n=26 Participants
HLA-A\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
|
|---|---|---|---|
|
Number of Participants With Drug-related irAEs of Any Grade
|
24 Participants
|
24 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: All Treated Subjects with Baseline and at Least one Post-Baseline HAHA Assessment
The secondary objective was to determine the immunologic response to the dosing regimen, via Human Anti-Human Antibody (HAHA) Assessment, displayed by number of participants observed as HAHA positive or negative. Note: If participant had at least one post-baseline HAHA result with increase in titer over pre-study, the participant is counted as HAHA Positive. A participant with all negative post-baseline results is counted as HAHA negative.
Outcome measures
| Measure |
3.0 MG/KG IPILIMUMAB + PEPTIDES
n=24 Participants
HLA-A\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB + PEPTIDES
n=21 Participants
HLA-A\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB
n=21 Participants
HLA-A\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
|
|---|---|---|---|
|
Immunologic Response to the Dose Regimen
HAHA positive at baseline
|
5 Number of participants
|
1 Number of participants
|
0 Number of participants
|
|
Immunologic Response to the Dose Regimen
HAHA positive
|
5 Number of participants
|
2 Number of participants
|
1 Number of participants
|
|
Immunologic Response to the Dose Regimen
HAHA negative
|
19 Number of participants
|
19 Number of participants
|
20 Number of participants
|
SECONDARY outcome
Timeframe: Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)Population: All treated participants
The number of participants who experienced a Hematology-related laboratory abnormality (grade 1-4 and grade 3-4 categories, grade 4 being the worst) during the course of the study. Laboratory tests were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Outcome measures
| Measure |
3.0 MG/KG IPILIMUMAB + PEPTIDES
n=25 Participants
HLA-A\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB + PEPTIDES
n=25 Participants
HLA-A\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB
n=26 Participants
HLA-A\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
|
|---|---|---|---|
|
Number of Participants Experiencing Hematology-related Lab Abnormalities
White blood cells, grade 1-4
|
5 Number of participants
|
1 Number of participants
|
0 Number of participants
|
|
Number of Participants Experiencing Hematology-related Lab Abnormalities
White blood cells, grade 3-4
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants Experiencing Hematology-related Lab Abnormalities
Absolute Neutrophil Count, grade 1-4
|
6 Number of participants
|
2 Number of participants
|
3 Number of participants
|
|
Number of Participants Experiencing Hematology-related Lab Abnormalities
Absolute Neutrophil Count, grade 3-4
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants Experiencing Hematology-related Lab Abnormalities
Platelet Count, grade 1-4
|
4 Number of participants
|
2 Number of participants
|
1 Number of participants
|
|
Number of Participants Experiencing Hematology-related Lab Abnormalities
Platelet Count, grade 3-4
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants Experiencing Hematology-related Lab Abnormalities
Hemoglobin, grade 1-4
|
8 Number of participants
|
10 Number of participants
|
15 Number of participants
|
|
Number of Participants Experiencing Hematology-related Lab Abnormalities
Hemoglobin, grade 3-4
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants Experiencing Hematology-related Lab Abnormalities
Lymphocytes, grade 1-4
|
19 Number of participants
|
15 Number of participants
|
17 Number of participants
|
|
Number of Participants Experiencing Hematology-related Lab Abnormalities
Lymphocytes, grade 3-4
|
1 Number of participants
|
1 Number of participants
|
1 Number of participants
|
SECONDARY outcome
Timeframe: Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)Population: All treated participants
The number of participants who experienced a Serum Chemistry-related laboratory abnormality (grade 1-4 and grade 3-4 categories, grade 4 being the worst) during the course of the study. Laboratory tests were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Outcome measures
| Measure |
3.0 MG/KG IPILIMUMAB + PEPTIDES
n=25 Participants
HLA-A\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB + PEPTIDES
n=25 Participants
HLA-A\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB
n=26 Participants
HLA-A\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
|
|---|---|---|---|
|
Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities
alanine aminotransferase (ALT), grade 1-4
|
5 Number of participants
|
6 Number of participants
|
7 Number of participants
|
|
Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities
alanine aminotransferase (ALT), grade 3-4
|
0 Number of participants
|
1 Number of participants
|
1 Number of participants
|
|
Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities
aspartate aminotransferase (AST), grade 1-4
|
9 Number of participants
|
4 Number of participants
|
7 Number of participants
|
|
Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities
aspartate aminotransferase (AST), grade 3-4
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities
Total Bilirubin, grade 1-4
|
2 Number of participants
|
1 Number of participants
|
1 Number of participants
|
|
Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities
Total Bilirubin, grade 3-4
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities
Alkaline Phosphatase, grade 1-4
|
5 Number of participants
|
0 Number of participants
|
3 Number of participants
|
|
Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities
Alkaline Phosphatase, grade 3-4
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities
Amylase, grade 1-4
|
5 Number of participants
|
7 Number of participants
|
10 Number of participants
|
|
Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities
Amylase, grade 3-4
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities
Lipase, grade 1-4
|
3 Number of participants
|
5 Number of participants
|
10 Number of participants
|
|
Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities
Lipase, grade 3-4
|
2 Number of participants
|
2 Number of participants
|
4 Number of participants
|
|
Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities
Creatinine, grade 1-4
|
3 Number of participants
|
2 Number of participants
|
1 Number of participants
|
|
Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities
Creatinine, grade 3-4
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: All treated participants for the 3 mg/kg ipilimumab arm of the study only
To determine the time (months) from first dose to disease relapse. Time to disease relapse is defined from the start of treatment to the first occurrence of any new lesion (reported by the investigator on physical exam or diagnostic imaging assessments that are attributed to metastatic melanoma) or death. Participants who neither relapse nor died will be censored on the date of their last tumor evaluation. Median estimated using Kaplan-Meier method; A two-sided 95% CI for median in each treatment group was computed via the log-log transformation method.
