Trial · NCT03879694
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events of SVN53-67/M57-KLH peptide vaccine in combination with octreotide acetate in patients with neuroendocrine tumors | Up to 15 months | Will be assessed with National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will consider a toxicity to be an adverse event that is possibly, probably or definitely related to treatment. The maximum grade of toxicity for each category of interest will be recorded for each patient and the summary results will be tabulated by category and grade. Will be quantified using the observed rates of the adverse events, serious adverse events (SAE) and regimen limiting toxicities. Toxicity rates will be described using upper 1-sided 95% Jeffreys binomial confidence intervals. |
| Secondary | Immunogenicity of SVN53-67/M57-KLH peptide vaccine | Baseline up to 15 months | Survivin-specific CD8+ responses will be measured individually at baseline, 12 weeks and end of-study. These measures will be summarized by descriptive statistics (means, medians, quartiles, etc.). Confidence intervals will be constructed for the median and the mean. Exploratory graphical analysis will be used to discover associations among variables. |
| Secondary | Immunogenicity of SVN53-67/M57-KLH peptide vaccine | Baseline up to 15 months | Anti-survivin antibody (humoral) responses will be measured individually at baseline, 12 weeks and end of-study. These measures will be summarized by descriptive statistics (means, medians, quartiles, etc.). Confidence intervals will be constructed for the median and the mean. Exploratory graphical analysis will be used to discover associations among variables. |
| Secondary | Rate of progression | Up to 15 months | Will be based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 on computed tomography scan and comparison rate prior to start of treatment. |
| Secondary | Clinical benefit | Up to 12 months | Will be assessed with RECIST v1.1. Clinical Benefit (CB) is defined as number of patients having best overall response as complete response (CR), partial response (PR) or stable disease (SD). The estimated distribution of CB will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. |
| Secondary | Time to progression (TTP) | From enrollment to first documented progression per RECISTv1.1, assessed up to 15 months | The TTP of each patient will be compared to TTP prior to study entry. The analysis will be descriptive and reported separately for each patient. |
| Secondary | Overall response rate (ORR) | Up to 15 months | Measured by RECIST v1.1. |
| Secondary | Duration of response (DOR) | Up to 15 months | Measured by RECIST v1.1. |
| Other | Serum levels of chromogranin A, serotonin and 5-HIAA | Baseline up to 15 months | Exploratory graphical analysis will be used to discover associations among variables. |
| Other | Serum levels of serotonin and 5-HIAA | Baseline up to 15 months | Exploratory graphical analysis will be used to discover associations among variables |
| Other | Serum levels of 5-HIAA | Baseline up to 15 months | Exploratory graphical analysis will be used to discover associations among variables |
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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