Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma

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 because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.

All randomized participants

→

secondary · POSTED

OS is defined as as the time between the date of randomization and the date of death.

All randomized Participants

→

secondary · POSTED

the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of adverse events

All treated participants

→

secondary · POSTED

The Safety and Tolerability of nivolumab and ipilimumab was measured by the incidence of serious adverse events

all treated participants

→

secondary · POSTED

the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of Deaths

All treated participants

→

secondary · POSTED

The Safety and Tolerability of Nivolumab and Ipilimumab measured by the incidence of Laboratory abnormalities.

Participants with a CTC graded Laboratory Result for the given parameter from both Baseline and On-treatment

→

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

EORTC QLQ · Health Related Quality of Life (HRQoL) Evaluation

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-melanoma-keytruda-qlex-b6745983
nct id: NCT02388906
qol key: qol-0007
source section id: NCT02388906-om-0007
source outcome index: 7
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Health Related Quality of Life (HRQoL) Evaluation
measure definition: HRQoL was measured by mean changes from baseline in EORTC-QLQ-C30 global health status/QoL composite scale and in remaining EORTC QLQ-C30 scales in all randomized participants. EORTC QLQ-C30 is the most commonly used QoL instrument in melanoma clinical studies, is a 30-item instrument that has gained wide acceptance in oncology clinical studies and comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Except for the overall health status and global quality of life items, responses for all items are 4 point categorical scales ranging from 1 (Not at all) to 4 (Very much). The overall health status/quality of life responses are 7-point Likert scales for which higher score reflects higher health status/quality of life for the 7-point Likert scale.
time frame: up to 36 months
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: All randomized Participants with values from the second follow-up visit
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-melanoma-keytruda-qlex-b6745983
nct id: NCT02388906
trial label: Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma
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: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 2
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0000
source section id
NCT02388906-om-0000
source outcome index
0
endpoint
Recurrence-free Survival (RFS)
endpoint definition
RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.
time origin
up to 36 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants
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-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0001
source section id
NCT02388906-om-0001
source outcome index
1
endpoint
Overall Survival (OS)
endpoint definition
OS is defined as as the time between the date of randomization and the date of death.
time origin
up to 106.6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized Participants
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-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0002
source section id
NCT02388906-om-0002
source outcome index
2
endpoint
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Adverse Events
endpoint definition
the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of adverse events
time origin
reported between first dose and 30 days after last dose of study therapy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All treated participants
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-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0003
source section id
NCT02388906-om-0003
source outcome index
3
endpoint
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events
endpoint definition
The Safety and Tolerability of nivolumab and ipilimumab was measured by the incidence of serious adverse events
time origin
reported between the first dose and 30 days after last dose of study therapy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
all treated participants
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-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0004
source section id
NCT02388906-om-0004
source outcome index
4
endpoint
the Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Deaths
endpoint definition
the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of Deaths
time origin
reported between first dose and 30 to 100 days after last dose of study therapy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All treated participants
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-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0005
source section id
NCT02388906-om-0005
source outcome index
5
endpoint
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
endpoint definition
The Safety and Tolerability of Nivolumab and Ipilimumab measured by the incidence of Laboratory abnormalities.
time origin
reported after first dose and within 30 days of last dose of the study therapy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants with a CTC graded Laboratory Result for the given parameter from both Baseline and On-treatment
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-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0000
arm key
OG000
arm label
Nivolumab 3 mg/kg
regimen
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
analyzed count
453
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02388906-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0000
arm key
OG001
arm label
Ipilimumab 10 mg/kg
regimen
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
analyzed count
453
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02388906-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0001
arm key
OG000
arm label
Nivolumab 3 mg/kg
regimen
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
analyzed count
453
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02388906-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0001
arm key
OG001
arm label
Ipilimumab 10 mg/kg
regimen
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
analyzed count
453
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02388906-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0002
arm key
OG000
arm label
Nivolumab 3 mg/kg
regimen
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
analyzed count
452
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02388906-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0002
arm key
OG001
arm label
Ipilimumab 10 mg/kg
regimen
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
analyzed count
453
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02388906-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0003
arm key
OG000
arm label
Nivolumab 3 mg/kg
regimen
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
analyzed count
452
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02388906-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0003
arm key
OG001
arm label
Ipilimumab 10 mg/kg
regimen
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
analyzed count
453
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02388906-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0004
arm key
OG000
arm label
Nivolumab 3 mg/kg
regimen
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
analyzed count
452
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02388906-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0004
arm key
OG001
arm label
Ipilimumab 10 mg/kg
regimen
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
analyzed count
453
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02388906-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0005
arm key
OG000
arm label
Nivolumab 3 mg/kg
regimen
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
analyzed count
452
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02388906-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
outcome key
om-0005
arm key
OG001
arm label
Ipilimumab 10 mg/kg
regimen
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
analyzed count
453
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02388906-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
harm key
EG000
source section id
NCT02388906-ae
event group key
EG000
event group label
Nivolumab 3 mg/kg
serious affected
106
serious at risk
452
other affected
421
other at risk
452
frequency threshold
5
collection period
Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
event definition
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
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-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
harm key
EG001
source section id
NCT02388906-ae
event group key
EG001
event group label
Ipilimumab 10 mg/kg
serious affected
215
serious at risk
453
other affected
438
other at risk
453
frequency threshold
5
collection period
Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
event definition
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
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

release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT02388906
qol key
qol-0007
source section id
NCT02388906-om-0007
source outcome index
7
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Health Related Quality of Life (HRQoL) Evaluation
measure definition
HRQoL was measured by mean changes from baseline in EORTC-QLQ-C30 global health status/QoL composite scale and in remaining EORTC QLQ-C30 scales in all randomized participants. EORTC QLQ-C30 is the most commonly used QoL instrument in melanoma clinical studies, is a 30-item instrument that has gained wide acceptance in oncology clinical studies and comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Except for the overall health status and global quality of life items, responses for all items are 4 point categorical scales ranging from 1 (Not at all) to 4 (Very much). The overall health status/quality of life responses are 7-point Likert scales for which higher score reflects higher health status/quality of life for the 7-point Likert scale.
time frame
up to 36 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All randomized Participants with values from the second follow-up visit
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice