Trial Outcomes & Findings for A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer (NCT NCT03785925)
NCT ID: NCT03785925
Last Updated: 2023-03-28
Results Overview
To evaluate the anti-tumor activity of NKTR-214 in combination with nivolumab by assessing the ORR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per blinded independent central review (BICR) in patients whose tumors have low programmed cell death ligand 1 (PD-L1) expression. ORR was defined as the percentage of patients with confirmed objective response of Complete Response (CR) or Partial Response (PR) on or before the first progressive disease and any subsequent anticancer therapy. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
192 participants
Primary outcome timeframe
Tumor assessments were performed at baseline and every 9 weeks from Cycle 1 Day 1 for the first 12 months, and then every 12 weeks as indicated in the Schedule of Events, up to approximately 27 months
Results posted on
2023-03-28
Participant Flow
192 patients were enrolled. Two patients withdrew consent before treatment. Two patients received Gemcitabine + Carboplatin under protocol amendment 2.0. The noncomparative, reference chemotherapy arm of gemcitabine + carboplatin was subsequently eliminated in protocol amendment 3.0. These four patients were excluded from the analysis.
Participant milestones
| Measure |
Combination of Bempegaldesleukin (NKTR-214) + Nivolumab
Participants received bempegaldesleukin (NKTR-214) at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.
The Treated Population included 188 patients; from these, 123 had tumors with low PD-L1 expression, 59 had tumors with high PD-L1 expression, and 6 had unknown PD-L1 expression.
|
|---|---|
|
Overall Study
STARTED
|
188
|
|
Overall Study
COMPLETED
|
172
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Combination of Bempegaldesleukin (NKTR-214) + Nivolumab
Participants received bempegaldesleukin (NKTR-214) at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.
The Treated Population included 188 patients; from these, 123 had tumors with low PD-L1 expression, 59 had tumors with high PD-L1 expression, and 6 had unknown PD-L1 expression.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
15
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer
Baseline characteristics by cohort
| Measure |
Combination of Bempegaldesleukin (NKTR-214) + Nivolumab
n=188 Participants
Participants received bempegaldesleukin (NKTR-214) at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.
|
|---|---|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 8.21 • n=93 Participants
|
|
Age, Customized
Age < 65
|
37 Participants
n=93 Participants
|
|
Age, Customized
Age 65-84
|
141 Participants
n=93 Participants
|
|
Age, Customized
Age 85 and Over
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
155 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
171 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=93 Participants
|
|
Region of Enrollment
Argentina
|
14 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=93 Participants
|
|
Region of Enrollment
Portugal
|
2 participants
n=93 Participants
|
|
Region of Enrollment
Russia
|
21 participants
n=93 Participants
|
|
Region of Enrollment
Spain
|
27 participants
n=93 Participants
|
|
Region of Enrollment
Greece
|
10 participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=93 Participants
|
|
Region of Enrollment
Netherlands
|
6 participants
n=93 Participants
|
|
Region of Enrollment
Turkey
|
8 participants
n=93 Participants
|
|
Region of Enrollment
Belgium
|
5 participants
n=93 Participants
|
|
Region of Enrollment
Finland
|
2 participants
n=93 Participants
|
|
Region of Enrollment
Italy
|
8 participants
n=93 Participants
|
|
Region of Enrollment
Mexico
|
1 participants
n=93 Participants
|
|
Region of Enrollment
Israel
|
11 participants
n=93 Participants
|
|
Region of Enrollment
Australia
|
14 participants
n=93 Participants
|
|
Region of Enrollment
France
|
9 participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=93 Participants
|
|
ECOG Performance Status
ECOG PS 0
|
64 Participants
n=93 Participants
|
|
ECOG Performance Status
ECOG PS 1
|
73 Participants
n=93 Participants
|
|
ECOG Performance Status
ECOG PS 2
|
51 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Tumor assessments were performed at baseline and every 9 weeks from Cycle 1 Day 1 for the first 12 months, and then every 12 weeks as indicated in the Schedule of Events, up to approximately 27 monthsPopulation: The primary endpoint of ORR per RECIST 1.1 by BICR was evaluated in the Treated PD-L1 Low Population (123 patients). The Treated Population included 188 patients who were enrolled and received at least one full (or partial dose) of NKTR-214 or nivolumab. PD-L1 Low: Patients in the Treated Population whose tumors had low PD-L1 expression (defined as Combined Positive Score \[CPS\] \< 10). From the 188 patients, 123 had tumors with low PD-L1 expression.
