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← ALYMSYS: metastatic Renal cell carcinoma

NCT00738530 · STUDY IN CONTEXT

A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy

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

Percentage of Participants Who Died

ITT population included all participants randomized into the study.

→

primary · POSTED

Duration of survival was defined as the time between the date of randomization and date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. Kaplan-Meier estimates were used for analysis.

ITT population included all participants randomized into the study.

→

secondary · POSTED

Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.

ITT population included all participants randomized into the study.

→

secondary · POSTED

Progression-free survival was defined as the time between the date of randomization and the first date of documented progression or date of death due to any cause, whichever occurred first. Tumor assessment was performed using modified RECIST. Progressive disease was defined as at least a 20 percentage(%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event were censored at the date of last follow-up for progression or date of last available tumor measurement if no follow-up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.

ITT population included all participants randomized into the study.

→

secondary · POSTED

Time to progression was defined as the time between date of randomization and date of documented progression. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event (including participants who died before progressive disease) were censored at the date of last follow-up for progression or date of last available tumor measurement if no follow-up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.

ITT population included all participants randomized into the study.

→

secondary · POSTED

Treatment failure is defined as insufficient therapeutic response (including disease progression), death, withdrawal of treatment due to adverse events or laboratory abnormality, or withdrawal of informed consent. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.

ITT population included all participants randomized into the study.

→

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-renal-cell-cancer-alymsys-7a90c80d
nct id
NCT00738530
trial label
A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy
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
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0000
    source section id
    NCT00738530-om-0000
    source outcome index
    0
    endpoint
    Percentage of Participants Who Died
    endpoint definition
    Percentage of Participants Who Died
    time origin
    Baseline up to 4.25 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all participants randomized into the study.
    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-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0001
    source section id
    NCT00738530-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS) Duration
    endpoint definition
    Duration of survival was defined as the time between the date of randomization and date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. Kaplan-Meier estimates were used for analysis.
    time origin
    Baseline until death (up to 4.25 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all participants randomized into the study.
    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-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0002
    source section id
    NCT00738530-om-0002
    source outcome index
    2
    endpoint
    Percentage of Participants With Disease Progression or Death
    endpoint definition
    Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.
    time origin
    Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all participants randomized into the study.
    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-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0003
    source section id
    NCT00738530-om-0003
    source outcome index
    3
    endpoint
    Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
    endpoint definition
    Progression-free survival was defined as the time between the date of randomization and the first date of documented progression or date of death due to any cause, whichever occurred first. Tumor assessment was performed using modified RECIST. Progressive disease was defined as at least a 20 percentage(%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event were censored at the date of last follow-up for progression or date of last available tumor measurement if no follow-up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.
    time origin
    Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all participants randomized into the study.
    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-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0004
    source section id
    NCT00738530-om-0004
    source outcome index
    4
    endpoint
    Time to Progression (TTP) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
    endpoint definition
    Time to progression was defined as the time between date of randomization and date of documented progression. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event (including participants who died before progressive disease) were censored at the date of last follow-up for progression or date of last available tumor measurement if no follow-up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.
    time origin
    Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all participants randomized into the study.
    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-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0005
    source section id
    NCT00738530-om-0005
    source outcome index
    5
    endpoint
    Percentage of Participants With Treatment Failure
    endpoint definition
    Treatment failure is defined as insufficient therapeutic response (including disease progression), death, withdrawal of treatment due to adverse events or laboratory abnormality, or withdrawal of informed consent. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.
    time origin
    Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population included all participants randomized into the study.
    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-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Bevacizumab + IFN-Alfa-2A
    regimen
    Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    analyzed count
    327
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00738530-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo + IFN-Alfa-2A
    regimen
    Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    analyzed count
    322
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00738530-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Bevacizumab + IFN-Alfa-2A
    regimen
    Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    analyzed count
    327
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00738530-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo + IFN-Alfa-2A
    regimen
    Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    analyzed count
    322
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00738530-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Bevacizumab + IFN-Alfa-2A
    regimen
    Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    analyzed count
    327
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00738530-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo + IFN-Alfa-2A
    regimen
    Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    analyzed count
    322
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00738530-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Bevacizumab + IFN-Alfa-2A
    regimen
    Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    analyzed count
    327
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00738530-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo + IFN-Alfa-2A
    regimen
    Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    analyzed count
    322
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00738530-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Bevacizumab + IFN-Alfa-2A
    regimen
    Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    analyzed count
    327
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00738530-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo + IFN-Alfa-2A
    regimen
    Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    analyzed count
    322
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00738530-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Bevacizumab + IFN-Alfa-2A
    regimen
    Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    analyzed count
    327
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00738530-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo + IFN-Alfa-2A
    regimen
    Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
    analyzed count
    322
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00738530-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    harm key
    EG000
    source section id
    NCT00738530-ae
    event group key
    EG000
    event group label
    Bevacizumab + IFN-Alfa-2A
    serious affected
    103
    serious at risk
    337
    other affected
    319
    other at risk
    337
    frequency threshold
    5
    collection period
    Baseline up to 4.25 years
    event definition
    Safety population: all participants randomized and exposed to study drug (8 randomized participants did not receive study treatment and were not included, 2 in bevacizumab and 6 in placebo group). 12 participants randomized to placebo received bevacizumab, were included in bevacizumab arm. n=number of evaluable participants at specified time point.
    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-renal-cell-cancer-alymsys-7a90c80d
    nct id
    NCT00738530
    harm key
    EG001
    source section id
    NCT00738530-ae
    event group key
    EG001
    event group label
    Placebo + IFN-Alfa-2A
    serious affected
    51
    serious at risk
    304
    other affected
    279
    other at risk
    304
    frequency threshold
    5
    collection period
    Baseline up to 4.25 years
    event definition
    Safety population: all participants randomized and exposed to study drug (8 randomized participants did not receive study treatment and were not included, 2 in bevacizumab and 6 in placebo group). 12 participants randomized to placebo received bevacizumab, were included in bevacizumab arm. n=number of evaluable participants at specified time point.
    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