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

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Part 1of the study was a dose-escalation phase that evaluated the safety and tolerability and defined the maximum tolerated dose or recommended Phase 2 dose of the NKTR-214/nivolumab doublet across 5 dosage/schedule levels. The results presented are for the DLT Population.

The DLT population included all Part 1 patients who took study treatment and followed up at least through the DLT evaluation period (q2w dosing: received ≥ 2 cycles of study treatment and stayed in study for at least 28 days; q3w dosing: received at least 1 cycle of study treatment and stayed in study for at least 21 days) or discontinued from study treatment due to DLT.

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primary · POSTED

Part 3 of the study was a schedule finding phase to establish the recommended phase 2 dosing schedules for Part 4 and assess the safety and tolerability for the NKTR-214/nivolumab/ipilimumab triplet combination. The results presented are for the DLT Population.

The DLT population included all Part 3 patients who received at least 1 cycle of study treatment and stayed in study for at least 21 days after first dose of ipilimumab or discontinued from study treatment due to DLT.

→

primary · POSTED

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) at Recommended Phase 2 Dose (RP2D). ORR is defined as the percentage of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). 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. ORR is calculated as the sum of CR and PR.

The response evaluable population included patients who had measurable disease (per RECIST 1.1) at baseline and also had at least 1 postbaseline assessment of tumor response prior to receiving new systemic anticancer therapy, surgical procedures or radiotherapy on target lesions.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-urothelial-carcinoma-opdivo-432072c9
nct id: NCT02983045
trial label: 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
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 3
harms Count: 10
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
outcome key
om-0000
source section id
NCT02983045-om-0000
source outcome index
0
endpoint
Part 1 Dose Escalation: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window
endpoint definition
Part 1of the study was a dose-escalation phase that evaluated the safety and tolerability and defined the maximum tolerated dose or recommended Phase 2 dose of the NKTR-214/nivolumab doublet across 5 dosage/schedule levels. The results presented are for the DLT Population.
time origin
Includes DLTs that occurred within the DLT window of at least 21 days after the first dose of study treatment (28 days for every 2 weeks dosing; 21 days for every 3 weeks dosing). Patients were counted only once under each preferred term.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The DLT population included all Part 1 patients who took study treatment and followed up at least through the DLT evaluation period (q2w dosing: received ≥ 2 cycles of study treatment and stayed in study for at least 28 days; q3w dosing: received at least 1 cycle of study treatment and stayed in study for at least 21 days) or discontinued from study treatment due to DLT.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
outcome key
om-0001
source section id
NCT02983045-om-0001
source outcome index
1
endpoint
Part 3 Schedule Finding: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window
endpoint definition
Part 3 of the study was a schedule finding phase to establish the recommended phase 2 dosing schedules for Part 4 and assess the safety and tolerability for the NKTR-214/nivolumab/ipilimumab triplet combination. The results presented are for the DLT Population.
time origin
Dose-limiting toxicities (DLTs) were assessed during a 3-week (21-day) DLT evaluation period beginning with the first dose of ipilimumab.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The DLT population included all Part 3 patients who received at least 1 cycle of study treatment and stayed in study for at least 21 days after first dose of ipilimumab or discontinued from study treatment due to DLT.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
outcome key
om-0002
source section id
NCT02983045-om-0002
source outcome index
2
endpoint
Part 2 and Part 4: Objective Response Rate (ORR) Per RECIST 1.1 at Recommended Phase 2 Dose (RP2D)
endpoint definition
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) at Recommended Phase 2 Dose (RP2D). ORR is defined as the percentage of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). 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. ORR is calculated as the sum of CR and PR.
time origin
Tumor assessment at Screening then every 8 weeks (± 7 days) from Cycle 1 Day 1 and end of treatment (unless scan done within 4 weeks) up to approximately 27 months.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The response evaluable population included patients who had measurable disease (per RECIST 1.1) at baseline and also had at least 1 postbaseline assessment of tumor response prior to receiving new systemic anticancer therapy, surgical procedures or radiotherapy on target lesions.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
outcome key
om-0000
arm key
OG000
arm label
Dose Escalation Cohort 1: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (240 mg) q2w
regimen
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.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02983045-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
outcome key
om-0000
arm key
OG001
arm label
Dose Escalation Cohort 2: NKTR-214 (0.006 mg/kg) q2w + Nivolumab (240 mg) q2w
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02983045-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
outcome key
om-0000
arm key
OG002
arm label
Dose Escalation Cohort 3: NKTR-214 (0.003 mg/kg) q2w + Nivolumab (240 mg) q2w
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02983045-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
outcome key
om-0000
arm key
OG003
arm label
Dose Escalation Cohort 4: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w
regimen
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.
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02983045-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
outcome key
om-0000
arm key
OG004
arm label
Dose Escalation Cohort 5: NKTR-214 (0.009 mg/kg) q3w + Nivolumab (360 mg) q3w
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02983045-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
outcome key
om-0001
arm key
OG000
arm label
Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab
regimen
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.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02983045-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
outcome key
om-0001
arm key
OG001
arm label
Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab
regimen
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.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02983045-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
outcome key
om-0001
arm key
OG002
arm label
Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab
regimen
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.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02983045-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
outcome key
om-0002
arm key
OG000
arm label
Part 2 Dose Expansion: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w
regimen
In this Part 2 of the study, the patients received a combination of NKTR-214 + nivolumab at the RP2D (NKTR 214 0.006 mg/kg q3w + nivolumab 360 mg q3w) with or without chemotherapy.
analyzed count
429
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02983045-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
outcome key
om-0002
arm key
OG001
arm label
Part 4 Dose Expansion of NKTR-214 + Nivolumab + Ipilimumab
regimen
Experimental Combination of NKTR-214 + nivolumab + ipilimumab Combination of NKTR-214 + nivolumab: Combination of NKTR-214 + nivolumab +ipilimumab administered at the RP2D dose/schedule.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02983045-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
harm key
EG000
source section id
NCT02983045-ae
event group key
EG000
event group label
Part 1 Dose Escalation Cohort 1: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (240 mg) q2w
serious affected
2
serious at risk
4
other affected
4
other at risk
4
frequency threshold
5
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
harm key
EG001
source section id
NCT02983045-ae
event group key
EG001
event group label
Part 1 Dose Escalation Cohort 2: NKTR-214 (0.006 mg/kg) q2w + Nivolumab (240 mg) q2w
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
harm key
EG002
source section id
NCT02983045-ae
event group key
EG002
event group label
Part 1 Dose Escalation Cohort 3: NKTR-214 (0.003 mg/kg) q2w + Nivolumab (240 mg) q2w
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
harm key
EG003
source section id
NCT02983045-ae
event group key
EG003
event group label
Part 1 Dose Escalation Cohort 4: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w
serious affected
9
serious at risk
25
other affected
25
other at risk
25
frequency threshold
5
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
harm key
EG004
source section id
NCT02983045-ae
event group key
EG004
event group label
Part 1 Dose Escalation Cohort 5: NKTR-214 (0.009 mg/kg) q3w + Nivolumab (360 mg) q3w
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
harm key
EG005
source section id
NCT02983045-ae
event group key
EG005
event group label
Part 2 Dose Expansion: NKTR-214 (0.006 mg/kg) q3w + Nivolumab (360 mg) q3w
serious affected
213
serious at risk
476
other affected
468
other at risk
476
frequency threshold
5
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
harm key
EG006
source section id
NCT02983045-ae
event group key
EG006
event group label
Part 3 Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab
serious affected
6
serious at risk
10
other affected
10
other at risk
10
frequency threshold
5
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
harm key
EG007
source section id
NCT02983045-ae
event group key
EG007
event group label
Part 3 Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab
serious affected
5
serious at risk
8
other affected
8
other at risk
8
frequency threshold
5
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
harm key
EG008
source section id
NCT02983045-ae
event group key
EG008
event group label
Part 3 Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab
serious affected
2
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02983045
harm key
EG009
source section id
NCT02983045-ae
event group key
EG009
event group label
Part 4 Dose Expansion of NKTR-214 + Nivolumab + Ipilimumab
serious affected
8
serious at risk
19
other affected
19
other at risk
19
frequency threshold
5
collection period
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.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice