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NCT04630769 · ClinicalTrials.gov registry record · Phase 1
FT516 and IL2 With Enoblituzumab for Ovarian Cancer
A Phase 1 study of Ovarian Cancer and Primary Peritoneal Cavity Cancer, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
- 1
- Study location
NCT04630769: Completed Phase 1 study of Ovarian Cancer and Primary Peritoneal Cavity Cancer, sponsored by Masonic Cancer Center, University of Minnesota.
NCT04630769 is a Phase 1 study of Ovarian Cancer and Primary Peritoneal Cavity Cancer that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 3 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04630769, a Phase 1 study of Ovarian Cancer and Primary Peritoneal Cavity Cancer, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single center Phase I clinical trial of FT516 administered intraperitoneally (IP) once a week for 3 consecutive weeks for the treatment of recurrent gynecologic cancers. As this is an early 1st in human study and the 1st intraperitoneal infusion of FT516, the safety of FT516 is confirmed prior to adding enoblituzumab as an intravenous infusion approximately 1 week prior to the 1st dose of FT516 and every 3 weeks beginning on Day 22 (1 week after the last dose of FT516). Each dose of FT516 is followed directly by an IP infusion of interleukin-2 (IL-2) to facilitate natural killer (NK) cell survival. A short course of outpatient lymphodepletion chemotherapy is given prior to the 1st dose of FT516.
Primary Outcome
DLT is defined as any treatment emergent toxicity at least possibly related to the study treatment meeting one of the following criteria based on CTCAE v5 within 28 days (14 days for ascites) of the 1st FT516 infusion (for Cohort 4 and 5, DLT assessment starts with enoblituzumab and continues for 28 days after 1st FT516): Grade 3 organ toxicity (pulmonary, hepatic, renal, or neurologic) not pre-existing and lasting more than 72 hours , Any non-hematologic Grade 4 or 5 toxicity, Neutrophil count
Conditions Studied
Interventions
- DRUG Enoblituzumab
- DRUG IL-2
- DRUG IP FT516
Study Locations (1)
Minnesota
- University of Minnesota, Masonic Cancer Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-04-02 |
| Est. Completion | 2022-01-01 |
| Phase | Phase 1 |
What the finished NCT04630769 record still lists
NCT04630769 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 3 interventions - of which Enoblituzumab is the first listed.
NCT04630769 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT04630769 about?
NCT04630769 is a clinical study titled "FT516 and IL2 With Enoblituzumab for Ovarian Cancer". This is a single center Phase I clinical trial of FT516 administered intraperitoneally (IP) once a week for 3 consecutive weeks for the treatment of recurrent gynecologic cancers. As this is an early 1st in human study and the 1st intraperitoneal infusion of FT516, the safety of FT516 is confirmed p...
What is the current status of trial NCT04630769?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2021-04-02. Estimated completion is 2022-01-01.
What conditions does trial NCT04630769 study?
This clinical trial studies the following conditions: Ovarian Cancer, Primary Peritoneal Cavity Cancer, Fallopian Tube Adenocarcinoma.
What interventions are being tested in trial NCT04630769?
The interventions under investigation include: Enoblituzumab (DRUG), IL-2 (DRUG), IP FT516 (DRUG).
Who is sponsoring clinical trial NCT04630769?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04630769 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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