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NCT03318900 · ClinicalTrials.gov registry record · Phase 1
T-Cell Infusion, Aldesleukin, and Utomilumab in Treating Patients With Recurrent Ovarian Cancer
A Phase 1 study of Recurrent Ovarian Carcinoma and HLA-A*0201 Positive Cells Present, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT03318900: Completed Phase 1 study of Recurrent Ovarian Carcinoma and HLA-A*0201 Positive Cells Present, sponsored by M.D. Anderson Cancer Center.
NCT03318900 is a Phase 1 study of Recurrent Ovarian Carcinoma and HLA-A*0201 Positive Cells Present that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 5 participants, below the 124-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03318900, a Phase 1 study of Recurrent Ovarian Carcinoma and HLA-A*0201 Positive Cells Present, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/Ib trial studies the side effects and best dose of utomilumab and how well it works with CD8-positive T-lymphocyte (T-cell infusion) and aldesleukin in treating patients with ovarian cancer that has come back. Aldesleukin may stimulate white blood cells to kill ovarian cancer cells. Giving white blood cells (T-cells) that have been activated by a vaccine with aldesleukin may kill more tumor cells. Immunotherapy with utomilumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving T-cell infusion with aldesleukin and utomilumab may work better in treating patients with ovarian cancer.
Primary Outcome
Due to lack of funding, the study was not able to accrue a sample size large enough to address the primary and secondary objectives
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Leukapheresis
- BIOLOGICAL Aldesleukin
- BIOLOGICAL Utomilumab
- DRUG CD8-Positive T-Lymphocyte
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-09-04 |
| Est. Completion | 2023-12-20 |
| Phase | Phase 1 |
What the finished NCT03318900 record still lists
NCT03318900 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 124-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (96% lower).
The record links to 4 conditions, with Recurrent Ovarian Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03318900 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03318900 about?
NCT03318900 is a clinical study titled "T-Cell Infusion, Aldesleukin, and Utomilumab in Treating Patients With Recurrent Ovarian Cancer". This phase I/Ib trial studies the side effects and best dose of utomilumab and how well it works with CD8-positive T-lymphocyte (T-cell infusion) and aldesleukin in treating patients with ovarian cancer that has come back. Aldesleukin may stimulate white blood cells to kill ovarian cancer cells. Giv...
What is the current status of trial NCT03318900?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2018-09-04. Estimated completion is 2023-12-20.
What conditions does trial NCT03318900 study?
This clinical trial studies the following conditions: Recurrent Ovarian Carcinoma, HLA-A*0201 Positive Cells Present, COL6A3 Positive, PRAME Positive.
What interventions are being tested in trial NCT03318900?
The interventions under investigation include: Cyclophosphamide (DRUG), Leukapheresis (PROCEDURE), Aldesleukin (BIOLOGICAL), Utomilumab (BIOLOGICAL), CD8-Positive T-Lymphocyte (DRUG).
Who is sponsoring clinical trial NCT03318900?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03318900 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Ovarian Carcinoma
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 NCT03318900's enrollment target sits among peer trials
5 39th of 39 the lowest of 39 other Recurrent Ovarian Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Ovarian Carcinoma 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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