Trial · NCT03879694
Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors
NCT03879694, Phase 1, Completed, Roswell Park Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors. Trials, record NCT03879694. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03879694
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors
- NCT number
- NCT03879694
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 19 participants, actual
- Lead sponsor
- Roswell Park Cancer Institute
- Conditions
- Lung Atypical Carcinoid Tumor, Lung Typical Carcinoid Tumor, Metastatic Pancreatic Neuroendocrine Tumor
- Interventions
- Incomplete Freund's Adjuvant, Octreotide Acetate, Sargramostim, SVN53-67/M57-KLH Peptide Vaccine
- First posted
- 2019-03-19
- Last updated
- 2026-02-06
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016056 | Roswell Park Cancer Center Support Grant | JOHNSON, CANDACE S | ROSWELL PARK CANCER INSTITUTE CORP | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03879694
GET https://conductscience.org/api/trials/v1/NCT03879694/registered