Outcome measures
| Measure |
3.0 MG/KG IPILIMUMAB + PEPTIDES
n=25 Participants
HLA-A\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB + PEPTIDES
HLA-A\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB
HLA-A\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
|
|---|---|---|---|
|
Time to Disease Relapse
|
NA Months
Interval 15.8 to
insufficient number of events to achieve median value determination and upper limit
|
—
|
—
|
Adverse Events
3.0 MG/KG IPILIMUMAB + PEPTIDES
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
10 MG/KG IPILIMUMAB + PEPTIDES
Serious events: 7 serious events
Other events: 25 other events
Deaths: 0 deaths
10 MG/KG IPILIMUMAB
Serious events: 10 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3.0 MG/KG IPILIMUMAB + PEPTIDES
n=25 participants at risk
HLA-A\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB + PEPTIDES
n=25 participants at risk
HLA-A\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB
n=26 participants at risk
HLA-A\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
|
|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Endocrine disorders
Hypopituitarism
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Colitis
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Ileus
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Megacolon
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Fatigue
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Hernia obstructive
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Injection site reaction
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Pyrexia
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Investigations
Blood corticotrophin decreased
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
Other adverse events
| Measure |
3.0 MG/KG IPILIMUMAB + PEPTIDES
n=25 participants at risk
HLA-A\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB + PEPTIDES
n=25 participants at risk
HLA-A\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
Peptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.
|
10 MG/KG IPILIMUMAB
n=26 participants at risk
HLA-A\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
16.0%
4/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
11.5%
3/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
15.4%
4/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Eye disorders
Dry eye
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Eye disorders
Eye pain
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Eye disorders
Eye pruritus
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Eye disorders
Lacrimation increased
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Eye disorders
Photophobia
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Eye disorders
Vision blurred
|
16.0%
4/25 • From first dose to 70 days post last dose (up to 3 years)
|
16.0%
4/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
32.0%
8/25 • From first dose to 70 days post last dose (up to 3 years)
|
48.0%
12/25 • From first dose to 70 days post last dose (up to 3 years)
|
38.5%
10/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Colitis
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
15.4%
4/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Constipation
|
20.0%
5/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
23.1%
6/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
60.0%
15/25 • From first dose to 70 days post last dose (up to 3 years)
|
64.0%
16/25 • From first dose to 70 days post last dose (up to 3 years)
|
76.9%
20/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Flatulence
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
15.4%
4/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Nausea
|
36.0%
9/25 • From first dose to 70 days post last dose (up to 3 years)
|
36.0%
9/25 • From first dose to 70 days post last dose (up to 3 years)
|
46.2%
12/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
16.0%
4/25 • From first dose to 70 days post last dose (up to 3 years)
|
23.1%
6/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Chills
|
32.0%
8/25 • From first dose to 70 days post last dose (up to 3 years)
|
24.0%
6/25 • From first dose to 70 days post last dose (up to 3 years)
|
30.8%
8/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Face oedema
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Fatigue
|
96.0%
24/25 • From first dose to 70 days post last dose (up to 3 years)
|
76.0%
19/25 • From first dose to 70 days post last dose (up to 3 years)
|
76.9%
20/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Granuloma
|
52.0%
13/25 • From first dose to 70 days post last dose (up to 3 years)
|
84.0%
21/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Influenza like illness
|
56.0%
14/25 • From first dose to 70 days post last dose (up to 3 years)
|
28.0%
7/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Injection site erythema
|
16.0%
4/25 • From first dose to 70 days post last dose (up to 3 years)
|
28.0%
7/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Injection site nodule
|
56.0%
14/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Injection site pain
|
68.0%
17/25 • From first dose to 70 days post last dose (up to 3 years)
|
52.0%
13/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Injection site pruritus
|
32.0%
8/25 • From first dose to 70 days post last dose (up to 3 years)
|
20.0%
5/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Injection site rash
|
20.0%
5/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Injection site reaction
|
100.0%
25/25 • From first dose to 70 days post last dose (up to 3 years)
|
44.0%
11/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Injection site swelling
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Injection site vesicles
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Irritability
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Oedema
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Oedema peripheral
|
36.0%
9/25 • From first dose to 70 days post last dose (up to 3 years)
|
36.0%
9/25 • From first dose to 70 days post last dose (up to 3 years)
|
11.5%
3/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Pain
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
General disorders
Pyrexia
|
48.0%
12/25 • From first dose to 70 days post last dose (up to 3 years)
|
40.0%
10/25 • From first dose to 70 days post last dose (up to 3 years)
|
30.8%
8/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Immune system disorders
Hypersensitivity
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Infections and infestations
Nasopharyngitis
|
24.0%
6/25 • From first dose to 70 days post last dose (up to 3 years)
|
24.0%
6/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Infections and infestations
Sinusitis
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
11.5%
3/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Investigations
Blood corticotrophin decreased
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
11.5%
3/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Investigations
Weight decreased
|
16.0%
4/25 • From first dose to 70 days post last dose (up to 3 years)
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
26.9%
7/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Investigations
Weight increased
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.0%
4/25 • From first dose to 70 days post last dose (up to 3 years)
|
16.0%
4/25 • From first dose to 70 days post last dose (up to 3 years)
|
26.9%
7/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
11.5%
3/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
11.5%
3/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
11.5%
3/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.0%
4/25 • From first dose to 70 days post last dose (up to 3 years)
|
16.0%
4/25 • From first dose to 70 days post last dose (up to 3 years)
|
19.2%
5/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
11.5%
3/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
44.0%
11/25 • From first dose to 70 days post last dose (up to 3 years)
|
16.0%
4/25 • From first dose to 70 days post last dose (up to 3 years)
|
11.5%
3/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
11.5%
3/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Nervous system disorders
Amnesia
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Nervous system disorders
Aphasia
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
19.2%
5/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Nervous system disorders
Dysgeusia
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Nervous system disorders
Headache
|
32.0%
8/25 • From first dose to 70 days post last dose (up to 3 years)
|
52.0%
13/25 • From first dose to 70 days post last dose (up to 3 years)
|
53.8%
14/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Nervous system disorders
Lethargy
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Psychiatric disorders
Anxiety
|
16.0%
4/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Psychiatric disorders
Depression
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
11.5%
3/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Psychiatric disorders
Insomnia
|
16.0%
4/25 • From first dose to 70 days post last dose (up to 3 years)
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
23.1%
6/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
16.0%
4/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
5/25 • From first dose to 70 days post last dose (up to 3 years)
|
20.0%
5/25 • From first dose to 70 days post last dose (up to 3 years)
|
34.6%
9/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
24.0%
6/25 • From first dose to 70 days post last dose (up to 3 years)
|
11.5%
3/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
20.0%
5/25 • From first dose to 70 days post last dose (up to 3 years)
|
15.4%
4/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
15.4%
4/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
16.0%
4/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
44.0%
11/25 • From first dose to 70 days post last dose (up to 3 years)
|
72.0%
18/25 • From first dose to 70 days post last dose (up to 3 years)
|
69.2%
18/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
24.0%
6/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
64.0%
16/25 • From first dose to 70 days post last dose (up to 3 years)
|
68.0%
17/25 • From first dose to 70 days post last dose (up to 3 years)
|
69.2%
18/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
11.5%
3/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Vascular disorders
Hot flush
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
7.7%
2/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Vascular disorders
Hypertension
|
12.0%
3/25 • From first dose to 70 days post last dose (up to 3 years)
|
4.0%
1/25 • From first dose to 70 days post last dose (up to 3 years)
|
3.8%
1/26 • From first dose to 70 days post last dose (up to 3 years)
|
|
Vascular disorders
Varicose vein
|
8.0%
2/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/25 • From first dose to 70 days post last dose (up to 3 years)
|
0.00%
0/26 • From first dose to 70 days post last dose (up to 3 years)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60