NCT02983045 · ADVERSE EVENTS

Adverse events

A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors · Source last updated 2023-03-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: 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 2.5 years.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part 1 Dose Escalation Cohort 1: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (240 mg) q2w NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 240 mg nivolumab q2w.	2 / 4	4 / 4	2 / 4
Part 1 Dose Escalation Cohort 2: NKTR-214 (0.006 mg/kg) q2w + Nivolumab (240 mg) q2w NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.006 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.	0 / 3	3 / 3	1 / 3
Part 1 Dose Escalation Cohort 3: NKTR-214 (0.003 mg/kg) q2w + Nivolumab (240 mg) q2w NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.003 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.	1 / 3	3 / 3	2 / 3
Part 1 Dose Escalation Cohort 4: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.	9 / 25	25 / 25	10 / 25
Part 1 Dose Escalation Cohort 5: NKTR-214 (0.009 mg/kg) q3w + Nivolumab (360 mg) q3w NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.009 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.	2 / 3	3 / 3	1 / 3
Part 2 Dose Expansion: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w In this Part 2 of the study, the patients will receive a combination of NKTR-214 + nivolumab at the RP2D (NKTR 214 0.006 mg/kg q3w + nivolumab 360 mg q3w) with or without chemotherapy.	213 / 476	468 / 476	291 / 476
Part 3 Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 1, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 360 mg flat dose q3w + ipilimumab at 1 mg/kg q6w.	6 / 10	10 / 10	2 / 10
Part 3 Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 2, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 1 mg/kg q3w + ipilimumab at 3 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.	5 / 8	8 / 8	3 / 8
Part 3 Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 3, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 3 mg/kg q3w + ipilimumab at 1 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.	2 / 6	6 / 6	1 / 6
Part 4 Dose Expansion of NKTR-214 + Nivolumab + Ipilimumab Experimental Combination of NKTR-214 + nivolumab + ipilimumab. Combination of NKTR-214 + nivolumab: Combination of NKTR-214 + nivolumab +ipilimumab administered at the RP2D dose/schedule.	8 / 19	19 / 19	5 / 19

Group identifiers: EG000: Part 1 Dose Escalation Cohort 1: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (240 mg) q2w · EG001: Part 1 Dose Escalation Cohort 2: NKTR-214 (0.006 mg/kg) q2w + Nivolumab (240 mg) q2w · EG002: Part 1 Dose Escalation Cohort 3: NKTR-214 (0.003 mg/kg) q2w + Nivolumab (240 mg) q2w · EG003: Part 1 Dose Escalation Cohort 4: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w · EG004: Part 1 Dose Escalation Cohort 5: NKTR-214 (0.009 mg/kg) q3w + Nivolumab (360 mg) q3w · EG005: Part 2 Dose Expansion: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w · EG006: Part 3 Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab · EG007: Part 3 Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab · EG008: Part 3 Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab · EG009: Part 4 Dose Expansion of NKTR-214 + Nivolumab + Ipilimumab

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
14
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
19
term
Dyspnoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
8
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Pleural effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
6
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Pneumonitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
3
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
19
term
Pulmonary embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
3
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Chronic obstructive pulmonary disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
3
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Respiratory failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Haemoptysis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Hypoxia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Pneumothorax
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Pulmonary oedema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Acute respiratory failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Bronchial obstruction

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
4
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
19
num At Risk
25
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
241
num At Risk
476
group Id
EG006
num Affected
9
num At Risk
10
group Id
EG007
num Affected
5
num At Risk
8
group Id
EG008
num Affected
6
num At Risk
6
group Id
EG009
num Affected
15
num At Risk
19
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
4
num At Risk
4
group Id
EG001
num Affected
3
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
13
num At Risk
25
group Id
EG004
num Affected
3
num At Risk
3
group Id
EG005
num Affected
228
num At Risk
476
group Id
EG006
num Affected
7
num At Risk
10
group Id
EG007
num Affected
3
num At Risk
8
group Id
EG008
num Affected
5
num At Risk
6
group Id
EG009
num Affected
10
num At Risk
19
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
3
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
14
num At Risk
25
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
126
num At Risk
476
group Id
EG006
num Affected
6
num At Risk
10
group Id
EG007
num Affected
6
num At Risk
8
group Id
EG008
num Affected
6
num At Risk
6
group Id
EG009
num Affected
13
num At Risk
19
term
Influenza like illness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
3
num At Risk
4
group Id
EG001
num Affected
3
num At Risk
3
group Id
EG002
num Affected
3
num At Risk
3
group Id
EG003
num Affected
16
num At Risk
25
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
115
num At Risk
476
group Id
EG006
num Affected
5
num At Risk
10
group Id
EG007
num Affected
3
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
7
num At Risk
19
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
11
num At Risk
25
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
90
num At Risk
476
group Id
EG006
num Affected
3
num At Risk
10
group Id
EG007
num Affected
3
num At Risk
8
group Id
EG008
num Affected
4
num At Risk
6
group Id
EG009
num Affected
5
num At Risk
19
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
25
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
70
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
5
num At Risk
25
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
27
num At Risk
476
group Id
EG006
num Affected
2
num At Risk
10
group Id
EG007
num Affected
2
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
2
num At Risk
19
term
Face oedema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
24
num At Risk
476
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Malaise
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
4
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
23
num At Risk
476
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
8
group Id
EG008
num Affected
2
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
20
num At Risk
476
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
17
num At Risk
476
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Peripheral swelling
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
25
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
16
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Mucosal inflammation

