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NCT01810016 · ClinicalTrials.gov registry record · Phase 1
NY-ESO-1 Vaccine in Combination With Ipilimumab in Patients With Unresectable or Metastatic Melanoma
A Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01810016: Clinical Trial Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
NCT01810016 is a Phase 1 study that was terminated before completion, run by Ludwig Institute for Cancer Research. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01810016, a Phase 1 study, was terminated before completion, sponsored by Ludwig Institute for Cancer Research.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This was a Phase 1, open-label, non-randomized study of the combination of NY-ESO-1 plus ipilimumab in patients with unresectable or metastatic melanoma for whom treatment with ipilimumab was indicated. Patients must have had evidence of NY-ESO-1 or LAGE-1 tumor positivity and radiologically measurable disease by the immune-related Response Criteria (irRC). Primary study objectives were to determine the safety and tolerability of the combination and to evaluate humoral and cellular immune response. Secondary objectives were to evaluate tumor response and immunological changes in the tumor microenvironment.
Primary Outcome
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Dose-limiting toxicity (DLT) was defined as any ≥ Grade 3 hematologic or non-hematologic toxicity that was definitely, probably, or possibly related to the administration of the NY
Interventions
- BIOLOGICAL Ipilimumab
- BIOLOGICAL NY-ESO-1 Protein Vaccine
- BIOLOGICAL NY-ESO-1 OLP4 Vaccine with Poly-ICLC and Montanide
- BIOLOGICAL NY-ESO-1 OLP4 Vaccine with Poly-ICLC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2014-01-24 |
| Est. Completion | 2016-05-17 |
| Phase | Phase 1 |
Why NCT01810016 stopped before completion
NCT01810016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 4 interventions - of which Ipilimumab is the first listed.
NCT01810016 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01810016 about?
NCT01810016 is a clinical study titled "NY-ESO-1 Vaccine in Combination With Ipilimumab in Patients With Unresectable or Metastatic Melanoma". This was a Phase 1, open-label, non-randomized study of the combination of NY-ESO-1 plus ipilimumab in patients with unresectable or metastatic melanoma for whom treatment with ipilimumab was indicated. Patients must have had evidence of NY-ESO-1 or LAGE-1 tumor positivity and radiologically measura...
What is the current status of trial NCT01810016?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2014-01-24. Estimated completion is 2016-05-17.
What interventions are being tested in trial NCT01810016?
The interventions under investigation include: Ipilimumab (BIOLOGICAL), NY-ESO-1 Protein Vaccine (BIOLOGICAL), NY-ESO-1 OLP4 Vaccine with Poly-ICLC and Montanide (BIOLOGICAL), NY-ESO-1 OLP4 Vaccine with Poly-ICLC (BIOLOGICAL).
Who is sponsoring clinical trial NCT01810016?
This trial is sponsored by Ludwig Institute for Cancer Research, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01810016's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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