Trial Outcomes & Findings for Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens (NCT NCT01721759)
NCT ID: NCT01721759
Last Updated: 2022-06-28
Results Overview
ORR is defined as the percentage of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment. The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
117 participants
Primary outcome timeframe
Day 1 of treatment up to approximately 14 months
Results posted on
2022-06-28
Participant Flow
117 participants treated.
Participant milestones
| Measure |
Nivolumab, 3 mg/kg
Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
|
|---|---|
|
Treatment Period
STARTED
|
117
|
|
Treatment Period
COMPLETED
|
0
|
|
Treatment Period
NOT COMPLETED
|
117
|
|
End of Study Period
STARTED
|
117
|
|
End of Study Period
COMPLETED
|
0
|
|
End of Study Period
NOT COMPLETED
|
117
|
Reasons for withdrawal
| Measure |
Nivolumab, 3 mg/kg
Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
|
|---|---|
|
Treatment Period
Disease Progression
|
85
|
|
Treatment Period
Study drug toxicity
|
14
|
|
Treatment Period
Death
|
1
|
|
Treatment Period
Adverse event unrelated to study drug
|
11
|
|
Treatment Period
Participant request to withdraw
|
3
|
|
Treatment Period
Other Reasons
|
3
|
|
End of Study Period
Participant Withdrew Consent
|
5
|
|
End of Study Period
Death
|
101
|
|
End of Study Period
Lost to Follow-up
|
1
|
|
End of Study Period
Other Reasons
|
10
|
Baseline Characteristics
Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens
Baseline characteristics by cohort
| Measure |
Nivolumab, 3 mg/kg
n=117 Participants
Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
|
|---|---|
|
Age, Continuous
|
64.1 Years
STANDARD_DEVIATION 9.11 • n=5 Participants
|
|
Age, Customized
Younger than 65 years
|
58 Participants
n=5 Participants
|
|
Age, Customized
At least 65 years and younger than 75 years
|
43 Participants
n=5 Participants
|
|
Age, Customized
75 years and older
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
99 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
|
Disease stage
Stage IIIB
|
20 Participants
n=5 Participants
|
|
Disease stage
Stage IV
|
97 Participants
n=5 Participants
|
|
Cell type
Squamous cell carcinoma
|
117 Participants
n=5 Participants
|
|
Cell type
Other
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
26 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
91 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
3
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
4
|
0 Participants
n=5 Participants
|
|
Central nervous system metastasis
Yes
|
2 Participants
n=5 Participants
|
|
Central nervous system metastasis
No
|
115 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 of treatment up to approximately 14 monthsPopulation: All Treated Participants
ORR is defined as the percentage of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment. The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method.
Outcome measures
| Measure |
Nivolumab, 3 mg/kg
n=117 Participants
Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
|
|---|---|
|
Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC)
|
14.5 Percentage of Participants
Interval 8.7 to 22.2
|
PRIMARY outcome
Timeframe: From the first treatment to the date of the first documented tumor progression or death. Approximately up to 14 monthsPopulation: All confirmed responders per IRC
DOR is defined as the time from first confirmed response (CR or PR) per IRC assessment to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Median values of DOR, along with two-sided 95% CI in each treatment group will be computed based on a log-log transformation method.
Outcome measures
| Measure |
Nivolumab, 3 mg/kg
n=17 Participants
Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
|
|---|---|
|
Duration of Response (DOR) as Assessed by Independent Radiology Review Committee (IRC)
|
12 Months
Interval 6.7 to 19.3
|
SECONDARY outcome
Timeframe: Day 1 of treatment to approximately 101 monthsPopulation: All Treated Participants
ORR is defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on investigator assessment. The investigator-assessed ORR is summarized by a binomial response rate and its corresponding two-sided 95% exact CIs using Clopper-Pearson method.
Outcome measures
| Measure |
Nivolumab, 3 mg/kg
n=117 Participants
Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
|
|---|---|
|
Objective Response Rate (ORR) as Assessed by Investigator
|
15.4 Percentage of Participants
Interval 9.4 to 23.2
|
SECONDARY outcome
Timeframe: From the first treatment to the date of the first documented tumor progression or death. Approximately up to 101 monthsPopulation: All treated participants who responded
DOR is defined as the time from first confirmed response (CR or PR) per investigator assessment to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Median values of DOR, along with two-sided 95% CI in each treatment group will be computed based on a log-log transformation method.
Outcome measures
| Measure |
Nivolumab, 3 mg/kg
n=18 Participants
Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
|
|---|---|
|
Duration of Response (DOR) as Assessed by Investigator
|
16.00 Months
Interval 12.45 to 29.54
|
POST_HOC outcome
Timeframe: From the first treatment to the date of the first documented tumor progression or death. Approximately up to 21 monthsPopulation: All confirmed responders per IRC
DOR is defined as the time from first confirmed response (CR or PR) per IRC assessment to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Median values of DOR, along with two-sided 95% CI in each treatment group will be computed based on a log-log transformation method.
Outcome measures
| Measure |
Nivolumab, 3 mg/kg
n=17 Participants
Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
|
|---|---|
|
Duration of Response (DOR) as Assessed by Independent Radiology Review Committee (IRC)
|
NA Months
Interval 8.31 to
the median and its 95% upper limit were not reached per the Kaplan-Meier method, as the probability in response was still above 50%
|
Adverse Events
Nivolumab, 3 mg/kg
Serious events: 88 serious events
Other events: 110 other events
Deaths: 108 deaths
Serious adverse events
| Measure |
Nivolumab, 3 mg/kg
n=117 participants at risk
Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Cardiac disorders
Cardiac tamponade
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Cardiac disorders
Myocardial infarction
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Cardiac disorders
Pericarditis
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Cardiac disorders
Ventricular tachycardia
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Endocrine disorders
Adrenal insufficiency
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
3/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
2/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
2/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Gastrointestinal disorders
Haematemesis
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Gastrointestinal disorders
Vomiting
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
General disorders
Chest pain
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
General disorders
Pain
|
2.6%
3/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
General disorders
Performance status decreased
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
General disorders
Pyrexia
|
1.7%
2/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
General disorders
Sudden death
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Immune system disorders
Anaphylactic reaction
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Immune system disorders
Hypersensitivity
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Infections and infestations
Bronchitis
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Infections and infestations
Cellulitis
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Infections and infestations
Diverticulitis
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Infections and infestations
Herpes zoster
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Infections and infestations
Meningitis
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Infections and infestations
Pneumonia
|
8.5%
10/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Infections and infestations
Pulmonary sepsis
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Infections and infestations
Sepsis
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Infections and infestations
Septic shock
|
1.7%
2/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Infections and infestations
Wound infection
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Investigations
C-reactive protein increased
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Metabolism and nutrition disorders
Dehydration
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.1%
6/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.7%
2/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
28.2%
33/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Nervous system disorders
Brain oedema
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Nervous system disorders
Cognitive disorder
|
1.7%
2/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Nervous system disorders
Headache
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Nervous system disorders
Ischaemic stroke
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Nervous system disorders
Motor dysfunction
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Nervous system disorders
Peripheral nerve paresis
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Nervous system disorders
Seizure
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Nervous system disorders
Syncope
|
1.7%
2/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Psychiatric disorders
Confusional state
|
1.7%
2/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Renal and urinary disorders
Acute kidney injury
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.1%
6/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.5%
10/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.4%
4/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
2/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
4/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.7%
2/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.1%
6/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
2/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.7%
2/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.6%
3/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Vascular disorders
Deep vein thrombosis
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Vascular disorders
Embolism
|
0.85%
1/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Vascular disorders
Hypotension
|
1.7%
2/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Vascular disorders
Superior vena cava syndrome
|
1.7%
2/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
Other adverse events
| Measure |
Nivolumab, 3 mg/kg
n=117 participants at risk
Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.8%
22/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
14/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.0%
7/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Gastrointestinal disorders
Constipation
|
26.5%
31/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Gastrointestinal disorders
Diarrhoea
|
20.5%
24/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Gastrointestinal disorders
Dry mouth
|
6.8%
8/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Gastrointestinal disorders
Nausea
|
31.6%
37/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Gastrointestinal disorders
Vomiting
|
20.5%
24/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
General disorders
Asthenia
|
20.5%
24/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
General disorders
Chest pain
|
6.8%
8/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
General disorders
Fatigue
|
53.0%
62/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
General disorders
Mucosal inflammation
|
6.0%
7/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
General disorders
Oedema peripheral
|
13.7%
16/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
General disorders
Pain
|
8.5%
10/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
General disorders
Pyrexia
|
20.5%
24/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Infections and infestations
Bronchitis
|
9.4%
11/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Infections and infestations
Pneumonia
|
6.0%
7/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Infections and infestations
Sinusitis
|
6.0%
7/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Injury, poisoning and procedural complications
Fall
|
6.0%
7/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Investigations
Blood creatinine increased
|
8.5%
10/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Investigations
Weight decreased
|
16.2%
19/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Metabolism and nutrition disorders
Decreased appetite
|
39.3%
46/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Metabolism and nutrition disorders
Dehydration
|
8.5%
10/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.7%
9/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.5%
10/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.1%
6/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.0%
7/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.5%
10/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.5%
10/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.1%
6/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.5%
24/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
14/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.8%
8/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.7%
9/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
13/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
9/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Nervous system disorders
Dizziness
|
12.0%
14/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Nervous system disorders
Headache
|
9.4%
11/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Nervous system disorders
Neuropathy peripheral
|
6.0%
7/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Psychiatric disorders
Insomnia
|
6.0%
7/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
34.2%
40/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
38.5%
45/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.8%
8/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.0%
7/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.1%
6/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.0%
7/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.0%
14/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.5%
17/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Vascular disorders
Hypertension
|
6.8%
8/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
|
Vascular disorders
Hypotension
|
7.7%
9/117 • From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER