Trial Outcomes & Findings for Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease (NCT NCT02046733)
NCT ID: NCT02046733
Last Updated: 2024-11-08
Results Overview
Defined as the time from the date of randomization until documented progression or death, if progression is not documented. Censoring for PFS occurs at the last tumor assessment. Assessment of Progressive Disease (PD) based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Target lesions: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on the study (this includes the baseline sum if that is the smallest on the study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Non-target lesions: Unequivocal progression of existing non-target lesions. To achieve 'unequivocal progression', there must be an overall level of substantial worsening in non-target disease such that, even in presence of SD or PR in target disease, the overall tumor burden has increased sufficiently. The appearance of one or more new lesions is also considered as progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
222 participants
Primary outcome timeframe
From the date of randomization until documented progression (PD) according to RECIST v1.1 or death from any cause (whichever occurred first), up to 4.5 years.
Results posted on
2024-11-08
Participant Flow
From December 2015 to April 2019, a total of 222 patients were enrolled to the chemotherapy phase under protocol AM1 coming from 52 centers of 8 countries (France, Spain, Germany, Netherlands, Switzerland, United Kingdom, Belgium, and Australia). Overall, 153 patients were randomized under AM1 and constitute the ITT cohort of the efficacy analysis (145 of those were enrolled under AM1 and 8 were initially enrolled under the original protocol).
Participant milestones
| Measure |
Observation
no further treatment; tumour assessment, follow-up documentation and collection of biological material will be done according to the same schedule as the experimental arm (nivolumab+ipilimumab).
|
Nivolumab + Ipilimumab
* Induction phase to start within 6-8 weeks (42-56 days) after the start of chemotherapy cycle 4, and not more than 2 weeks (14 days) after the date of randomisation): Nivolumab at a dose of 1 mg/kg i.v. over a period of 30 minutes followed (on the same day) by Ipilimumab at a dose of 3 mg/kg i.v. over a period of 90 minutes once every 3 weeks (+/- 3 days, without dosing delay), for 4 cycles.
* Maintenance phase (to start 3 weeks (21 days) after the last IMP dose of induction phase): Nivolumab 240 mg i.v. over a period of 30 minutes, once every 2 weeks (+/- 2 days, without dosing delay), for a maximum of 12 months from the start of maintenance phase.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
78
|
|
Overall Study
COMPLETED
|
69
|
78
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
Observation
no further treatment; tumour assessment, follow-up documentation and collection of biological material will be done according to the same schedule as the experimental arm (nivolumab+ipilimumab).
|
Nivolumab + Ipilimumab
* Induction phase to start within 6-8 weeks (42-56 days) after the start of chemotherapy cycle 4, and not more than 2 weeks (14 days) after the date of randomisation): Nivolumab at a dose of 1 mg/kg i.v. over a period of 30 minutes followed (on the same day) by Ipilimumab at a dose of 3 mg/kg i.v. over a period of 90 minutes once every 3 weeks (+/- 3 days, without dosing delay), for 4 cycles.
* Maintenance phase (to start 3 weeks (21 days) after the last IMP dose of induction phase): Nivolumab 240 mg i.v. over a period of 30 minutes, once every 2 weeks (+/- 2 days, without dosing delay), for a maximum of 12 months from the start of maintenance phase.
|
|---|---|---|
|
Overall Study
never initiated 'treatment visits'
|
6
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Observation
n=75 Participants
no further treatment; tumour assessment, follow-up documentation and collection of biological material will be done according to the same schedule as the experimental arm (nivolumab+ipilimumab).
|
Nivolumab + Ipilimumab
n=78 Participants
* Induction phase to start within 6-8 weeks (42-56 days) after the start of chemotherapy cycle 4, and not more than 2 weeks (14 days) after the date of randomisation): Nivolumab at a dose of 1 mg/kg i.v. over a period of 30 minutes followed (on the same day) by Ipilimumab at a dose of 3 mg/kg i.v. over a period of 90 minutes once every 3 weeks (+/- 3 days, without dosing delay), for 4 cycles.
* Maintenance phase (to start 3 weeks (21 days) after the last IMP dose of induction phase): Nivolumab 240 mg i.v. over a period of 30 minutes, once every 2 weeks (+/- 2 days, without dosing delay), for a maximum of 12 months from the start of maintenance phase.
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.9 years
n=75 Participants
|
61.1 years
n=78 Participants
|
61.5 years
n=153 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=75 Participants
|
28 Participants
n=78 Participants
|
61 Participants
n=153 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=75 Participants
|
50 Participants
n=78 Participants
|
92 Participants
n=153 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Netherlands
|
7 participants
n=75 Participants
|
7 participants
n=78 Participants
|
14 participants
n=153 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=75 Participants
|
3 participants
n=78 Participants
|
7 participants
n=153 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=75 Participants
|
3 participants
n=78 Participants
|
4 participants
n=153 Participants
|
|
Region of Enrollment
France
|
24 participants
n=75 Participants
|
31 participants
n=78 Participants
|
55 participants
n=153 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=75 Participants
|
3 participants
n=78 Participants
|
5 participants
n=153 Participants
|
|
Region of Enrollment
Switzerland
|
5 participants
n=75 Participants
|
4 participants
n=78 Participants
|
9 participants
n=153 Participants
|
|
Region of Enrollment
Germany
|
9 participants
n=75 Participants
|
7 participants
n=78 Participants
|
16 participants
n=153 Participants
|
|
Region of Enrollment
Spain
|
23 participants
n=75 Participants
|
20 participants
n=78 Participants
|
43 participants
n=153 Participants
|
|
Smoking history
Current
|
25 Participants
n=75 Participants
|
27 Participants
n=78 Participants
|
52 Participants
n=153 Participants
|
|
Smoking history
Former (≥ 100 cigarettes in the past during the whole life)
|
49 Participants
n=75 Participants
|
51 Participants
n=78 Participants
|
100 Participants
n=153 Participants
|
|
Smoking history
Never (0-99 cigarettes during the whole life)
|
1 Participants
n=75 Participants
|
0 Participants
n=78 Participants
|
1 Participants
n=153 Participants
|
|
ECOG performance status (at randomization)
0
|
23 Participants
n=75 Participants
|
25 Participants
n=78 Participants
|
48 Participants
n=153 Participants
|
|
ECOG performance status (at randomization)
1
|
51 Participants
n=75 Participants
|
50 Participants
n=78 Participants
|
101 Participants
n=153 Participants
|
|
ECOG performance status (at randomization)
2
|
1 Participants
n=75 Participants
|
3 Participants
n=78 Participants
|
4 Participants
n=153 Participants
|
|
Stage
IA
|
2 Participants
n=75 Participants
|
0 Participants
n=78 Participants
|
2 Participants
n=153 Participants
|
|
Stage
IB
|
1 Participants
n=75 Participants
|
2 Participants
n=78 Participants
|
3 Participants
n=153 Participants
|
|
Stage
IIA
|
5 Participants
n=75 Participants
|
3 Participants
n=78 Participants
|
8 Participants
n=153 Participants
|
|
Stage
IIB
|
2 Participants
n=75 Participants
|
6 Participants
n=78 Participants
|
8 Participants
n=153 Participants
|
|
Stage
IIIA
|
27 Participants
n=75 Participants
|
26 Participants
n=78 Participants
|
53 Participants
n=153 Participants
|
|
Stage
IIIB
|
36 Participants
n=75 Participants
|
40 Participants
n=78 Participants
|
76 Participants
n=153 Participants
|
|
Stage
Missing
|
2 Participants
n=75 Participants
|
1 Participants
n=78 Participants
|
3 Participants
n=153 Participants
|
|
Response to chemo-radiotherapy (before randomization)
Complete response
|
11 Participants
n=75 Participants
|
9 Participants
n=78 Participants
|
20 Participants
n=153 Participants
|
|
