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NCT04781088 · ClinicalTrials.gov registry record · Phase 2
Lenvatinib, Pembrolizumab, and Paclitaxel for Treatment of Recurrent Endometrial, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 2 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by Floor Backes, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 2
- Study locations
NCT04781088: Active Phase 2 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by Floor Backes, MD.
NCT04781088 is a Phase 2 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma that is active but no longer recruiting, run by Floor Backes, MD. The registered enrollment target is 38 participants, below the 123-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (69% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04781088, a Phase 2 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, is active but no longer recruiting, sponsored by Floor Backes, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II clinical trial studies the effect of lenvatinib, pembrolizumab, and paclitaxel in treating patients with endometrial, epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent). While all 3 study drugs are FDA approved, and 2-drug combinations have been studied, the 3- drug combination has not been studied yet. The investigators believe that the addition of pembrolizumab to weekly paclitaxel and lenvatinib (or weekly paclitaxel to pembrolizumab and lenvatinib) is highly effective and safe with manageable side effects in both recurrent endometrial and platinum resistant ovarian cancer. The purpose of this trial is to study how well lenvatinib, pembrolizumab, and weekly paclitaxel work together in women who have recurrent endometrial cancer and/or recurrent platinum resistant ovarian, fallopian tube, and primary peritoneal cancer, and what kind of side effects patients may experience.
Primary Outcome
Will be assessed by Response Evaluation Criteria in Solid Tumors 1.1. Will be reported as a percentage and will be calculated by the number of patients with a complete or partial response divided by the total number of patients. The percentage of patients with stable disease and progressive disease will be calculated in a similar fashion.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Paclitaxel
- DRUG Lenvatinib
Study Locations (2)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Pennsylvania
- Allegheny Health Network - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 2 |
What the registry record for NCT04781088 still lists
NCT04781088 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 123-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (69% lower).
The record links to 7 conditions, with Recurrent Ovarian Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04781088 reports a single indexed study location in Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04781088 about?
NCT04781088 is a clinical study titled "Lenvatinib, Pembrolizumab, and Paclitaxel for Treatment of Recurrent Endometrial, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". This phase II clinical trial studies the effect of lenvatinib, pembrolizumab, and paclitaxel in treating patients with endometrial, epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent). While all 3 study drugs are FDA approved, and 2-drug combinations have ...
What is the current status of trial NCT04781088?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2021-09-01. Estimated completion is 2026-08-31.
What conditions does trial NCT04781088 study?
This clinical trial studies the following conditions: Recurrent Ovarian Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Primary Peritoneal Carcinoma, Recurrent Endometrial Carcinoma, Platinum-Resistant Ovarian Carcinoma.
What interventions are being tested in trial NCT04781088?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Paclitaxel (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT04781088?
This trial is sponsored by Floor Backes, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04781088 being conducted?
This trial has 2 study locations across Ohio, Pennsylvania. 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 NCT04781088's enrollment target sits among peer trials
38 24th of 39 higher than 16 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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