TriangleNCT01721772 · STUDY IN CONTEXT
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
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.
OS rate is calculated as the percentage of participants alive at the indicated timepoints
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.
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.
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.
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.
Reported safety
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-b5e1d696
- 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
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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-b5e1d696
- 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