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← Urothelial Carcinoma

NCT01353222 · STUDY IN CONTEXT

DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma

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 by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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 is defined as the time from randomization to death due to any cause. \*This study was terminated early due to administrative reasons.

Intent to Treat (ITT) population. \*This study was terminated early due to administrative reasons.

→

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-urothelial-carcinoma
nct id
NCT01353222
trial label
DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma
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
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
1
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma
    nct id
    NCT01353222
    outcome key
    om-0000
    source section id
    NCT01353222-om-0000
    source outcome index
    0
    endpoint
    Overall Survival
    endpoint definition
    Overall survival is defined as the time from randomization to death due to any cause. \*This study was terminated early due to administrative reasons.
    time origin
    Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 60 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent to Treat (ITT) population. \*This study was terminated early due to administrative reasons.
    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-urothelial-carcinoma
    nct id
    NCT01353222
    outcome key
    om-0000
    arm key
    OG000
    arm label
    DN24-02
    regimen
    DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
    analyzed count
    70
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01353222-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma
    nct id
    NCT01353222
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Standard of Care
    regimen
    Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population. Standard of Care: Standard of care
    analyzed count
    72
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01353222-om-0000#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma
    nct id
    NCT01353222
    harm key
    EG000
    source section id
    NCT01353222-ae
    event group key
    EG000
    event group label
    DN24-02
    serious affected
    20
    serious at risk
    67
    other affected
    64
    other at risk
    67
    frequency threshold
    5
    collection period
    Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later.
    event definition
    Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
    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-urothelial-carcinoma
    nct id
    NCT01353222
    harm key
    EG001
    source section id
    NCT01353222-ae
    event group key
    EG001
    event group label
    Standard of Care
    serious affected
    17
    serious at risk
    72
    other affected
    52
    other at risk
    72
    frequency threshold
    5
    collection period
    Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later.
    event definition
    Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
    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