Trial Outcomes & Findings for NIvolumab COmbination With Standard First-line Chemotherapy and Radiotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Carcinoma (NCT NCT02434081)
NCT ID: NCT02434081
Last Updated: 2022-08-24
Results Overview
It is defined as the number of patients reaching up to 6 months post-radiotherapy without any episode of CTCAE v4.0 grade ≥3 pneumonitis. It will be used as the primary endpoint for all patients followed for at least 6 months beyond radiotherapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
Time from enrolment until 6 months post-radiotherapy
Results posted on
2022-08-24
Participant Flow
Participant milestones
| Measure |
Concurrent CRT-Nivo
4 doses of nivolumab 360mg concurrently with standard chemo-radiotherapy, followed by 480mg for up to 1 year from start of nivolumab treatment.
Nivolumab: Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.Binding of PD-1 to its ligands, 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Nivolumab inhibits the interaction of programmed cell death Protein 1 (PD-1)with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation.
|
|---|---|
|
Overall Study
STARTED
|
79
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
48
|
Reasons for withdrawal
| Measure |
Concurrent CRT-Nivo
4 doses of nivolumab 360mg concurrently with standard chemo-radiotherapy, followed by 480mg for up to 1 year from start of nivolumab treatment.
Nivolumab: Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.Binding of PD-1 to its ligands, 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Nivolumab inhibits the interaction of programmed cell death Protein 1 (PD-1)with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation.
|
|---|---|
|
Overall Study
Death (never started treatment)
|
2
|
|
Overall Study
Death
|
2
|
|
Overall Study
Progression
|
20
|
|
Overall Study
Adverse Event
|
20
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Patient did not receive treatment for more than six weeks
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Concurrent CRT-Nivo
n=79 Participants
4 doses of nivolumab 360mg concurrently with standard chemo-radiotherapy, followed by 480mg for up to 1 year from start of nivolumab treatment.
Nivolumab: Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.Binding of PD-1 to its ligands, 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Nivolumab inhibits the interaction of programmed cell death Protein 1 (PD-1)with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=79 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=79 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=79 Participants
|
|
Age, Continuous
|
62 years
n=79 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=79 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=79 Participants
|
|
Region of Enrollment
Netherlands
|
14 participants
n=79 Participants
|
|
Region of Enrollment
Belgium
|
12 participants
n=79 Participants
|
|
Region of Enrollment
Switzerland
|
11 participants
n=79 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=79 Participants
|
|
Region of Enrollment
Spain
|
29 participants
n=79 Participants
|
PRIMARY outcome
Timeframe: Time from enrolment until 6 months post-radiotherapyIt is defined as the number of patients reaching up to 6 months post-radiotherapy without any episode of CTCAE v4.0 grade ≥3 pneumonitis. It will be used as the primary endpoint for all patients followed for at least 6 months beyond radiotherapy.
Outcome measures
| Measure |
Chemo-radiotherapy With Concurrent Nivolumab
n=77 Participants
4 doses of nivolumab 360mg concurrently with standard chemo-radiotherapy, followed by 480mg for up to 1 year from start of nivolumab treatment.
Nivolumab: Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.Binding of PD-1 to its ligands, 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Nivolumab inhibits the interaction of programmed cell death Protein 1 (PD-1)with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation.
|
|---|---|
|
Grade ≥3 Pneumonitis (CTCAE v4.0) up to 6 Months Post-radiotherapy
|
71 Participants
|
SECONDARY outcome
Timeframe: From the date of enrolment of the first patient up to 3 years, which is also 1 year after the enrolment of the last patient (i.e., from September 2016 to September 2019)Population: ITT cohort
PFS, κey secondary endpoint, is defined as the time from the date of enrolment until first documented progression or death, if progression is not documented. For patients without a PFS event, censoring occurs at the last tumour assessment. Database cutoff: 18 September 2019
Outcome measures
| Measure |
Chemo-radiotherapy With Concurrent Nivolumab
n=79 Participants
4 doses of nivolumab 360mg concurrently with standard chemo-radiotherapy, followed by 480mg for up to 1 year from start of nivolumab treatment.
Nivolumab: Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.Binding of PD-1 to its ligands, 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Nivolumab inhibits the interaction of programmed cell death Protein 1 (PD-1)with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation.
|
|---|---|
|
Progression-free Survival by RECIST v1.1 (PFS)
|
12.7 months
Interval 10.1 to 22.8
|
SECONDARY outcome
Timeframe: From the date of enrolment of the first patient up to 3 years, which is also 1 year after the enrolment of the last patient (i.e., from September 2016 to September 2019)Population: Estimate of 1-year TFP3% based on the safety cohort (N=77 pts)
Rate of TFP3, evaluated at 1-year based on Kaplan-Meier method, where TFP3 is defined as the time from the date of enrolment until first documented pneumonitis of grade ≥3.
Outcome measures
| Measure |
Chemo-radiotherapy With Concurrent Nivolumab
n=77 Participants
4 doses of nivolumab 360mg concurrently with standard chemo-radiotherapy, followed by 480mg for up to 1 year from start of nivolumab treatment.
Nivolumab: Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.Binding of PD-1 to its ligands, 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Nivolumab inhibits the interaction of programmed cell death Protein 1 (PD-1)with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation.
|
|---|---|
|
(Grade ≥3) Pneumonitis-free Rate
|
87.0 percentage of participants
Interval 76.4 to 93.0
|
SECONDARY outcome
Timeframe: From the date of enrolment of the first patient up to 3 years, which is also 1 year after the enrolment of the last patient (i.e., from September 2016 to September 2019)Population: ITT cohort
Objective response rate (ORR) is defined as the percentage of patients with objective response (OR). OR was determined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). OR is defined as the best overall response (Complete Response (disappearance of all target and non-target lesions; no new lesions) or Partial Response (≥decrease in the sum of the largest diameters of target lesions; no new lesions)) across all assessment points from enrollment to termination of trial treatment. Radiological tumour assessment was performed using CT scans.
Outcome measures
| Measure |
Chemo-radiotherapy With Concurrent Nivolumab
n=79 Participants
4 doses of nivolumab 360mg concurrently with standard chemo-radiotherapy, followed by 480mg for up to 1 year from start of nivolumab treatment.
Nivolumab: Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.Binding of PD-1 to its ligands, 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Nivolumab inhibits the interaction of programmed cell death Protein 1 (PD-1)with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation.
|
|---|---|
|
Objective Response Rate (ORR)
|
73.4 percentage of patients with OR
Interval 62.3 to 82.7
|
SECONDARY outcome
Timeframe: From the date of enrolment of the first patient up to 3 years, which is also 1 year after the enrolment of the last patient (i.e., from September 2016 to September 2019)Population: based on ITT cohort
Time to treatment failure (TTF) is defined as time from enrolment to discontinuation of trial treatment for any reason. Disease progression, treatment toxicity, death, withdrawal and lost to follow-up which occurred after treatment completion are viewed as events.
Outcome measures
| Measure |
Chemo-radiotherapy With Concurrent Nivolumab
n=79 Participants
4 doses of nivolumab 360mg concurrently with standard chemo-radiotherapy, followed by 480mg for up to 1 year from start of nivolumab treatment.
Nivolumab: Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.Binding of PD-1 to its ligands, 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Nivolumab inhibits the interaction of programmed cell death Protein 1 (PD-1)with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation.
|
|---|---|
|
Time to Treatment Failure (TTF).
|
9.2 months
Interval 6.4 to 12.4
|
SECONDARY outcome
Timeframe: From the date of enrolment of the first patient up to 4 years (i.e., from September 2016 to September 2020).Population: ITT cohort
OS is defined as the time from the date of enrolment until death from any cause. The patients without OS event (death) were censored at their last follow-up date
Outcome measures
| Measure |
Chemo-radiotherapy With Concurrent Nivolumab
n=79 Participants
4 doses of nivolumab 360mg concurrently with standard chemo-radiotherapy, followed by 480mg for up to 1 year from start of nivolumab treatment.
Nivolumab: Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.Binding of PD-1 to its ligands, 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Nivolumab inhibits the interaction of programmed cell death Protein 1 (PD-1)with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation.
|
|---|---|
|
Overall Survival (OS)
|
38.8 months
Interval 26.8 to
The upper 95% confidence limit is not estimable.
|
Adverse Events
Concurrent CRT-Nivo
Serious events: 37 serious events
Other events: 76 other events
Deaths: 37 deaths
Serious adverse events
| Measure |
Concurrent CRT-Nivo
n=77 participants at risk
4 doses of nivolumab 360mg concurrently with standard chemo-radiotherapy, followed by 480mg for up to 1 year from start of nivolumab treatment.
Nivolumab: Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.Binding of PD-1 to its ligands, 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Nivolumab inhibits the interaction of programmed cell death Protein 1 (PD-1)with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
2.6%
2/77 • Number of events 2 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
General disorders
Fever
|
3.9%
3/77 • Number of events 3 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
3/77 • Number of events 3 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Gastrointestinal disorders
Colitis
|
2.6%
2/77 • Number of events 2 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
General disorders
Pain
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Gastrointestinal disorders
Esophageal fistula
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Infections and infestations
Sepsis
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Infections and infestations
Bronchial infection
|
2.6%
2/77 • Number of events 2 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.9%
13/77 • Number of events 13 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
3.9%
3/77 • Number of events 3 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Infections and infestations
Lung infection
|
2.6%
2/77 • Number of events 2 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Nervous system disorders
Stroke
|
3.9%
3/77 • Number of events 3 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.2%
4/77 • Number of events 4 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
General disorders
Malaise
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Infections and infestations
Catheter related infection
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial stricture
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Cardiac disorders
Heart failure
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Immune system disorders
Autoimmune disorder
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Infections and infestations
Upper respiratory infection
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Nervous system disorders
Ataxia
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Cardiac disorders
Myocarditis
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Gastrointestinal disorders
Esophageal varices hemorrhage
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Immune system disorders
Allergic reaction
|
1.3%
1/77 • Number of events 1 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
Other adverse events
| Measure |
Concurrent CRT-Nivo
n=77 participants at risk
4 doses of nivolumab 360mg concurrently with standard chemo-radiotherapy, followed by 480mg for up to 1 year from start of nivolumab treatment.
Nivolumab: Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.Binding of PD-1 to its ligands, 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Nivolumab inhibits the interaction of programmed cell death Protein 1 (PD-1)with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
46.8%
36/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
32.5%
25/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
5.2%
4/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Endocrine disorders
Hypothyroidism
|
7.8%
6/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
6.5%
5/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
33.8%
26/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
27.3%
21/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Gastrointestinal disorders
Nausea
|
22.1%
17/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
15.6%
12/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Gastrointestinal disorders
Vomiting
|
13.0%
10/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Gastrointestinal disorders
Constipation
|
10.4%
8/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Gastrointestinal disorders
Esophageal pain
|
9.1%
7/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
6.5%
5/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
General disorders
Fatigue
|
49.4%
38/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
General disorders
Fever
|
15.6%
12/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
General disorders
Pain
|
15.6%
12/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
General disorders
Flu like symptoms
|
7.8%
6/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
General disorders
Non-cardiac chest pain
|
6.5%
5/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Infections and infestations
Bronchial infection
|
7.8%
6/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Infections and infestations
Upper respiratory infection
|
7.8%
6/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Infections and infestations
Lung infection
|
5.2%
4/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.2%
4/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
6.5%
5/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Investigations
Lipase increased
|
11.7%
9/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Investigations
Lymphocyte count decreased
|
11.7%
9/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Investigations
Platelet count decreased
|
11.7%
9/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Investigations
White blood cell decreased
|
11.7%
9/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Investigations
Creatinine increased
|
10.4%
8/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Investigations
Serum amylase increased
|
10.4%
8/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Investigations
Alanine aminotransferase increased
|
7.8%
6/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
6.5%
5/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Investigations
Weight gain
|
5.2%
4/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
18.2%
14/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.8%
6/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.7%
9/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Nervous system disorders
Dizziness
|
14.3%
11/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Nervous system disorders
Headache
|
7.8%
6/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.5%
5/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Nervous system disorders
Tremor
|
5.2%
4/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Psychiatric disorders
Insomnia
|
16.9%
13/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Psychiatric disorders
Anxiety
|
5.2%
4/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
27.3%
21/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
40.3%
31/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
32.5%
25/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.6%
12/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.0%
10/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.8%
6/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.5%
5/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.2%
4/77 • Adverse events (AEs) were recorded from the date of first trial treatment until 100 days after the final dose of nivolumab, regardless of whether they were considered related to the trial treatment. After the last dose, only AEs considered possibly related to nivolumab had to be reported. Any known untoward event that occurred subsequent to the AE reporting period, possibly related to the protocol treatment, was considered an AE.
In the 'All Cause Mortality' section, number of at risk patients includes all enrolled patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment.
|
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