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← Melanoma

NCT00769704 · STUDY IN CONTEXT

Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. 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

Durable response rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) maintained continuously for at least 6 months from the time the objective response was first observed and initiating within 12 months of starting therapy as assessed by the Endpoint Assessment Committee (EAC). This reflects all new sites of disease as well as disease sites identified at baseline. Disease assessments were performed at the beginning of each treatment cycle in accordance with modified World Health Organization criteria. CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline.

Intent-to-treat population (all participants randomized to receive study treatment), excluding one participant who was randomized three times.

→

secondary · POSTED

Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival time was censored at the last date the patient was known to be alive when the confirmation of death was absent or unknown. Participants were censored at the date of randomization if no additional follow-up data were obtained.

Intent-to-treat population

→

secondary · POSTED

Objective response rate was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) assessed by the Endpoint Assessment Committee (EAC). Best overall response for a patient is the best overall response observed across all time points. Disease assessments were performed at the beginning of each treatment cycle and assessed in accordance with modified World Health Organization criteria. CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline.

Intent-to-treat population

→

secondary · POSTED

The duration of response is defined as the longest individual period from entering response (CR or PR as assessed by the EAC) to the first documented evidence of the patient no longer meeting the criteria for being in response or death, whichever is earlier. Responses were censored at the last assessment showing response.

Participants with an objective response (CR or PR) per EAC assessment.

→

secondary · POSTED

Response onset is defined as the time from the date of randomization to the date of the first documented evidence of response (CR or PR) per EAC assessment.

Participants with an objective response (CR or PR) per EAC assessment.

→

secondary · POSTED

Time to treatment failure was assessed by the investigator, and calculated from randomization until the first clinically relevant disease progression where there is no response achieved after the progression, or until death if no such progression occurs. Participants who did not have clinically relevant progression or did not die were censored at the time of the their last tumor assessment. Participants who withdrew from treatment due to a clinically unacceptable toxicity were not considered as an event in the analysis. Progressive disease (PD) is defined as a ≥ 25% increase in the sum of the products of the perpendicular diameters of all measurable tumors since baseline, or the unequivocal appearance of a new tumor since the last response assessment time point. Clinically relevant progressive disease is PD that is associated with a decline in performance status and/or in the opinion of the investigator the patient requires alternative therapy.

