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NCT03245892 · ClinicalTrials.gov registry record · Phase 1
A Study of Carboplatin and Paclitaxel Chemotherapy With Nivolumab With or Without Ipilimumab in Patients With Ovarian Cancer
A Phase 1 study of Primary Peritoneal Cancer and Fallopian Tube, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT03245892: Completed Phase 1 study of Primary Peritoneal Cancer and Fallopian Tube, sponsored by Memorial Sloan Kettering Cancer Center.
NCT03245892 is a Phase 1 study of Primary Peritoneal Cancer and Fallopian Tube that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 27 participants, below the 151-participant average among 27 other Primary Peritoneal Cancer trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03245892, a Phase 1 study of Primary Peritoneal Cancer and Fallopian Tube, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to find out what effects, good or bad, the addition of nivolumab or the combination of nivolumab plus ipilimumab to typical chemotherapy has on the treatment of advanced high-grade serous cancers of ovarian, fallopian tube, or primary peritoneal origin. The typical chemotherapy treatment is Carboplatin and Paclitaxel.
Primary Outcome
The safety of this regimen will be assessed by determination of the DLTs observed in the study population. If \>=3/10 DLTs are seen we will deem the regimen not safe and stop the trial early. If \>=5/20 patients have DLTs the treatment regimen would be deemed unsafe. Enrollment will be halted after 10 patients have accrued until all 10 patients have cleared the DLT period of 6 weeks
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- PROCEDURE Cytoreductive surgery
- DRUG Carboplatin and Paclitaxel
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2017-08-04 |
| Est. Completion | 2025-12-04 |
| Phase | Phase 1 |
What the finished NCT03245892 record still lists
NCT03245892 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 151-participant average among 27 other Primary Peritoneal Cancer trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Primary Peritoneal Cancer appearing as the primary indexed condition, and to 4 interventions - of which Nivolumab is the first listed.
NCT03245892 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03245892 about?
NCT03245892 is a clinical study titled "A Study of Carboplatin and Paclitaxel Chemotherapy With Nivolumab With or Without Ipilimumab in Patients With Ovarian Cancer". The purpose of this study is to find out what effects, good or bad, the addition of nivolumab or the combination of nivolumab plus ipilimumab to typical chemotherapy has on the treatment of advanced high-grade serous cancers of ovarian, fallopian tube, or primary peritoneal origin. The typical chemo...
What is the current status of trial NCT03245892?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2017-08-04. Estimated completion is 2025-12-04.
What conditions does trial NCT03245892 study?
This clinical trial studies the following conditions: Primary Peritoneal Cancer, Fallopian Tube, High Grade Serous Ovarian.
What interventions are being tested in trial NCT03245892?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Cytoreductive surgery (PROCEDURE), Carboplatin and Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT03245892?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03245892 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03245892's enrollment target sits among peer trials
27 21st of 27 higher than 7 of 27 other Primary Peritoneal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Peritoneal Cancer 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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