Response to chemo-radiotherapy (before randomization)
Partial response
|
60 Participants
n=75 Participants
|
65 Participants
n=78 Participants
|
125 Participants
n=153 Participants
|
|
Response to chemo-radiotherapy (before randomization)
Stable disease
|
3 Participants
n=75 Participants
|
4 Participants
n=78 Participants
|
7 Participants
n=153 Participants
|
|
Response to chemo-radiotherapy (before randomization)
Not evaluable
|
1 Participants
n=75 Participants
|
0 Participants
n=78 Participants
|
1 Participants
n=153 Participants
|
|
Number of radiotherapy fractions pre day
1
|
49 Participants
n=75 Participants
|
48 Participants
n=78 Participants
|
97 Participants
n=153 Participants
|
|
Number of radiotherapy fractions pre day
2
|
26 Participants
n=75 Participants
|
30 Participants
n=78 Participants
|
56 Participants
n=153 Participants
|
|
PET-CT
Done
|
26 Participants
n=75 Participants
|
25 Participants
n=78 Participants
|
51 Participants
n=153 Participants
|
|
PET-CT
Not done
|
49 Participants
n=75 Participants
|
53 Participants
n=78 Participants
|
102 Participants
n=153 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization until documented progression (PD) according to RECIST v1.1 or death from any cause (whichever occurred first), up to 4.5 years.Population: Intention-to-treat (ITT) population
Defined as the time from the date of randomization until documented progression or death, if progression is not documented. Censoring for PFS occurs at the last tumor assessment. Assessment of Progressive Disease (PD) based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Target lesions: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on the study (this includes the baseline sum if that is the smallest on the study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Non-target lesions: Unequivocal progression of existing non-target lesions. To achieve 'unequivocal progression', there must be an overall level of substantial worsening in non-target disease such that, even in presence of SD or PR in target disease, the overall tumor burden has increased sufficiently. The appearance of one or more new lesions is also considered as progression.
Outcome measures
| Measure |
Observation
n=75 Participants
no further treatment; tumour assessment, follow-up documentation and collection of biological material will be done according to the same schedule as the experimental arm (nivolumab+ipilimumab).
|
Nivolumab + Ipilimumab
n=78 Participants
* Induction phase to start within 6-8 weeks (42-56 days) after the start of chemotherapy cycle 4, and not more than 2 weeks (14 days) after the date of randomisation): Nivolumab at a dose of 1 mg/kg i.v. over a period of 30 minutes followed (on the same day) by Ipilimumab at a dose of 3 mg/kg i.v. over a period of 90 minutes once every 3 weeks (+/- 3 days, without dosing delay), for 4 cycles.
* Maintenance phase (to start 3 weeks (21 days) after the last IMP dose of induction phase): Nivolumab 240 mg i.v. over a period of 30 minutes, once every 2 weeks (+/- 2 days, without dosing delay), for a maximum of 12 months from the start of maintenance phase.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
14.5 months
Interval 8.2 to
The upper 95% confidence limit for the median PFS time is not estimable because the upper limit of the survival curve hasn't reached 50%.
|
10.7 months
Interval 7.0 to
The upper 95% confidence limit for the median PFS time is not estimable because the upper limit of the survival curve hasn't reached 50%.
|
SECONDARY outcome
Timeframe: From the date of randomization until death from any cause, up to 5.5 years.Population: Intention-to-treat (ITT) population
Defined as the time from the date of randomisation until death from any cause. Censoring for OS occurs at the last follow-up date.
Outcome measures
| Measure |
Observation
n=75 Participants
no further treatment; tumour assessment, follow-up documentation and collection of biological material will be done according to the same schedule as the experimental arm (nivolumab+ipilimumab).
|
Nivolumab + Ipilimumab
n=78 Participants
* Induction phase to start within 6-8 weeks (42-56 days) after the start of chemotherapy cycle 4, and not more than 2 weeks (14 days) after the date of randomisation): Nivolumab at a dose of 1 mg/kg i.v. over a period of 30 minutes followed (on the same day) by Ipilimumab at a dose of 3 mg/kg i.v. over a period of 90 minutes once every 3 weeks (+/- 3 days, without dosing delay), for 4 cycles.
* Maintenance phase (to start 3 weeks (21 days) after the last IMP dose of induction phase): Nivolumab 240 mg i.v. over a period of 30 minutes, once every 2 weeks (+/- 2 days, without dosing delay), for a maximum of 12 months from the start of maintenance phase.
|
|---|---|---|
|
Overall Survival (OS)
|
32.1 months
Interval 26.1 to
The upper 95% confidence limit for the median OS time is not estimable because the upper limit of the survival curve hasn't reached 50%.
|
NA months
Interval 24.1 to
Median OS is not reached (i.e survival curve doesn't cross 50% because survival is greater than 50% at the last time point) and the upper 95% confidence limit for the median OS time is not estimable because the upper limit of the survival curve hasn't reached 50%.
|
SECONDARY outcome
Timeframe: From randomisation to termination of trial treatment, for a maximum of 12 months from start of maintenance phase.Population: Include only patients who have not attained a CR during the chemoradiotherapy phase.
Objective response is defined as the best overall response (complete or partial response) according to RECIST 1.1 criteria across all assessment time-points during the period from randomisation to termination of trial treatment. Of note, the determination of OR is restricted to patients who have not attained a CR during the chemo-radiotherapy phase. Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters, Progression (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on the trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm., Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on the trial.
Outcome measures
| Measure |
Observation
n=64 Participants
no further treatment; tumour assessment, follow-up documentation and collection of biological material will be done according to the same schedule as the experimental arm (nivolumab+ipilimumab).
|
Nivolumab + Ipilimumab
n=69 Participants
* Induction phase to start within 6-8 weeks (42-56 days) after the start of chemotherapy cycle 4, and not more than 2 weeks (14 days) after the date of randomisation): Nivolumab at a dose of 1 mg/kg i.v. over a period of 30 minutes followed (on the same day) by Ipilimumab at a dose of 3 mg/kg i.v. over a period of 90 minutes once every 3 weeks (+/- 3 days, without dosing delay), for 4 cycles.
* Maintenance phase (to start 3 weeks (21 days) after the last IMP dose of induction phase): Nivolumab 240 mg i.v. over a period of 30 minutes, once every 2 weeks (+/- 2 days, without dosing delay), for a maximum of 12 months from the start of maintenance phase.
|
|---|---|---|
|
Objective Response (OR)
Complete response
|
8 Participants
|
6 Participants
|
|
Objective Response (OR)
Partial response
|
22 Participants
|
20 Participants
|
|
Objective Response (OR)
Stable disease
|
22 Participants
|
28 Participants
|
|
Objective Response (OR)
Progressive disease
|
10 Participants
|
9 Participants
|
|
Objective Response (OR)
Non-evaluable
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From the date of randomization to treatment failure for any reason, up to 4.5 years.Population: Intention-to-treat (ITT) population
Defined as the time from the date of randomisation to discontinuation of treatment for any reason (including progression of disease, treatment toxicity, refusal, lost to follow-up, and death). Censoring for TTF occurs at the last follow-up date.
Outcome measures
| Measure |
Observation
n=75 Participants
no further treatment; tumour assessment, follow-up documentation and collection of biological material will be done according to the same schedule as the experimental arm (nivolumab+ipilimumab).
|
Nivolumab + Ipilimumab
n=78 Participants
* Induction phase to start within 6-8 weeks (42-56 days) after the start of chemotherapy cycle 4, and not more than 2 weeks (14 days) after the date of randomisation): Nivolumab at a dose of 1 mg/kg i.v. over a period of 30 minutes followed (on the same day) by Ipilimumab at a dose of 3 mg/kg i.v. over a period of 90 minutes once every 3 weeks (+/- 3 days, without dosing delay), for 4 cycles.
* Maintenance phase (to start 3 weeks (21 days) after the last IMP dose of induction phase): Nivolumab 240 mg i.v. over a period of 30 minutes, once every 2 weeks (+/- 2 days, without dosing delay), for a maximum of 12 months from the start of maintenance phase.
|
|---|---|---|
|
Time-to-treatment Failure (TTF)
|
14.5 months
Interval 8.2 to 24.0
|
1.7 months
Interval 1.2 to 2.5
|
SECONDARY outcome
Timeframe: Adverse events were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years.Population: Safety population, i.e., all patients who have received at least one dose of study treatment in the experimental arm (nivolumab\_ipilimumab) plus all patients randomised to observation arm.
Adverse events graded according to NCI CTCAE V4.0.
Outcome measures
| Measure |
Observation
n=75 Participants
no further treatment; tumour assessment, follow-up documentation and collection of biological material will be done according to the same schedule as the experimental arm (nivolumab+ipilimumab).
|
Nivolumab + Ipilimumab
n=78 Participants
* Induction phase to start within 6-8 weeks (42-56 days) after the start of chemotherapy cycle 4, and not more than 2 weeks (14 days) after the date of randomisation): Nivolumab at a dose of 1 mg/kg i.v. over a period of 30 minutes followed (on the same day) by Ipilimumab at a dose of 3 mg/kg i.v. over a period of 90 minutes once every 3 weeks (+/- 3 days, without dosing delay), for 4 cycles.
* Maintenance phase (to start 3 weeks (21 days) after the last IMP dose of induction phase): Nivolumab 240 mg i.v. over a period of 30 minutes, once every 2 weeks (+/- 2 days, without dosing delay), for a maximum of 12 months from the start of maintenance phase.
|
|---|---|---|
|
Adverse Events
Experienced AE/SAE
|
65 Participants
|
77 Participants
|
|
Adverse Events
Not experienced AE/SAE
|
10 Participants
|
1 Participants
|
Adverse Events
Observation
Serious events: 12 serious events
Other events: 62 other events
Deaths: 37 deaths
Nivolumab + Ipilimumab
Serious events: 48 serious events
Other events: 72 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
Observation
n=75 participants at risk
no further treatment; tumour assessment, follow-up documentation and collection of biological material will be done according to the same schedule as the experimental arm (nivolumab+ipilimumab).
|
Nivolumab + Ipilimumab
n=78 participants at risk
* Induction phase to start within 6-8 weeks (42-56 days) after the start of chemotherapy cycle 4, and not more than 2 weeks (14 days) after the date of randomisation): Nivolumab at a dose of 1 mg/kg i.v. over a period of 30 minutes followed (on the same day) by Ipilimumab at a dose of 3 mg/kg i.v. over a period of 90 minutes once every 3 weeks (+/- 3 days, without dosing delay), for 4 cycles.
* Maintenance phase (to start 3 weeks (21 days) after the last IMP dose of induction phase): Nivolumab 240 mg i.v. over a period of 30 minutes, once every 2 weeks (+/- 2 days, without dosing delay), for a maximum of 12 months from the start of maintenance phase.