To evaluate the anti-tumor activity of NKTR-214 in combination with nivolumab by assessing the ORR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per blinded independent central review (BICR) in patients whose tumors have low programmed cell death ligand 1 (PD-L1) expression. ORR was defined as the percentage of patients with confirmed objective response of Complete Response (CR) or Partial Response (PR) on or before the first progressive disease and any subsequent anticancer therapy. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
PD-L1 Low
n=123 Participants
ORR per RECIST 1.1 by BICR in PD-L1 Low Patients
|
Combination of Bempegaldesleukin (NKTR-214) + Nivolumab (PD-L1 Low Population)
Arm Group Description: Participants received bempegaldesleukin (NKTR-214) at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.
|
|---|---|---|
|
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Per Blinded Independent Central Review (BICR) in Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression
|
22 Participants
|
—
|
SECONDARY outcome
Timeframe: Tumor assessments were performed at baseline and every 9 weeks from Cycle 1 Day 1 for the first 12 months, and then every 12 weeks as indicated in the Schedule of Events, up to approximately 27 months.Population: The secondary endpoint of ORR per RECIST 1.1 by BICR was evaluated in the Treated Population (188 patients).
To evaluate the anti-tumor activity of NKTR-214 in combination with nivolumab by assessing the ORR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per blinded independent central review (BICR) in all treated patients. ORR was defined as the percentage of patients with confirmed objective response of Complete Response (CR) or Partial Response (PR) on or before the first progressive disease and any subsequent anticancer therapy. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
PD-L1 Low
n=188 Participants
ORR per RECIST 1.1 by BICR in PD-L1 Low Patients
|
Combination of Bempegaldesleukin (NKTR-214) + Nivolumab (PD-L1 Low Population)
Arm Group Description: Participants received bempegaldesleukin (NKTR-214) at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.
|
|---|---|---|
|
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Per Blinded Independent Central Review (BICR) in All Treated Patients
|
37 Participants
|
—
|
SECONDARY outcome
Timeframe: Tumor assessments were performed at baseline and every 9 weeks from Cycle 1 Day 1 for the first 12 months, and then every 12 weeks as indicated in the Schedule of Events, up to approximately 27 months.Population: All Treated Population who had a confirmed Complete Response (CR) or Partial Response (PR) per RECIST 1.1. Treated PD-L1 Low: Patients in the Treated Population whose tumors had low PD-L1 expression (defined as Combined Positive Score \[CPS\] \< 10).
To evaluate the effect of NKTR 214 in combination with nivolumab by assessing DOR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per blinded independent central review (BICR) in all treated patients and patients whose tumors have low PD-L1 expression. DOR is defined for patients who have a confirmed Complete Response (CR) or Partial Response (PR) as the date from first documented CR or PR per RECIST 1.1 to the date of documentation of disease progression as assessed by BICR or death due to any cause, whichever is earlier. Patients who do not have disease progression or die will be censored on the date of their last evaluable tumor assessment.
