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NCT04724018 · ClinicalTrials.gov registry record · Phase 1
Sacituzumab Govitecan Plus EV in Metastatic UC
A Phase 1 study of Bladder Cancer and Metastatic Urothelial Carcinoma, sponsored by Dana-Farber Cancer Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 106
- Enrollment target
- 1
- Study location
NCT04724018: Recruiting Phase 1 study of Bladder Cancer and Metastatic Urothelial Carcinoma, sponsored by Dana-Farber Cancer Institute.
NCT04724018 is a Phase 1 study of Bladder Cancer and Metastatic Urothelial Carcinoma that is actively recruiting participants, run by Dana-Farber Cancer Institute. The registered enrollment target is 106 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04724018, a Phase 1 study of Bladder Cancer and Metastatic Urothelial Carcinoma, is actively recruiting participants, sponsored by Dana-Farber Cancer Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 106 participants
- Enrollment target
- 1
- Study location
Study Summary
Phase I of this research study will assess what doses of Sacituzumab Govitecan and Enfortumab Vedotin can be safely combined in the treatment of metastatic urothelial carcinoma (mUC). In Phase II of the study, patients in one of the two cohorts will receive Sacituzumab Govitecan, Enfortumab Vedotin, and Pembrolizumab to assess the efficacy of this drug combination. The names of the study drugs in these investigational combinations are: * Enfortumab Vedotin * Sacituzumab Govitecan * Pembrolizumab
Primary Outcome
The Maximum Tolerated Dose (MTD) in mg of Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV) in Combination is assessed.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Sacituzumab Govitecan (SG)
- DRUG Enfortumab vedotin-ejfv (EV)
Study Locations (1)
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2021-05-20 |
| Est. Completion | 2028-05-01 |
| Phase | Phase 1 |
What NCT04724018 shows while recruiting
NCT04724018 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04724018 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04724018 about?
NCT04724018 is a clinical study titled "Sacituzumab Govitecan Plus EV in Metastatic UC". Phase I of this research study will assess what doses of Sacituzumab Govitecan and Enfortumab Vedotin can be safely combined in the treatment of metastatic urothelial carcinoma (mUC). In Phase II of the study, patients in one of the two cohorts will receive Sacituzumab Govitecan, Enfortumab Vedotin,...
What is the current status of trial NCT04724018?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2021-05-20. Estimated completion is 2028-05-01.
What conditions does trial NCT04724018 study?
This clinical trial studies the following conditions: Bladder Cancer, Metastatic Urothelial Carcinoma, Urothelial Cancer, Metastatic Urothelial Carcinoma of the Renal Pelvis and Ureter.
What interventions are being tested in trial NCT04724018?
The interventions under investigation include: Pembrolizumab (DRUG), Sacituzumab Govitecan (SG) (DRUG), Enfortumab vedotin-ejfv (EV) (DRUG).
Who is sponsoring clinical trial NCT04724018?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04724018 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04724018's enrollment target sits among peer trials
106 83rd of 175 higher than 93 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder 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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