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NCT01720836 · ClinicalTrials.gov registry record · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
A Phase 1 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Olivera Finn.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01720836: Recruiting Phase 1 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Olivera Finn.
NCT01720836 is a Phase 1 study of Non-small Cell Lung Cancer (NSCLC) that is actively recruiting participants, run by Olivera Finn. The registered enrollment target is 30 participants, below the 285-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01720836, a Phase 1 study of Non-small Cell Lung Cancer (NSCLC), is actively recruiting participants, sponsored by Olivera Finn.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
All subjects will receive the vaccine subcutaneously every 3 weeks x 3 with optional yearly booster vaccines up to and including 5 years post last vaccine for those patients who are confirmed responders to the vaccine . The rationale for using Poly-ICLC as an adjuvant are two ongoing trials at University of Pittsburgh Cancer Institute (UPCI) of the MUC1 100mer peptide vaccine - one as a therapeutic vaccine in subjects with metastatic castrate resistant prostate cancer and the other in subjects with advanced colonic adenomas at risk for developing colon cancer. The same formulation, MUC1 100mer peptide admixed with Poly-ICLC, is used in both trials. There has been no toxicity observed and the vaccine is highly immunogenic in early disease. In the proposed NSCLC trial the anti-MUC1 immune response will be thoroughly characterized.
Primary Outcome
Immunologic response will be measured by increases in anti MUC1 antibody titers post vaccination at different stages of disease: localized (Stage I, II) or locally advanced (Stage III) non-small cell lung cancer and neuroendocrine carcinoid tumors.
Conditions Studied
Interventions
- BIOLOGICAL Vaccine + PolyICLC
Study Locations (1)
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-11 |
| Est. Completion | 2032-10 |
| Phase | Phase 1 |
What NCT01720836 shows while recruiting
NCT01720836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 285-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 1 intervention - of which Vaccine + PolyICLC is the first listed.
NCT01720836 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01720836 about?
NCT01720836 is a clinical study titled "Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer". All subjects will receive the vaccine subcutaneously every 3 weeks x 3 with optional yearly booster vaccines up to and including 5 years post last vaccine for those patients who are confirmed responders to the vaccine . The rationale for using Poly-ICLC as an adjuvant are two ongoing trials at Unive...
What is the current status of trial NCT01720836?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2012-11. Estimated completion is 2032-10.
What conditions does trial NCT01720836 study?
This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC).
What interventions are being tested in trial NCT01720836?
The interventions under investigation include: Vaccine + PolyICLC (BIOLOGICAL).
Who is sponsoring clinical trial NCT01720836?
This trial is sponsored by Olivera Finn, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01720836 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01720836's enrollment target sits among peer trials
30 50th of 59 higher than 9 of 59 other Non-small Cell Lung Cancer (NSCLC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-small Cell Lung Cancer (NSCLC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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