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NCT03467516 · ClinicalTrials.gov registry record · Phase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma
A Phase 2 study of Melanoma, Uveal and Uveal Neoplasms, sponsored by Udai Kammula.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
- 1
- Study location
NCT03467516 is a Phase 2 study of Melanoma, Uveal and Uveal Neoplasms that is actively recruiting participants, run by Udai Kammula. The registered enrollment target is 47 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03467516, a Phase 2 study of Melanoma, Uveal and Uveal Neoplasms, is actively recruiting participants, sponsored by Udai Kammula.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 2 study in which the efficacy of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous TIL and high-dose aldesleukin in patients with metastatic uveal melanoma will be evaluated. Metastatic uveal melanoma (UM) carries a poor prognosis with estimated survival of 4-6 months. There are no known effective systemic therapies. Metastatic UM is classified as an "orphan" disease and there are currently few clinical trial options for these patients. Thus, novel systemic approaches are desperately needed. A recent pilot study has found that administration of autologous tumor infiltrating lymphocytes (TIL) generated from resected metastases can induce objective tumor response and durable complete response in metastatic uveal melanoma patients. These encouraging results require confirmation to determine if this immunotherapy is of future benefit in treating this disease.
Conditions Studied
Interventions
- BIOLOGICAL Tumor Infiltrating Lymphocytes (TIL)
Study Locations (1)
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2018-05-14 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03467516
The ClinicalTrials.gov registry entry for NCT03467516 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Udai Kammula, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Melanoma, Uveal appearing as the primary indexed condition, and to 1 intervention - of which Tumor Infiltrating Lymphocytes (TIL) is the first listed.
NCT03467516 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03467516 about?
NCT03467516 is a clinical study titled "Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma". This is a Phase 2 study in which the efficacy of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous TIL and high-dose aldesleukin in patients with metastatic uveal melanoma will be evaluated. Metastatic uveal melanoma (UM) carries a poor prognosis with estima...
What is the current status of trial NCT03467516?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2018-05-14. Estimated completion is 2027-12-31.
What conditions does trial NCT03467516 study?
This clinical trial studies the following conditions: Melanoma, Uveal, Uveal Neoplasms.
What interventions are being tested in trial NCT03467516?
The interventions under investigation include: Tumor Infiltrating Lymphocytes (TIL) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03467516?
This trial is sponsored by Udai Kammula, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03467516 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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