Outcome measures
| Measure |
PD-L1 Low
n=37 Participants
ORR per RECIST 1.1 by BICR in PD-L1 Low Patients
|
Combination of Bempegaldesleukin (NKTR-214) + Nivolumab (PD-L1 Low Population)
n=22 Participants
Arm Group Description: Participants received bempegaldesleukin (NKTR-214) at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.
|
|---|---|---|
|
Duration of Response (DOR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Per Blinded Independent Central Review (BICR) in in All Treated Patients and Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression
|
13.4 Months
Interval 8.2 to
NA = 95% CI upper limit could not be estimated due to an insufficient number of participants
|
13.4 Months
Interval 6.2 to
NA = 95% CI upper limit could not be estimated due to an insufficient number of participants
|
SECONDARY outcome
Timeframe: Tumor assessments were performed at baseline and every 9 weeks from Cycle 1 Day 1 for the first 12 months, and then every 12 weeks as indicated in the Schedule of Events, up to approximately 27 months.Population: The All Treated Population included 188 patients who were enrolled and received at least one full (or partial dose) of NKTR-214 or nivolumab. Treated PD-L1 Low: Patients in the Treated Population whose tumors had low PD-L1 expression (defined as Combined Positive Score \[CPS\] \< 10). From the 188 patients, 123 had tumors with low PD-L1 expression.
To evaluate the anti-tumor activity of NKTR-214 in combination with nivolumab by assessing the ORR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Investigator Assessment in All Treated Patients and Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression. ORR was defined as the percentage of patients with confirmed objective response of Complete Response (CR) or Partial Response (PR) on or before the first progressive disease and any subsequent anticancer therapy.
Outcome measures
| Measure |
PD-L1 Low
n=188 Participants
ORR per RECIST 1.1 by BICR in PD-L1 Low Patients
|
Combination of Bempegaldesleukin (NKTR-214) + Nivolumab (PD-L1 Low Population)
n=123 Participants
Arm Group Description: Participants received bempegaldesleukin (NKTR-214) at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.
|
|---|---|---|
|
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator in All Treated Patients and Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression
|
36 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Tumor assessments were performed at baseline and every 9 weeks from Cycle 1 Day 1 for the first 12 months, and then every 12 weeks as indicated in the Schedule of Events, up to approximately 27 months.Population: All Treated Population who had a confirmed Complete Response (CR) or Partial Response (PR) per RECIST 1.1. Treated PD-L1 Low: Patients in the Treated Population whose tumors had low PD-L1 expression (defined as Combined Positive Score \[CPS\] \< 10).
To evaluate the effect of NKTR 214 in combination with nivolumab by assessing DOR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Investigator Assessment in all treated patients and patients whose tumors have low PD-L1 expression. DOR is defined for patients who have a confirmed Complete Response (CR) or Partial Response (PR) as the date from first documented CR or PR per RECIST 1.1 to the date of documentation of disease progression as assessed by BICR or death due to any cause, whichever is earlier. Patients who do not have disease progression or die will be censored on the date of their last evaluable tumor assessment.
Outcome measures
| Measure |
PD-L1 Low
n=36 Participants
ORR per RECIST 1.1 by BICR in PD-L1 Low Patients
|
Combination of Bempegaldesleukin (NKTR-214) + Nivolumab (PD-L1 Low Population)
n=20 Participants
Arm Group Description: Participants received bempegaldesleukin (NKTR-214) at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.
|
|---|---|---|
|
Duration of Response (DOR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator in All Treated Patients and Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression
|
15.9 Months
Interval 10.7 to
NA = 95% CI upper limit could not be estimated due to an insufficient number of participants
|
14.3 Months
Interval 8.2 to
NA = 95% CI upper limit could not be estimated due to an insufficient number of participants
|
Adverse Events
Combination of Bempegaldesleukin (NKTR-214) + Nivolumab
Serious events: 98 serious events
Other events: 185 other events
Deaths: 127 deaths
Serious adverse events
| Measure |
Combination of Bempegaldesleukin (NKTR-214) + Nivolumab
n=188 participants at risk
Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.
