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NCT04863885 · ClinicalTrials.gov registry record · Phase 1
Combination of Ipi/Nivo Plus Sacituzumab Govitecan in Metastatic Cisplatin Ineligible Urothelial Carcinoma Patients
A Phase 1 study of Metastatic Urothelial Carcinoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT04863885: Active Phase 1 study of Metastatic Urothelial Carcinoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT04863885 is a Phase 1 study of Metastatic Urothelial Carcinoma that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 46 participants, below the 129-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04863885, a Phase 1 study of Metastatic Urothelial Carcinoma, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to see how well the study drugs called Ipilimumab plus Nivolumab (IPI-NIVO) work when added to another study drug called Sacituzumab Govitecan for people who have metastatic bladder cancer.
Primary Outcome
Determine the Maximum Tolerated Dose (MTD)/ Recommended Phase 2 dose (RP2D) of Sacituzumab Govitecan when combined with Ipilimumab and Nivolumab
Conditions Studied
Interventions
- DRUG Sacituzumab govitecan
- DRUG Nivolumab
- DRUG Ipilimumab
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2021-04-30 |
| Est. Completion | 2027-10 |
| Phase | Phase 1 |
What the registry record for NCT04863885 still lists
NCT04863885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 129-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Sacituzumab govitecan is the first listed.
NCT04863885 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04863885 about?
NCT04863885 is a clinical study titled "Combination of Ipi/Nivo Plus Sacituzumab Govitecan in Metastatic Cisplatin Ineligible Urothelial Carcinoma Patients". The purpose of this study is to see how well the study drugs called Ipilimumab plus Nivolumab (IPI-NIVO) work when added to another study drug called Sacituzumab Govitecan for people who have metastatic bladder cancer.
What is the current status of trial NCT04863885?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2021-04-30. Estimated completion is 2027-10.
What conditions does trial NCT04863885 study?
This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma.
What interventions are being tested in trial NCT04863885?
The interventions under investigation include: Sacituzumab govitecan (DRUG), Nivolumab (DRUG), Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT04863885?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04863885 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Urothelial 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 NCT04863885's enrollment target sits among peer trials
46 17th of 30 higher than 14 of 30 other Metastatic Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Urothelial 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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