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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 is a Phase 1 study that was terminated before completion, run by Ludwig Institute for Cancer Research. The registered enrollment target is 8 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01810016
The ClinicalTrials.gov registry entry for NCT01810016 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ludwig Institute for Cancer Research, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Ipilimumab is the first listed.
NCT01810016 reports 0 study locations.
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.
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