Bempegaldesleukin: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
|---|---|
|
Infections and infestations
Urinary tract infection
|
6.4%
12/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.8%
9/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Renal and urinary disorders
Haematuria
|
3.7%
7/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
6/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
General disorders
Pyrexia
|
2.7%
5/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Pneumonia
|
2.1%
4/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Urosepsis
|
2.1%
4/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Corona virus infection
|
1.6%
3/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
General disorders
Fatigue
|
1.6%
3/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
3/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
3/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
1.1%
2/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.1%
2/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Renal and urinary disorders
Nephritis
|
1.1%
2/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
2/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
General disorders
General physical health deterioration
|
1.1%
2/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
2/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
2/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Cardiac disorders
Cardiac failure
|
1.1%
2/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Cardiac disorders
Myocarditis
|
1.1%
2/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Vascular disorders
Deep vein thrombosis
|
1.1%
2/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Vascular disorders
Hypotension
|
1.1%
2/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Vascular disorders
Peripheral ischaemia
|
1.1%
2/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
2/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
2/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Bacterial sepsis
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Gastroenteritis viral
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Herpes zoster
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Lung infection
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Peritonitis
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Pharyngitis
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Pyelonephritis
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Pyelonephritis acute
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Renal abscess
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Sepsis
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Spinal cord infection
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Vascular device infection
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Renal and urinary disorders
Kidney congestion
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Renal and urinary disorders
Renal failure
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Renal and urinary disorders
Urinary retention
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Renal and urinary disorders
Urinary tract discomfort
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Ileus
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
General disorders
Asthenia
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
General disorders
Sudden death
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Nervous system disorders
Cerebral infarction
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Nervous system disorders
Cerebral microembolism
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Psychiatric disorders
Confusional state
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Psychiatric disorders
Delirium
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Endocrine disorders
Hypophysitis
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Immune system disorders
Drug hypersensitivity
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Product Issues
Device occlusion
|
0.53%
1/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
Other adverse events
| Measure |
Combination of Bempegaldesleukin (NKTR-214) + Nivolumab
n=188 participants at risk
Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.
Bempegaldesleukin: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
|---|---|
|
General disorders
Pyrexia
|
43.6%
82/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
General disorders
Fatigue
|
30.9%
58/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.9%
58/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
30.3%
57/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
29.8%
56/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Nausea
|
28.7%
54/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Constipation
|
23.4%
44/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.9%
43/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
21.3%
40/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Infections and infestations
Urinary tract infection
|
20.7%
39/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
General disorders
Asthenia
|
19.1%
36/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Vomiting
|
18.6%
35/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.6%
35/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
General disorders
Oedema peripheral
|
17.0%
32/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Renal and urinary disorders
Haematuria
|
16.5%
31/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Endocrine disorders
Hypothyroidism
|
14.9%
28/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
General disorders
Chills
|
14.4%
27/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
13.8%
26/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Investigations
Blood creatinine increased
|
13.3%
25/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
General disorders
Influenza like illness
|
12.8%
24/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.2%
23/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Nervous system disorders
Dizziness
|
11.7%
22/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Vascular disorders
Hypotension
|
11.7%
22/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.2%
21/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.6%
20/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.1%
19/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Nervous system disorders
Headache
|
10.1%
19/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.0%
17/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Endocrine disorders
Hyperthyroidism
|
9.0%
17/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
15/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
8.0%
15/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.0%
15/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Psychiatric disorders
Insomnia
|
8.0%
15/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.4%
14/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Investigations
Weight decreased
|
7.4%
14/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.9%
13/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.9%
13/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.9%
13/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.4%
12/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.4%
12/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.4%
12/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Gastrointestinal disorders
Dry mouth
|
5.9%
11/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Investigations
Amylase increased
|
5.9%
11/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
11/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Vascular disorders
Hypertension
|
5.9%
11/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
General disorders
Face oedema
|
5.3%
10/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
10/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
10/188 • AEs were reported from the time of first study drug(s) administration until 100 days after the last dose of all study drug(s), up to a maximum of approximately 27 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There are restrictions to the PI's rights to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER