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← PROLEUKIN: metastatic Melanoma

NCT01721746 · STUDY IN CONTEXT

A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4

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

Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1

All randomized participants

→

primary · POSTED

Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. Unit of measure (months) is the median survival time.

All randomized participants

→

secondary · POSTED

Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.

All randomized participants

→

secondary · POSTED

Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants. PD-L1 expression evaluated for ORR.

All PD-L1 Evaluable Participants for ORR

→

secondary · POSTED

Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

All PD-L1 positive evaluable participants for OS

→

secondary · POSTED

Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

All PD-L1 negative evaluable participants for OS

→

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

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-proleukin-83ad18b5
nct id
NCT01721746
qol key
qol-0006
source section id
NCT01721746-om-0006
source outcome index
6
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
measure definition
Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric. Higher scores for all functional scales and Global Health Status=better HRQoL Increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL Decline from baseline for symptom scales =improvement in symptoms compared to baseline. A 10 point difference on a 100 point scale between treatments was considered clinically significant.
time frame
From Baseline (Day1) to second Follow-Up (Up to 96 months)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
Higher scores for all functional scales and Global Health Status=better
population note
All randomized participants
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-proleukin-83ad18b5
nct id
NCT01721746
trial label
A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4
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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0000
    source section id
    NCT01721746-om-0000
    source outcome index
    0
    endpoint
    Objective Response Rate (ORR)
    endpoint definition
    Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1
    time origin
    From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0001
    source section id
    NCT01721746-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS)
    endpoint definition
    Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. Unit of measure (months) is the median survival time.
    time origin
    Up to 96 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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0002
    source section id
    NCT01721746-om-0002
    source outcome index
    2
    endpoint
    Progression Free Survival (PFS)
    endpoint definition
    Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.
    time origin
    From the date of randomization to the date of the first documented progression or death (Up to approximately 38 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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0003
    source section id
    NCT01721746-om-0003
    source outcome index
    3
    endpoint
    Objective Response Rate (ORR) by Baseline PD-L1 Expression
    endpoint definition
    Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants. PD-L1 expression evaluated for ORR.
    time origin
    From date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All PD-L1 Evaluable Participants for ORR
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0004
    source section id
    NCT01721746-om-0004
    source outcome index
    4
    endpoint
    Overall Survival (OS) by PD-L1 Positive
    endpoint definition
    Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
    time origin
    Up to 96 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All PD-L1 positive evaluable participants for OS
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0005
    source section id
    NCT01721746-om-0005
    source outcome index
    5
    endpoint
    Overall Survival (OS) by PD-L1 Negative
    endpoint definition
    Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
    time origin
    Up to 96 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All PD-L1 negative evaluable participants for OS
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Nivolumab
    regimen
    Nivolumab 3 mg/kg IV over 60 minutes Q2W
    analyzed count
    272
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01721746-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
    regimen
    Dacarbazine: 1000 mg/m\^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W
    analyzed count
    133
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01721746-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Nivolumab
    regimen
    Nivolumab 3 mg/kg IV over 60 minutes Q2W
    analyzed count
    272
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01721746-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
    regimen
    Dacarbazine: 1000 mg/m\^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m\^2 IV Q3W
    analyzed count
    133
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01721746-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Nivolumab
    regimen
    Nivolumab 3 mg/kg IV over 60 minutes Q2W
    analyzed count
    272
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01721746-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
    regimen
    Dacarbazine: 1000 mg/m\^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m\^2 IV Q3W
    analyzed count
    133
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01721746-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Nivolumab
    regimen
    Nivolumab 3 mg/kg IV over 60 minutes Q2W
    analyzed count
    267
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01721746-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
    regimen
    Dacarbazine: 1000 mg/m\^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m\^2 IV Q3W
    analyzed count
    131
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01721746-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Nivolumab
    regimen
    Nivolumab 3 mg/kg IV over 60 minutes Q2W
    analyzed count
    135
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01721746-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
    regimen
    Dacarbazine: 1000 mg/m\^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m\^2 IV Q3W
    analyzed count
    67
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01721746-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Nivolumab
    regimen
    Nivolumab 3 mg/kg IV over 60 minutes Q2W
    analyzed count
    137
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01721746-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
    regimen
    Dacarbazine: 1000 mg/m\^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m\^2 IV Q3W
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01721746-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    harm key
    EG000
    source section id
    NCT01721746-ae
    event group key
    EG000
    event group label
    Nivolumab
    serious affected
    191
    serious at risk
    268
    other affected
    255
    other at risk
    268
    frequency threshold
    5
    collection period
    From first dose to 100 days post last dose (Up to 96 months)
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    harm key
    EG001
    source section id
    NCT01721746-ae
    event group key
    EG001
    event group label
    Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
    serious affected
    37
    serious at risk
    102
    other affected
    95
    other at risk
    102
    frequency threshold
    5
    collection period
    From first dose to 100 days post last dose (Up to 96 months)
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-proleukin-83ad18b5
    nct id
    NCT01721746
    qol key
    qol-0006
    source section id
    NCT01721746-om-0006
    source outcome index
    6
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Mean Change From Baseline in Health-related Quality of Life (HRQoL)
    measure definition
    Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric. Higher scores for all functional scales and Global Health Status=better HRQoL Increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL Decline from baseline for symptom scales =improvement in symptoms compared to baseline. A 10 point difference on a 100 point scale between treatments was considered clinically significant.
    time frame
    From Baseline (Day1) to second Follow-Up (Up to 96 months)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    Higher scores for all functional scales and Global Health Status=better
    population note
    All randomized participants
    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