Intent to treat population

→

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
nct id
NCT00769704
trial label
Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
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
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT00769704
    outcome key
    om-0000
    source section id
    NCT00769704-om-0000
    source outcome index
    0
    endpoint
    Durable Response Rate
    endpoint definition
    Durable response rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) maintained continuously for at least 6 months from the time the objective response was first observed and initiating within 12 months of starting therapy as assessed by the Endpoint Assessment Committee (EAC). This reflects all new sites of disease as well as disease sites identified at baseline. Disease assessments were performed at the beginning of each treatment cycle in accordance with modified World Health Organization criteria. CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline.
    time origin
    From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population (all participants randomized to receive study treatment), excluding one participant who was randomized three times.
    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
    nct id
    NCT00769704
    outcome key
    om-0001
    source section id
    NCT00769704-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. Overall survival time was censored at the last date the patient was known to be alive when the confirmation of death was absent or unknown. Participants were censored at the date of randomization if no additional follow-up data were obtained.
    time origin
    From randomization until the first 290 survival events had occurred (data cut-off date of 31 March 2014); median time on follow-up was 44 months.
    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
    nct id
    NCT00769704
    outcome key
    om-0002
    source section id
    NCT00769704-om-0002
    source outcome index
    2
    endpoint
    Objective Response Rate
    endpoint definition
    Objective response rate was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) assessed by the Endpoint Assessment Committee (EAC). Best overall response for a patient is the best overall response observed across all time points. Disease assessments were performed at the beginning of each treatment cycle and assessed in accordance with modified World Health Organization criteria. CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline.
    time origin
    From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT00769704
    outcome key
    om-0003
    source section id
    NCT00769704-om-0003
    source outcome index
    3
    endpoint
    Duration of Response
    endpoint definition
    The duration of response is defined as the longest individual period from entering response (CR or PR as assessed by the EAC) to the first documented evidence of the patient no longer meeting the criteria for being in response or death, whichever is earlier. Responses were censored at the last assessment showing response.
    time origin
    From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants with an objective response (CR or PR) per EAC assessment.
    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
    nct id
    NCT00769704
    outcome key
    om-0004
    source section id
    NCT00769704-om-0004
    source outcome index
    4
    endpoint
    Response Onset
    endpoint definition
    Response onset is defined as the time from the date of randomization to the date of the first documented evidence of response (CR or PR) per EAC assessment.
    time origin
    From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants with an objective response (CR or PR) per EAC assessment.
    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
    nct id
    NCT00769704
    outcome key
    om-0005
    source section id
    NCT00769704-om-0005
    source outcome index
    5
    endpoint
    Time to Treatment Failure
    endpoint definition
    Time to treatment failure was assessed by the investigator, and calculated from randomization until the first clinically relevant disease progression where there is no response achieved after the progression, or until death if no such progression occurs. Participants who did not have clinically relevant progression or did not die were censored at the time of the their last tumor assessment. Participants who withdrew from treatment due to a clinically unacceptable toxicity were not considered as an event in the analysis. Progressive disease (PD) is defined as a ≥ 25% increase in the sum of the products of the perpendicular diameters of all measurable tumors since baseline, or the unequivocal appearance of a new tumor since the last response assessment time point. Clinically relevant progressive disease is PD that is associated with a decline in performance status and/or in the opinion of the investigator the patient requires alternative therapy.
    time origin
    From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.
    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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT00769704
    outcome key
    om-0000
    arm key
    OG000
    arm label
    GM-CSF
    regimen
    GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
    analyzed count
    141
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00769704-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT00769704
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Talimogene Laherparepvec
    regimen
    Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
    analyzed count
    295
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00769704-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT00769704
    outcome key
    om-0001
    arm key
    OG000
    arm label
    GM-CSF
    regimen
    GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
    analyzed count
    141
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00769704-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT00769704
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Talimogene Laherparepvec
    regimen
    Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
    analyzed count
    295
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00769704-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT00769704
    outcome key
    om-0002
    arm key
    OG000
    arm label
    GM-CSF
    regimen
    GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
    analyzed count
    141
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00769704-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT00769704
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Talimogene Laherparepvec
    regimen
    Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
    analyzed count
    295
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00769704-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT00769704
    outcome key
    om-0003
    arm key
    OG000
    arm label
    GM-CSF
    regimen
    GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00769704-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT00769704
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Talimogene Laherparepvec
    regimen
    Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
    analyzed count
    78
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00769704-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT00769704
    outcome key
    om-0004
    arm key
    OG000
    arm label
    GM-CSF
    regimen
    GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00769704-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT00769704
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Talimogene Laherparepvec
    regimen
    Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
    analyzed count
    78
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00769704-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT00769704
    outcome key
    om-0005
    arm key
    OG000
    arm label
    GM-CSF
    regimen
    GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
    analyzed count
    141
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00769704-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT00769704
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Talimogene Laherparepvec
    regimen
    Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
    analyzed count
    295
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00769704-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT00769704
    harm key
    EG000
    source section id
    NCT00769704-ae
    event group key
    EG000
    event group label
    GM-CSF
    serious affected
    17
    serious at risk
    127
    other affected
    112
    other at risk
    127
    frequency threshold
    5
    collection period
    From first dose of study drug until 30 days after the last dose; Median duration of treatment was 10 weeks (range 0.6 to 72 weeks) in GM-CSF group and 23 weeks (range 0.1 to 78.9 weeks) in the talimogene laherparepvec group.
    event definition
    Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
    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
    nct id
    NCT00769704
    harm key
    EG001
    source section id
    NCT00769704-ae
    event group key
    EG001
    event group label
    Talimogene Laherparepvec
    serious affected
    75
    serious at risk
    292
    other affected
    282
    other at risk
    292
    frequency threshold
    5
    collection period
    From first dose of study drug until 30 days after the last dose; Median duration of treatment was 10 weeks (range 0.6 to 72 weeks) in GM-CSF group and 23 weeks (range 0.1 to 78.9 weeks) in the talimogene laherparepvec group.
    event definition
    Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
    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