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
4
description
NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 240 mg nivolumab q2w.
id
EG000
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Part 1 Dose Escalation Cohort 1: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (240 mg) q2w
deaths Num Affected
1
deaths Num At Risk
3
description
NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.006 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Part 1 Dose Escalation Cohort 2: NKTR-214 (0.006 mg/kg) q2w + Nivolumab (240 mg) q2w
deaths Num Affected
2
deaths Num At Risk
3
description
NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.003 mg/kg administered every 2 weeks (q2w) in combination with 240 mg nivolumab q2w.
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Part 1 Dose Escalation Cohort 3: NKTR-214 (0.003 mg/kg) q2w + Nivolumab (240 mg) q2w
deaths Num Affected
10
deaths Num At Risk
25
description
NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.
id
EG003
other Num Affected
25
other Num At Risk
25
serious Num Affected
9
serious Num At Risk
25
title
Part 1 Dose Escalation Cohort 4: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w
deaths Num Affected
1
deaths Num At Risk
3
description
NKTR-214 in escalating doses combined with one of the two proposed doses of nivolumab. The goal of this dose escalation Part 1 of the study is to find the RP2D. Patients will receive NKTR-214 at 0.009 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.
id
EG004
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Part 1 Dose Escalation Cohort 5: NKTR-214 (0.009 mg/kg) q3w + Nivolumab (360 mg) q3w
deaths Num Affected
291
deaths Num At Risk
476
description
In this Part 2 of the study, the patients will receive a combination of NKTR-214 + nivolumab at the RP2D (NKTR 214 0.006 mg/kg q3w + nivolumab 360 mg q3w) with or without chemotherapy.
id
EG005
other Num Affected
468
other Num At Risk
476
serious Num Affected
213
serious Num At Risk
476
title
Part 2 Dose Expansion: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w
deaths Num Affected
2
deaths Num At Risk
10
description
In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 1, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 360 mg flat dose q3w + ipilimumab at 1 mg/kg q6w.
id
EG006
other Num Affected
10
other Num At Risk
10
serious Num Affected
6
serious Num At Risk
10
title
Part 3 Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab
deaths Num Affected
3
deaths Num At Risk
8
description
In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 2, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 1 mg/kg q3w + ipilimumab at 3 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.
id
EG007
other Num Affected
8
other Num At Risk
8
serious Num Affected
5
serious Num At Risk
8
title
Part 3 Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab
deaths Num Affected
1
deaths Num At Risk
6
description
In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 3, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 3 mg/kg q3w + ipilimumab at 1 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.
id
EG008
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Part 3 Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab
deaths Num Affected
5
deaths Num At Risk
19
description
Experimental Combination of NKTR-214 + nivolumab + ipilimumab. Combination of NKTR-214 + nivolumab: Combination of NKTR-214 + nivolumab +ipilimumab administered at the RP2D dose/schedule.
id
EG009
other Num Affected
19
other Num At Risk
19
serious Num Affected
8
serious Num At Risk
19
title
Part 4 Dose Expansion of NKTR-214 + Nivolumab + Ipilimumab

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
4
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
19
num At Risk
25
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
241
num At Risk
476
group Id
EG006
num Affected
9
num At Risk
10
group Id
EG007
num Affected
5
num At Risk
8
group Id
EG008
num Affected
6
num At Risk
6
group Id
EG009
num Affected
15
num At Risk
19
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
4
num At Risk
4
group Id
EG001
num Affected
3
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
13
num At Risk
25
group Id
EG004
num Affected
3
num At Risk
3
group Id
EG005
num Affected
228
num At Risk
476
group Id
EG006
num Affected
7
num At Risk
10
group Id
EG007
num Affected
3
num At Risk
8
group Id
EG008
num Affected
5
num At Risk
6
group Id
EG009
num Affected
10
num At Risk
19
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
3
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
14
num At Risk
25
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
126
num At Risk
476
group Id
EG006
num Affected
6
num At Risk
10
group Id
EG007
num Affected
6
num At Risk
8
group Id
EG008
num Affected
6
num At Risk
6
group Id
EG009
num Affected
13
num At Risk
19
term
Influenza like illness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
3
num At Risk
4
group Id
EG001
num Affected
3
num At Risk
3
group Id
EG002
num Affected
3
num At Risk
3
group Id
EG003
num Affected
16
num At Risk
25
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
115
num At Risk
476
group Id
EG006
num Affected
5
num At Risk
10
group Id
EG007
num Affected
3
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
7
num At Risk
19
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
11
num At Risk
25
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
90
num At Risk
476
group Id
EG006
num Affected
3
num At Risk
10
group Id
EG007
num Affected
3
num At Risk
8
group Id
EG008
num Affected
4
num At Risk
6
group Id
EG009
num Affected
5
num At Risk
19
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
25
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
70
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
5
num At Risk
25
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
27
num At Risk
476
group Id
EG006
num Affected
2
num At Risk
10
group Id
EG007
num Affected
2
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
2
num At Risk
19
term
Face oedema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
2
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
24
num At Risk
476
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Malaise
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
4
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
23
num At Risk
476
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
8
group Id
EG008
num Affected
2
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
20
num At Risk
476
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
8
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
17
num At Risk
476
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Peripheral swelling
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
25
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
16
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Mucosal inflammation

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
14
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
19
term
Dyspnoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
8
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Pleural effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
6
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Pneumonitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
3
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
19
term
Pulmonary embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
3
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Chronic obstructive pulmonary disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
3
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Respiratory failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Haemoptysis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Hypoxia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Pneumothorax
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Pulmonary oedema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Acute respiratory failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
25
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
476
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
8
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
19
term
Bronchial obstruction

time Frame

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 2.5 years.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice