Trial · NCT00785122
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease control rate | after 27 weeks of vaccination | |
| Primary | Safety assessment | continuously | Safety assessment with special emphasis on the inclusion of the first 6 patients enrolled according to a pre-specified enrolment plan |
| Secondary | Tumour response rates and SD rate | after 27 and 37 weeks | |
| Secondary | DCR | after 37 weeks on study | |
| Secondary | Duration of response | till End of Study | |
| Secondary | Progression free survival | until tumor progression or death | |
| Secondary | Cellular immunomonitoring | till 27 weeks of vaccination or End Of Study | * T-cell responses to peptides contained in IMA910 * Description of T-cell responses * Percentage of multipeptide responders * Number of TUMAPs to which a response can be detected in multipeptide responders * Other immune cell populations that may influence T-cell responses such as regulatory T cells |
| Secondary | Biomarkers | Pre-Vaccination and End of Study | Pre-vaccination and post-vaccination analysis of serum markers with suspected influence on success of vaccination such as cytokines. |
| Secondary | Analysis of tumor tissue | optional if available | Depending on the amount, type \& quality parameters may be assessed: * Analysis of expression of tumor genes influencing immune response * Presentation of TUMAPs contained in IMA910 * Tumor infiltrating lymphocytes and other immune cell populations * Presence of molecules with suspected influence on immune response * Alteration in the tumor signature under the influence of study treatment with respect to expression of the target genes encoding the TUMAPs contained in IMA910 and all the above mentioned parameters |
| Secondary | Overall Safety | continuously till End of Study | |
| Secondary | Effect of imiquimod (2nd Cohort) on immune response | till End of Study | All effectiveness and immunological endpoints will be analysed separately for the 1st and the 2nd cohort. Overall safety, biomarkers and analysis of tumour tissue will be analysed separately for the 1st and the 2nd cohort and additionally overall for both cohorts. |
| Secondary | Overall survival | unitl death | |
| Secondary | Non-Cellular immunomonitoring | till 27 weeks of vaccination | * Serum levels of antibodies directed against peptides contained in IMA910 and against MHC/peptide complexes thereof * Presence of molecules with suspected influence on immune response such as serum TGFβ |
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.
For software
Read this list from software.
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