Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic 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

OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive.

All randomized participants

→

primary · POSTED

OS rate is calculated as the percentage of participants alive at the indicated timepoints

All randomized participants

→

secondary · POSTED

Investigator-assessed PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Patients who died without progressing were considered to have progressed on the date of their death. Those who did not progress or die were documented on the date of their last evaluable tumor assessment. Patients who did not have any on-study tumor assessments and did not die were documented on their date of randomization. Those who started any subsequent anticancer therapy without a prior reported progression were documented on the date of their last evaluable tumor assessment prior to initiation of subsequent anticancer therapy.

All randomized participants

→

secondary · POSTED

The PFS rate at a time point is the estimated percentage of patients who have not progressed and are alive at that time point following randomization and is estimated using the Kaplan-Meier methodology.

All randomized participants

→

secondary · POSTED

ORR is defined as the percentage of participants with a best overall response of Response Evaluation Criteria in Solid Tumors (RECIST) defined complete response (CR) or partial response (PR). RECIST, volume 1.1 for target lesions: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, and the sum LD must have an absolute increase of ≥5 mm.

All randomized participants

→

secondary · POSTED

Overall Survival is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive. PD-L1 expression level is defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC (immunohistochemistry) assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression ≥5% (PD-L1 positive) versus patients with tumor PD-L1 expression \<5% (PD-L1 negative). Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization.

All randomized participants

→

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 · Change From Baseline in Health-related Quality of Life (HRQoL) Scores

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-melanoma-keytruda-qlex-b6745983
nct id: NCT01721772
qol key: qol-0006
source section id: NCT01721772-om-0006
source outcome index: 6
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Change From Baseline in Health-related Quality of Life (HRQoL) Scores
measure definition: HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL.
time frame: At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 months
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: Higher scores on global and functional scales indicate better
population note: All randomized participants with available measurements
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: NCT01721772
trial label: Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic 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
NCT01721772
outcome key
om-0000
source section id
NCT01721772-om-0000
source outcome index
0
endpoint
Overall Survival (OS)
endpoint definition
OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive.
time origin
From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 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
NCT01721772
outcome key
om-0005
source section id
NCT01721772-om-0005
source outcome index
5
endpoint
Overall Survival (OS) Rate
endpoint definition
OS rate is calculated as the percentage of participants alive at the indicated timepoints
time origin
From randomization to 6 months and or to 12 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
NCT01721772
outcome key
om-0001
source section id
NCT01721772-om-0001
source outcome index
1
endpoint
Progression-free Survival (PFS)
endpoint definition
Investigator-assessed PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Patients who died without progressing were considered to have progressed on the date of their death. Those who did not progress or die were documented on the date of their last evaluable tumor assessment. Patients who did not have any on-study tumor assessments and did not die were documented on their date of randomization. Those who started any subsequent anticancer therapy without a prior reported progression were documented on the date of their last evaluable tumor assessment prior to initiation of subsequent anticancer therapy.
time origin
From date of randomization up to date of disease progression or death, up to approximately 84 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
NCT01721772
outcome key
om-0002
source section id
NCT01721772-om-0002
source outcome index
2
endpoint
Progression-free Survival (PFS) Rate
endpoint definition
The PFS rate at a time point is the estimated percentage of patients who have not progressed and are alive at that time point following randomization and is estimated using the Kaplan-Meier methodology.
time origin
From randomization to the specified timepoints, up to 84 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
NCT01721772
outcome key
om-0003
source section id
NCT01721772-om-0003
source outcome index
3
endpoint
Objective Response Rate (ORR)
endpoint definition
ORR is defined as the percentage of participants with a best overall response of Response Evaluation Criteria in Solid Tumors (RECIST) defined complete response (CR) or partial response (PR). RECIST, volume 1.1 for target lesions: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, and the sum LD must have an absolute increase of ≥5 mm.
time origin
Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 94 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
NCT01721772
outcome key
om-0004
source section id
NCT01721772-om-0004
source outcome index
4
endpoint
Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level
endpoint definition
Overall Survival is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive. PD-L1 expression level is defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC (immunohistochemistry) assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression ≥5% (PD-L1 positive) versus patients with tumor PD-L1 expression \<5% (PD-L1 negative). Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization.
time origin
From date of randomization to date of disease progression or death, up to approximately 94 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

arms

release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01721772
outcome key
om-0000
arm key
OG000
arm label
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
regimen
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
analyzed count
210
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01721772-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01721772
outcome key
om-0000
arm key
OG001
arm label
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
regimen
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
analyzed count
208
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01721772-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01721772
outcome key
om-0001
arm key
OG000
arm label
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
regimen
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
analyzed count
210
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01721772-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01721772
outcome key
om-0001
arm key
OG001
arm label
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
regimen
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
analyzed count
208
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01721772-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01721772
outcome key
om-0002
arm key
OG000
arm label
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
regimen
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
analyzed count
210
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01721772-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01721772
outcome key
om-0002
arm key
OG001
arm label
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
regimen
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
analyzed count
208
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01721772-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01721772
outcome key
om-0003
arm key
OG000
arm label
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
regimen
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
analyzed count
210
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01721772-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01721772
outcome key
om-0003
arm key
OG001
arm label
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
regimen
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
analyzed count
208
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01721772-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01721772
outcome key
om-0004
arm key
OG000
arm label
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
regimen
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
analyzed count
210
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01721772-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01721772
outcome key
om-0004
arm key
OG001
arm label
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
regimen
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
analyzed count
208
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01721772-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01721772
outcome key
om-0005
arm key
OG000
arm label
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
regimen
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
analyzed count
210
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01721772-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01721772
outcome key
om-0005
arm key
OG001
arm label
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
regimen
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
analyzed count
208
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01721772-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01721772
harm key
EG000
source section id
NCT01721772-ae
event group key
EG000
event group label
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
serious affected
125
serious at risk
206
other affected
191
other at risk
206
frequency threshold
5
collection period
All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
event definition
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
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
NCT01721772
harm key
EG001
source section id
NCT01721772-ae
event group key
EG001
event group label
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
serious affected
119
serious at risk
205
other affected
187
other at risk
205
frequency threshold
5
collection period
All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
event definition
All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants
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
NCT01721772
qol key
qol-0006
source section id
NCT01721772-om-0006
source outcome index
6
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
measure definition
HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL.
time frame
At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 months
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
Higher scores on global and functional scales indicate better
population note
All randomized participants with available measurements
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