Trial Outcomes & Findings for Study of Nivolumab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) That Have Either Failed or Are Not Eligible for Autologous Stem Cell Transplant (CheckMate 139) (NCT NCT02038933)
NCT ID: NCT02038933
Last Updated: 2021-10-14
Results Overview
ORR is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Remission (CR) or Partial Remission (PR), according to the 2007 revised International Working Group (IWG) Criteria for Malignant Lymphoma, , based on IRRC assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assesed up to April 2016, approximately 25 months)
Results posted on
2021-10-14
Participant Flow
121 participants entered the treatment period.
Participant milestones
| Measure |
Nivolumab 3mg/kg
Nivolumab 3mg/kg IV Q2W for participants who failed autologous stem cell transplant (ASCT) or who were ineligible for ASCT
|
|---|---|
|
Overall Study
STARTED
|
121
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
121
|
Reasons for withdrawal
| Measure |
Nivolumab 3mg/kg
Nivolumab 3mg/kg IV Q2W for participants who failed autologous stem cell transplant (ASCT) or who were ineligible for ASCT
|
|---|---|
|
Overall Study
Disease progression
|
104
|
|
Overall Study
Study drug toxicity
|
6
|
|
Overall Study
Adverse event unrelated to study drug
|
6
|
|
Overall Study
Participant request to discontinue treatment
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Other reasons
|
2
|
Baseline Characteristics
Study of Nivolumab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) That Have Either Failed or Are Not Eligible for Autologous Stem Cell Transplant (CheckMate 139)
Baseline characteristics by cohort
| Measure |
ASCT-failed
n=87 Participants
Participants who failed Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
ASCT-ineligible
n=34 Participants
Participants who were ineligible for Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
41 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 10.94 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 12.98 • n=7 Participants
|
61.1 years
STANDARD_DEVIATION 11.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assesed up to April 2016, approximately 25 months)Population: All treated participants
ORR is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Remission (CR) or Partial Remission (PR), according to the 2007 revised International Working Group (IWG) Criteria for Malignant Lymphoma, , based on IRRC assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites
Outcome measures
| Measure |
ASCT-failed
n=87 Participants
Participants who failed Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
ASCT-ineligible
n=34 Participants
Participants who were ineligible for Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
|---|---|---|
|
Objective Response Rate (ORR) Per Independent Radiologic Review Committee (IRRC) Assessment
|
10.3 Percent of participants
Interval 4.8 to 18.7
|
2.9 Percent of participants
Interval 0.1 to 15.3
|
SECONDARY outcome
Timeframe: From date of first response to the date of documented disease progression or death, whichever occurs first (up to approximately 18 months)Population: All participants with CR or PR
DOR is defined as the time from first response (Complete Response (CR) or Partial Response (PR)) to the date of initial objectively documented progression as determined using the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites.
Outcome measures
| Measure |
ASCT-failed
n=9 Participants
Participants who failed Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
ASCT-ineligible
n=1 Participants
Participants who were ineligible for Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
|---|---|---|
|
Duration of Response (DOR)
|
11.43 Months
Interval 2.53 to 17.15
|
8.34 Months
95% CI was not calculated as there was only one participant analyzed in this arm.
|
SECONDARY outcome
Timeframe: From date of first dose to study completion (up to approximately 78 months)Population: All treated participants
Complete Remission Rate is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Response (CR) according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan.
Outcome measures
| Measure |
ASCT-failed
n=87 Participants
Participants who failed Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
ASCT-ineligible
n=34 Participants
Participants who were ineligible for Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
|---|---|---|
|
Complete Remission Rate
|
3.4 Percent of participants
Interval 0.7 to 9.7
|
0 Percent of participants
Interval 0.0 to 10.3
|
SECONDARY outcome
Timeframe: From time of first documentation of CR to the date of initial documented disease progression or death due to any cause, whichever occurs first (up approximately 14 months)Population: All participants with CR
The duration of Complete Remission is defined as the time from first documentation of Complete Response (CR) (which is the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow \[if required\], whichever occurs later) to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first. CR= Disappearance of all evidence of disease, confirmed by PET scan.
Outcome measures
| Measure |
ASCT-failed
n=3 Participants
Participants who failed Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
ASCT-ineligible
Participants who were ineligible for Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
|---|---|---|
|
Duration of Complete Remission
|
NA Months
Interval 11.17 to
Median and Upper Limit were not reached due to insufficient number of participants with CR
|
—
|
SECONDARY outcome
Timeframe: From date of first dose to study completion (up to approximately 78 months)Population: All treated participants
Partial Remission rate is defined as the percentage of participants with a Best Overall Response (BOR) of Partial Response (PR) according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment. PR= Regression of measurable disease and no emergence of new sites.
Outcome measures
| Measure |
ASCT-failed
n=87 Participants
Participants who failed Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
ASCT-ineligible
n=34 Participants
Participants who were ineligible for Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
|---|---|---|
|
Partial Remission Rate
|
6.9 Percent of participants
Interval 2.6 to 14.4
|
2.9 Percent of participants
Interval 0.1 to 15.3
|
SECONDARY outcome
Timeframe: From date of first documentation of PR to date of disease progression or death due to any cause, whichever occurs first (up to approximately 12 months)Population: All participants with PR
Duration of Partial Remission is defined as the time from first documentation of Partial Response (PR) to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first. PR= Regression of measurable disease and no emergence of new sites.
Outcome measures
| Measure |
ASCT-failed
n=6 Participants
Participants who failed Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
ASCT-ineligible
n=1 Participants
Participants who were ineligible for Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
|---|---|---|
|
Duration of Partial Remission
|
6.64 Months
Interval 2.4 to 11.4
|
8.34 Months
Interval 8.34 to 8.34
|
SECONDARY outcome
Timeframe: From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (up to approximately 2 months)Population: All treated participants
Progression Free Survival (PFS) is defined as the time from first dosing date to the date of the first documented progression, as determined by an Independent Radiology Review Committee (IRRC) according to the 2007 revised IWG Criteria for Malignant Lymphoma, or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
ASCT-failed
n=87 Participants
Participants who failed Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
ASCT-ineligible
n=34 Participants
Participants who were ineligible for Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
|---|---|---|
|
Progression Free Survival
|
1.87 Months
Interval 1.71 to 1.87
|
1.41 Months
Interval 1.15 to 1.81
|
SECONDARY outcome
Timeframe: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (up to approximately 30 months)Population: All treated participants
ORR is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), according to investigator assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites.
Outcome measures
| Measure |
ASCT-failed
n=87 Participants
Participants who failed Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
ASCT-ineligible
n=34 Participants
Participants who were ineligible for Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W
|
|---|---|---|
|
Objective Response Rate (ORR) Per Investigator Assessment
|
19.5 Percent of participants
Interval 11.8 to 29.4
|
2.9 Percent of participants
Interval 0.1 to 15.3
|
Adverse Events
NIVOLUMAB 3 mg/kg
Serious events: 83 serious events
Other events: 109 other events
Deaths: 98 deaths
Serious adverse events
| Measure |
NIVOLUMAB 3 mg/kg
n=121 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Abdominal lymphadenopathy
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
2/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.5%
3/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
2/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Cardiac disorders
Atrial fibrillation
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Cardiac disorders
Myocardial infarction
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Eye disorders
Eye swelling
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Eye disorders
Uveitis
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
4.1%
5/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Gastrointestinal disorders
Ascites
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
3/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
2/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Gastrointestinal disorders
Melaena
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
1.7%
2/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
2/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
General disorders
Asthenia
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
General disorders
Facial pain
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
General disorders
General physical health deterioration
|
2.5%
3/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
General disorders
Localised oedema
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
General disorders
Oedema peripheral
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
General disorders
Pyrexia
|
3.3%
4/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
General disorders
Swelling face
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Infections and infestations
Cellulitis
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Infections and infestations
Febrile infection
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Infections and infestations
Herpes zoster
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Infections and infestations
Kidney infection
|
1.7%
2/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Infections and infestations
Neutropenic sepsis
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Infections and infestations
Peritonitis
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Infections and infestations
Pneumonia
|
5.8%
7/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Infections and infestations
Pneumonia bacterial
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Infections and infestations
Sepsis
|
1.7%
2/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Infections and infestations
Septic shock
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Infections and infestations
Sinusitis
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Infections and infestations
Tonsillitis
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Infections and infestations
Urinary tract infection
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Investigations
Transaminases increased
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.0%
6/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.7%
2/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
1.7%
2/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Musculoskeletal and connective tissue disorders
Morphoea
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
6.6%
8/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
24.8%
30/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
1.7%
2/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Nervous system disorders
Encephalopathy
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Nervous system disorders
Headache
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Nervous system disorders
Presyncope
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Psychiatric disorders
Confusional state
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Psychiatric disorders
Hallucination, visual
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
4.1%
5/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Renal and urinary disorders
Renal impairment
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
2/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
2/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.3%
4/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.83%
1/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Vascular disorders
Hypotension
|
1.7%
2/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
Other adverse events
| Measure |
NIVOLUMAB 3 mg/kg
n=121 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.4%
32/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.0%
17/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.5%
20/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
14.0%
17/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Gastrointestinal disorders
Constipation
|
22.3%
27/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
20.7%
25/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Gastrointestinal disorders
Dry mouth
|
5.8%
7/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Gastrointestinal disorders
Nausea
|
33.9%
41/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Gastrointestinal disorders
Stomatitis
|
5.8%
7/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Gastrointestinal disorders
Vomiting
|
19.0%
23/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
General disorders
Asthenia
|
6.6%
8/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
General disorders
Fatigue
|
40.5%
49/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
General disorders
Oedema peripheral
|
14.0%
17/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
General disorders
Pyrexia
|
24.0%
29/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
7/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
9/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Investigations
Aspartate aminotransferase increased
|
6.6%
8/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Investigations
Blood creatinine increased
|
10.7%
13/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.0%
23/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.4%
9/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.4%
9/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
10/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.6%
8/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.7%
19/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.7%
13/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.7%
13/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Nervous system disorders
Headache
|
11.6%
14/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Psychiatric disorders
Anxiety
|
7.4%
9/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Psychiatric disorders
Insomnia
|
9.1%
11/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
22/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.7%
19/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.6%
8/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
9/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.2%
16/121 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER