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← recurrent Vulvar Cancer

NCT03439085 · STUDY IN CONTEXT

DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated C

Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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 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

Will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Will be estimated with 95% confidence interval.

Two patients were not evaluable for response due to rapid clinical deterioration

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secondary · POSTED

Disease control rate is defined as N (%) patients with CR, PR, or SD by 24 weeks on study using RECIST version 1.1. For SD determination for DCR, the patient must have lack of progression for the first 24 weeks on study. Disease control rate will be assessed in the Response-evaluable and As-treated populations. Will be evaluated by RECIST version 1.1. Will be estimated with 95% confidence interval.

Source null

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secondary · POSTED

Progression Free Surival is defined as time in months from start of study treatment to first documentation of objective tumor progression as assessed by RECIST v1.1; Will be summarized using the method of Kaplan and Meier and Cox proportional hazards models.

Source null

→

secondary · POSTED

Will be summarized using the method of Kaplan and Meier and Cox proportional hazards models.

The cervical cancer cohort had 12 participants. The non cervical cohort had 9 participants.

→

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-vulvar-cancer-recurrent-a4d25099
nct id
NCT03439085
trial label
DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated C
applicability
unclear
applicability note
Attached because the study's own record describes recurrent 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
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
4
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer-recurrent-a4d25099
    nct id
    NCT03439085
    outcome key
    om-0000
    source section id
    NCT03439085-om-0000
    source outcome index
    0
    endpoint
    Overall Response Rate (ORR)
    endpoint definition
    Will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Will be estimated with 95% confidence interval.
    time origin
    Up to 2 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Two patients were not evaluable for response due to rapid clinical deterioration
    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-vulvar-cancer-recurrent-a4d25099
    nct id
    NCT03439085
    outcome key
    om-0001
    source section id
    NCT03439085-om-0001
    source outcome index
    1
    endpoint
    Disease Control Rate
    endpoint definition
    Disease control rate is defined as N (%) patients with CR, PR, or SD by 24 weeks on study using RECIST version 1.1. For SD determination for DCR, the patient must have lack of progression for the first 24 weeks on study. Disease control rate will be assessed in the Response-evaluable and As-treated populations. Will be evaluated by RECIST version 1.1. Will be estimated with 95% confidence interval.
    time origin
    Up to 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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-vulvar-cancer-recurrent-a4d25099
    nct id
    NCT03439085
    outcome key
    om-0002
    source section id
    NCT03439085-om-0002
    source outcome index
    2
    endpoint
    Median Progression Free Survival (PFS)
    endpoint definition
    Progression Free Surival is defined as time in months from start of study treatment to first documentation of objective tumor progression as assessed by RECIST v1.1; Will be summarized using the method of Kaplan and Meier and Cox proportional hazards models.
    time origin
    Up to 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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-vulvar-cancer-recurrent-a4d25099
    nct id
    NCT03439085
    outcome key
    om-0003
    source section id
    NCT03439085-om-0003
    source outcome index
    3
    endpoint
    Median Overall Survival
    endpoint definition
    Will be summarized using the method of Kaplan and Meier and Cox proportional hazards models.
    time origin
    Up to 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The cervical cancer cohort had 12 participants. The non cervical cohort had 9 participants.
    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-vulvar-cancer-recurrent-a4d25099
    nct id
    NCT03439085
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment Group
    regimen
    Patients received 7 mg of MEDI0457 intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks starting at week 4.
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03439085-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer-recurrent-a4d25099
    nct id
    NCT03439085
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment Group
    regimen
    Patients received 7 mg of MEDI0457 intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks starting at week 4.
    analyzed count
    21
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03439085-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer-recurrent-a4d25099
    nct id
    NCT03439085
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment Group
    regimen
    Patients received 7 mg of MEDI0457 intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks starting at week 4.
    analyzed count
    21
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03439085-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer-recurrent-a4d25099
    nct id
    NCT03439085
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment Group
    regimen
    Patients received 7 mg of MEDI0457 intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks starting at week 4.
    analyzed count
    21
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03439085-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer-recurrent-a4d25099
    nct id
    NCT03439085
    harm key
    EG000
    source section id
    NCT03439085-ae
    event group key
    EG000
    event group label
    Treatment Group
    serious affected
    1
    serious at risk
    21
    other affected
    21
    other at risk
    21
    frequency threshold
    1
    collection period
    From the first dose through 30 days after the last dose of study medication, up to 2 years
    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