|
|---|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Endocrine disorders
Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
0.00%
0/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Endocrine disorders
Hyperthyroidism
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
3.8%
3/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Eye disorders
Retinopathy
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
2.6%
2/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
2.6%
2/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
10.3%
8/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
General disorders
Death NOS
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
General disorders
Fever
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
3.8%
3/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
General disorders
Flu like symptoms
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
General disorders
Gait disturbance
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
0.00%
0/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
General disorders
Malaise
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
2.6%
2/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
2.6%
2/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Infections and infestations
Viral meningitis
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
0.00%
0/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Infections and infestations
Lung infection
|
2.7%
2/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
7.7%
6/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Investigations
White blood cell decreased
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
0.00%
0/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
2.6%
2/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
0.00%
0/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
2.6%
2/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
3.8%
3/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Psychiatric disorders
Confusion
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
0.00%
0/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
0.00%
0/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
11.5%
9/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Vascular disorders
Hypotension
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Vascular disorders
Thromboembolic event
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
1.3%
1/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
Other adverse events
| Measure |
Observation
n=75 participants at risk
no further treatment; tumour assessment, follow-up documentation and collection of biological material will be done according to the same schedule as the experimental arm (nivolumab+ipilimumab).
|
Nivolumab + Ipilimumab
n=78 participants at risk
* Induction phase to start within 6-8 weeks (42-56 days) after the start of chemotherapy cycle 4, and not more than 2 weeks (14 days) after the date of randomisation): Nivolumab at a dose of 1 mg/kg i.v. over a period of 30 minutes followed (on the same day) by Ipilimumab at a dose of 3 mg/kg i.v. over a period of 90 minutes once every 3 weeks (+/- 3 days, without dosing delay), for 4 cycles.
* Maintenance phase (to start 3 weeks (21 days) after the last IMP dose of induction phase): Nivolumab 240 mg i.v. over a period of 30 minutes, once every 2 weeks (+/- 2 days, without dosing delay), for a maximum of 12 months from the start of maintenance phase.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
17.3%
13/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
9.0%
7/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
24.4%
19/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
15.4%
12/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
9.0%
7/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Gastrointestinal disorders
Constipation
|
4.0%
3/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
17.9%
14/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
8.0%
6/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
17.9%
14/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
7.7%
6/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Gastrointestinal disorders
Dysphagia
|
2.7%
2/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
5.1%
4/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
6.4%
5/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Gastrointestinal disorders
Nausea
|
8.0%
6/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
23.1%
18/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
5/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
25.6%
20/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
General disorders
Chills
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
6.4%
5/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
General disorders
Fatigue
|
28.0%
21/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
48.7%
38/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
General disorders
Fever
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
10.3%
8/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
General disorders
Pain
|
12.0%
9/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
11.5%
9/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Infections and infestations
Lung infection
|
2.7%
2/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
5.1%
4/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Infections and infestations
Upper respiratory infection
|
2.7%
2/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
5.1%
4/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Infections and infestations
Urinary tract infection
|
4.0%
3/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
9.0%
7/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Investigations
Alanine aminotransferase increased
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
7.7%
6/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
6.4%
5/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Investigations
Platelet count decreased
|
6.7%
5/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
5.1%
4/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Investigations
Weight loss
|
2.7%
2/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
9.0%
7/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.0%
12/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
29.5%
23/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
3/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
5.1%
4/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.3%
7/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
5.1%
4/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
6.4%
5/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Nervous system disorders
Dizziness
|
10.7%
8/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
11.5%
9/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Nervous system disorders
Headache
|
2.7%
2/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
14.1%
11/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.7%
2/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
9.0%
7/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Psychiatric disorders
Depression
|
2.7%
2/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
6.4%
5/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Psychiatric disorders
Insomnia
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
6.4%
5/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
5/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
25.6%
20/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
5/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
15.4%
12/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.0%
3/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
16.7%
13/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
6.4%
5/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
5.1%
4/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
24.4%
19/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.3%
1/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
5.1%
4/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/75 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
12.8%
10/78 • Reported adverse events (AEs) were assessed from randomization to 100 days after the last dose of study treatment, up to 4.5 years. Only all-cause mortality was from randomization up to 5.5 years.
|
Additional Information
Heidi Roschitzki-Voser
European Thoracic Oncology Platform (ETOP)
Phone: +41 31 511 94 18
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place