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
Public ClinicalTrials.gov record NCT03036098. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03036098
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,314 participants
Conditions and interventions
Conditions
Interventions
- Nivolumab Biological
- Ipilimumab Biological
- Gemcitabine Drug
- Cisplatin Drug
- Carboplatin Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 24, 2017 (Actual)
- Primary completion
- Aug 30, 2024 (Actual)
- Completion
- May 15, 2026 (Estimated)
- Last update posted
- Mar 6, 2026
2017 – 2026
United States locations
- U.S. sites
- 29
- U.S. states
- 19
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 0001 | Anchorage | Alaska | 99503 | — |
| Local Institution - 0115 | Fresno | California | 93703 | — |
| St Joseph Heritage Healthcare | Santa Rosa | California | 95403 | — |
| Local Institution - 0051 | Boca Raton | Florida | 33486 | — |
| Local Institution - 0087 | Fort Lauderdale | Florida | 33308 | — |
| Local Institution - 0062 | Jacksonville | Florida | 32256 | — |
| Local Institution - 0004 | Athens | Georgia | 30607 | — |
| Local Institution - 0033 | Thomasville | Georgia | 31792 | — |
| Local Institution - 0046 | Chicago | Illinois | 60612 | — |
| Local Institution - 0117 | New Orleans | Louisiana | 70121 | — |
| Local Institution - 0056 | Boston | Massachusetts | 02210 | — |
| Local Institution - 0073 | Boston | Massachusetts | 02215 | — |
| Local Institution - 0208 | Boston | Massachusetts | 02215 | — |
| Local Institution - 0207 | Milford | Massachusetts | 01757 | — |
| Local Institution - 0063 | Ann Arbor | Michigan | 48197 | — |
| Local Institution - 0002 | Burnsville | Minnesota | 55337 | — |
| Hattiesburg Clinic | Hattiesburg | Mississippi | 39401 | — |
| Local Institution - 0032 | Kansas City | Missouri | 64111-3220 | — |
| Local Institution - 0095 | St Louis | Missouri | 63110 | — |
| Local Institution - 0057 | Manchester | New Hampshire | 03103 | — |
| Local Institution - 0084 | Albuquerque | New Mexico | 87131 | — |
| Local Institution - 0083 | Buffalo | New York | 14263 | — |
| Local Institution - 0014 | Mineola | New York | 11501 | — |
| Local Institution - 0072 | New York | New York | 10029 | — |
| Local Institution - 0116 | Durham | North Carolina | 27710 | — |
| Local Institution - 0082 | Columbus | Ohio | 43210 | — |
| Local Institution - 0104 | Portland | Oregon | 97213 | — |
| Local Institution - 0013 | Pittsburgh | Pennsylvania | 15212 | — |
| Local Institution - 0086 | Kirkland | Washington | 98034 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 145 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03036098, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 6, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03036098 live on ClinicalTrials.gov.