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Trial · NCT03357757

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryEfficacy of Avelumab and VPA1 year after enrolment of last patient• Assessment of the clinical response rate according to the immune-related RECIST criteria (iRECIST)
PrimaryProportion of subjects who complete 4 doses of Avelumab in combination with VPA1 year after enrolment of last patient• Feasibility analysis, defined as the proportion of subjects who complete 4 doses of Avelumab in combination with VPA over the total duration of the study.
SecondaryOverall survival5 years from final study drug dosedefined as the time from the date of enrollment to the date of death, whatever the cause.
SecondaryProgression free survival5 years from final study drug doseProgression free survival is defined as the time between the date of treatment initiation and the date of disease progression or death (whatever the cause), whichever occurs first.
SecondaryNumber of participants with adverse eventsThrough study completion, up to 2 years• Incidence of adverse events (assessed as the incidence and severity of adverse events, including immune-related adverse events, and the number of discontinuations due to adverse events).
SecondaryIdentify specific virus-associated cancers as candidates for subsequent studyThrough study completion, up to 2 years
SecondaryMeasurement of Immuno-scoreThrough study completion, up to 2 yearsAffymetriX Micro-array (Immuno-score)
SecondaryMeasurement of MHC expressionThrough study completion, up to 2 years
SecondaryMeasurement of cell-free tumoral DNA in bloodThrough study completion, up to 2 years
SecondaryPhenotyping of Tumour Infiltrating LymphocytesThrough study completion, up to 2 years
SecondaryDNA viral loadThrough study completion, up to 2 yearsDNA Quantitative PCR (viral load)
SecondaryExpression of lytic viral genesThrough study completion, up to 2 years
SecondaryCytotoxic T-Lymphocyte immunophenotypingThrough study completion, up to 2 years
SecondaryT-cell receptor sequencingThrough study completion, up to 2 years
SecondaryHsp90 concentration in serumThrough study completion, up to 2 years

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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