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NCT03036098 · ClinicalTrials.gov registry record · Phase 3
Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer
A Phase 3 study of Urothelial Cancer, sponsored by Bristol-Myers Squibb.
- Active
- Registry status
- Phase 3
- Development phase
- 1,314
- Enrollment target
- 20
- Study locations
NCT03036098: Active Phase 3 study of Urothelial Cancer, sponsored by Bristol-Myers Squibb.
NCT03036098 is a Phase 3 study of Urothelial Cancer that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 1,314 participants, above the 522-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (152% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03036098, a Phase 3 study of Urothelial Cancer, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,314 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.
Primary Outcome
This measure looks at how long participants who cannot receive cisplatin (a type of chemotherapy) live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no f
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Gemcitabine
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
Study Locations (20)
Massachusetts
- Local Institution - 0056 - Boston
- Local Institution - 0073 - Boston
- Local Institution - 0208 - Boston
- Local Institution - 0207 - Milford
Florida
- Local Institution - 0051 - Boca Raton
- Local Institution - 0087 - Fort Lauderdale
- Local Institution - 0062 - Jacksonville
California
- Local Institution - 0115 - Fresno
- St Joseph Heritage Healthcare - Santa Rosa
Georgia
- Local Institution - 0004 - Athens
- Local Institution - 0033 - Thomasville
Missouri
- Local Institution - 0032 - Kansas City
- Local Institution - 0095 - St Louis
Alaska
- Local Institution - 0001 - Anchorage
Illinois
- Local Institution - 0046 - Chicago
Louisiana
- Local Institution - 0117 - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,314 participants |
| Start Date | 2017-03-24 |
| Est. Completion | 2026-05-15 |
| Phase | Phase 3 |
What the registry record for NCT03036098 still lists
NCT03036098 is an interventional study that assigns participants to a tested intervention. Its 1,314 participants enrollment target places it among the larger protocols in the corpus, above the 522-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (152% higher).
The record links to 1 condition, with Urothelial Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT03036098 names 20 study sites across 12 states, led by Massachusetts, Florida, California.
Frequently Asked Questions
What is clinical trial NCT03036098 about?
NCT03036098 is a clinical study titled "Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer". The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or...
What is the current status of trial NCT03036098?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,314 participants. The study started on 2017-03-24. Estimated completion is 2026-05-15.
What conditions does trial NCT03036098 study?
This clinical trial studies the following conditions: Urothelial Cancer.
What interventions are being tested in trial NCT03036098?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Gemcitabine (DRUG), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03036098?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03036098 being conducted?
This trial has 20 study locations across Alaska, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03036098's enrollment target sits among peer trials
1,314 2nd of 25 the highest of 25 other Urothelial Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial 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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