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← KEYTRUDA QLEX: unresectable metastatic Melanoma

NCT00091572 · STUDY IN CONTEXT

Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)

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

Overall Survival was defined as the time from the date of randomization to the date of death from any cause.

Intent to Treat Population

→

secondary · POSTED

Progression free survival was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause.

Intent to Treat Population

→

secondary · POSTED

Based on investigator's assessment of response in subjects with measurable lesions. Objective response = complete response + partial response. Complete response = disappearance of all target lesions. Partial response = at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter.

Intent to treat population with measurable disease at Baseline.

→

secondary · POSTED

Duration of objective response was measured from the time the criteria were met for complete response or partial response to the first date that recurrent or progressive disease was objectively documented.

All responders

→

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-melanoma-keytruda-qlex-b6745983
nct id
NCT00091572
trial label
Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)
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
4
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00091572
    outcome key
    om-0001
    source section id
    NCT00091572-om-0001
    source outcome index
    1
    endpoint
    Overall Survival
    endpoint definition
    Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
    time origin
    The final analysis was to be performed when at least 616 deaths had occurred.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent to Treat Population
    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-keytruda-qlex-b6745983
    nct id
    NCT00091572
    outcome key
    om-0000
    source section id
    NCT00091572-om-0000
    source outcome index
    0
    endpoint
    Progression Free Survival
    endpoint definition
    Progression free survival was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause.
    time origin
    Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent to Treat Population
    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-keytruda-qlex-b6745983
    nct id
    NCT00091572
    outcome key
    om-0002
    source section id
    NCT00091572-om-0002
    source outcome index
    2
    endpoint
    Objective Response Rate in Subjects With Measurable Lesions
    endpoint definition
    Based on investigator's assessment of response in subjects with measurable lesions. Objective response = complete response + partial response. Complete response = disappearance of all target lesions. Partial response = at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter.
    time origin
    Treatment continued until disease progression or unacceptable toxicity.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent to treat population with measurable disease at Baseline.
    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-keytruda-qlex-b6745983
    nct id
    NCT00091572
    outcome key
    om-0003
    source section id
    NCT00091572-om-0003
    source outcome index
    3
    endpoint
    Duration of Objective Response
    endpoint definition
    Duration of objective response was measured from the time the criteria were met for complete response or partial response to the first date that recurrent or progressive disease was objectively documented.
    time origin
    Treatment continued until disease progression or unacceptable toxicity.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All responders
    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-keytruda-qlex-b6745983
    nct id
    NCT00091572
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Temozolomide
    regimen
    temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
    analyzed count
    429
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00091572-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00091572
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Dacarbazine
    regimen
    dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
    analyzed count
    430
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00091572-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00091572
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Temozolomide
    regimen
    temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
    analyzed count
    429
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00091572-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00091572
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Dacarbazine
    regimen
    dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
    analyzed count
    430
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00091572-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00091572
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Temozolomide
    regimen
    temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
    analyzed count
    401
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00091572-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00091572
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Dacarbazine
    regimen
    dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
    analyzed count
    388
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00091572-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00091572
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Temozolomide
    regimen
    temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
    analyzed count
    55
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00091572-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00091572
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Dacarbazine
    regimen
    dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
    analyzed count
    37
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00091572-om-0003#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00091572
    harm key
    EG000
    source section id
    NCT00091572-ae
    event group key
    EG000
    event group label
    Temozolomide
    serious affected
    124
    serious at risk
    419
    other affected
    394
    other at risk
    419
    frequency threshold
    5
    collection period
    Source null
    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-keytruda-qlex-b6745983
    nct id
    NCT00091572
    harm key
    EG001
    source section id
    NCT00091572-ae
    event group key
    EG001
    event group label
    Dacarbazine
    serious affected
    100
    serious at risk
    421
    other affected
    374
    other at risk
    421
    frequency threshold
    5
    collection period
    Source null
    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