Trial Outcomes & Findings for Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin (NCT NCT02279732)
NCT ID: NCT02279732
Last Updated: 2019-08-28
Results Overview
OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
342 participants
Primary outcome timeframe
Approximately 43 months post study start
Results posted on
2019-08-28
Participant Flow
342 participants enrolled, 295 were randomized to ipilimumab (148) and placebo arms (147). After chemotherapy, double blinded study treatment, which was the focus of the study, was started.Of all randomized participants, only 98 (ipilimumab arm) and 106 (placebo arm) participants received at least one dose of blinded study therapy.
Participant milestones
| Measure |
Ipi + PAC/CAR
Ipilumumab + paclitaxel/Carboplatin
|
Placebo + PAC/CAR
Placebo + Carboplatin/Paclitaxel
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
106
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
98
|
106
|
Reasons for withdrawal
| Measure |
Ipi + PAC/CAR
Ipilumumab + paclitaxel/Carboplatin
|
Placebo + PAC/CAR
Placebo + Carboplatin/Paclitaxel
|
|---|---|---|
|
Overall Study
Death
|
23
|
20
|
|
Overall Study
Disease Progression
|
13
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
7
|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Administrative Reason By Sponsor
|
0
|
2
|
|
Overall Study
Study Drug Toxicity
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Maximum Clinical Benefit
|
1
|
0
|
|
Overall Study
Subject Requested to Discontinue
|
0
|
1
|
|
Overall Study
Other
|
3
|
3
|
Baseline Characteristics
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin
Baseline characteristics by cohort
| Measure |
Ipi + PAC/CAR
n=98 Participants
Ipilumumab + paclitaxel/Carboplatin
|
Placebo + PAC/CAR
n=106 Participants
Placebo + Carboplatin/Paclitaxel
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 Years
STANDARD_DEVIATION 6.89 • n=99 Participants
|
59.8 Years
STANDARD_DEVIATION 8.22 • n=107 Participants
|
60.3 Years
STANDARD_DEVIATION 7.61 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
81 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
161 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Chinese
|
17 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Approximately 43 months post study startPopulation: All participants who were randomized and received at least 1 dose of blinded study therapy.The sponsor decided to discontinue enrollment and randomization in the study CA184-153 effective 25-Sep-2015. As a result, no data was collected for this primary endpoint
OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
Outcome measures
| Measure |
Ipi + PAC/CAR
n=98 Participants
Ipilumumab + paclitaxel/Carboplatin
|
Placebo + PAC/CAR
n=106 Participants
Placebo + Carboplatin/Paclitaxel
|
|---|---|---|
|
Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy
|
NA months
The sponsor decided to discontinue enrollment and randomization in the study CA184-153 effective 25-Sep-2015. As a result, the primary endpoint was not analyzed for study CA184-153
|
NA months
The sponsor decided to discontinue enrollment and randomization in the study CA184-153 effective 25-Sep-2015. As a result, the primary endpoint was not analyzed for study CA184-153
|
SECONDARY outcome
Timeframe: Approximately 43 months post study startPopulation: All participants who were randomized to a treatment arm. The sponsor decided to discontinue enrollment and randomization in the study CA184-153 effective 25-Sep-2015. As a result, no data was collected for this secondary endpoint
OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
Outcome measures
| Measure |
Ipi + PAC/CAR
n=148 Participants
Ipilumumab + paclitaxel/Carboplatin
|
Placebo + PAC/CAR
n=147 Participants
Placebo + Carboplatin/Paclitaxel
|
|---|---|---|
|
Overall Survival of All Randomized Participants
|
NA months
The sponsor decided to discontinue enrollment and randomization in the study CA184153 effective 25-Sep-2015. As a result, the primary endpoint was not analyzed for study CA184-153
|
NA months
The sponsor decided to discontinue enrollment and randomization in the study CA184153 effective 25-Sep-2015. As a result, the primary endpoint was not analyzed for study CA184-153
|
SECONDARY outcome
Timeframe: Approximately 43 months post study startPopulation: All participants who were randomized and received at least 1 dose of blinded study therapy.The sponsor decided to discontinue enrollment and randomization in the study CA184-153 effective 25-Sep-2015. As a result, no data was collected for this secondary endpoint
PFS is defined as the time between the date of randomization and the date of progression per mWHO criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria was considered to have progressed on the date of death. For those participants who remained alive and had not progressed, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
Outcome measures
| Measure |
Ipi + PAC/CAR
n=98 Participants
Ipilumumab + paclitaxel/Carboplatin
|
Placebo + PAC/CAR
n=106 Participants
Placebo + Carboplatin/Paclitaxel
|
|---|---|---|
|
Progression-free Survival (PFS) Among All Randomized Particiapants Who Received at Least One Dose of Blinded Study Therapy Using Modified World Health Organization (mWHO) Criteria
|
NA months
The sponsor decided to discontinue enrollment and randomization in the study CA184-153 effective 25-Sep-2015. As a result, the secondary endpoint was not analyzed for study CA184-53
|
NA months
The sponsor decided to discontinue enrollment and randomization in the study CA184-153 effective 25-Sep-2015. As a result, the secondary endpoint was not analyzed for study CA184-153
|
Adverse Events
Ipi + PAC/CAR
Serious events: 40 serious events
Other events: 91 other events
Deaths: 15 deaths
Placebo + PAC/CAR
Serious events: 33 serious events
Other events: 87 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Ipi + PAC/CAR
n=98 participants at risk
Ipilumumab + paclitaxel/Carboplatin
|
Placebo + PAC/CAR
n=106 participants at risk
Placebo + Carboplatin/Paclitaxel
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
3/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
3.8%
4/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
2.8%
3/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
2.8%
3/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
1.9%
2/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
2/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
1.9%
2/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Cardiac disorders
Cardiac failure
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Cardiac disorders
Pericardial effusion
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Cardiac disorders
Supraventricular extrasystoles
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Endocrine disorders
Adrenal insufficiency
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Endocrine disorders
Hypophysitis
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Endocrine disorders
Hypopituitarism
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Endocrine disorders
Hypothalamo-pituitary disorder
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Endocrine disorders
Secondary hypothyroidism
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Gastrointestinal disorders
Abdominal distension
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Gastrointestinal disorders
Colitis
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
2/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
General disorders
Asthenia
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
1.9%
2/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
General disorders
Death
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
General disorders
General physical health deterioration
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
General disorders
Oedema peripheral
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
General disorders
Pain
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
General disorders
Pyrexia
|
3.1%
3/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
1.9%
2/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
General disorders
Sudden cardiac death
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Infections and infestations
Bacterial toxaemia
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Infections and infestations
Gastroenteritis
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Infections and infestations
Lung infection
|
4.1%
4/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Infections and infestations
Pneumonia
|
6.1%
6/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
1.9%
2/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Investigations
Glomerular filtration rate decreased
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Investigations
Haemoglobin decreased
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Investigations
Influenza a virus test positive
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
7.1%
7/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
3.8%
4/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Nervous system disorders
Cerebellar ischaemia
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Nervous system disorders
Somnolence
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Psychiatric disorders
Confusional state
|
2.0%
2/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Renal and urinary disorders
Acute kidney injury
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.1%
4/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
3.8%
4/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
2/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Vascular disorders
Hypotension
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
Other adverse events
| Measure |
Ipi + PAC/CAR
n=98 participants at risk
Ipilumumab + paclitaxel/Carboplatin
|
Placebo + PAC/CAR
n=106 participants at risk
Placebo + Carboplatin/Paclitaxel
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
34.7%
34/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
33.0%
35/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Blood and lymphatic system disorders
Erythropenia
|
11.2%
11/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
7.5%
8/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Blood and lymphatic system disorders
Leukopenia
|
35.7%
35/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
39.6%
42/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.1%
4/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
6.6%
7/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Blood and lymphatic system disorders
Neutropenia
|
36.7%
36/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
44.3%
47/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
27.6%
27/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
28.3%
30/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Gastrointestinal disorders
Constipation
|
11.2%
11/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
9.4%
10/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
21/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
10.4%
11/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Gastrointestinal disorders
Nausea
|
11.2%
11/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
16.0%
17/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Gastrointestinal disorders
Vomiting
|
10.2%
10/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
8.5%
9/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
General disorders
Asthenia
|
6.1%
6/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
8.5%
9/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
General disorders
Chest pain
|
4.1%
4/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
5.7%
6/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
General disorders
Fatigue
|
17.3%
17/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
14.2%
15/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
General disorders
Pain
|
6.1%
6/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
2.8%
3/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
General disorders
Pyrexia
|
13.3%
13/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
5.7%
6/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
14/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
14.2%
15/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Investigations
Aspartate aminotransferase increased
|
12.2%
12/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
9.4%
10/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Investigations
Blood albumin decreased
|
6.1%
6/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
1.9%
2/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Investigations
Blood alkaline phosphatase increased
|
5.1%
5/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.1%
6/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Investigations
Haemoglobin decreased
|
35.7%
35/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
26.4%
28/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Investigations
Neutrophil count decreased
|
7.1%
7/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
6.6%
7/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Investigations
Platelet count decreased
|
16.3%
16/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
7.5%
8/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Investigations
Red blood cell count decreased
|
11.2%
11/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
1.9%
2/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Investigations
Weight decreased
|
12.2%
12/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
2.8%
3/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Investigations
White blood cell count decreased
|
14.3%
14/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
14.2%
15/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.5%
26/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
16.0%
17/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.1%
5/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
7/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
8.5%
9/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.1%
5/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
2.8%
3/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
3/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
7.5%
8/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.2%
9/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
6.6%
7/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Nervous system disorders
Dizziness
|
5.1%
5/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
4.7%
5/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Nervous system disorders
Hypoaesthesia
|
12.2%
12/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
6.6%
7/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Nervous system disorders
Neuropathy peripheral
|
7.1%
7/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
2.8%
3/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Psychiatric disorders
Insomnia
|
7.1%
7/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
3.8%
4/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.2%
11/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
6.6%
7/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
7/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
2.8%
3/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.0%
1/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
5.7%
6/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
13/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.00%
0/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.3%
17/98 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
0.94%
1/106 • From first dose of blinded study therapy to 90 days after last dose of blinded study therapy (Approximately 43 months assessed up to May 2018)
|
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 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