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CheckMate 901: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 901
EU CTIS ID: 2022-501784-40-00
What this study is testing
Main Study: -To compare Overall Survival (OS) of nivolumab combined with ipilimumab versus standard of care (SOC) chemotherapy in cisplatin-ineligible participants with previously untreated, unresectable or metastatic urothelial carcinoma (UC). -To compare OS of nivolumab combined with ipilimumab versus standard of care (SOC) chemotherapy in PD-L1 positive (>= 1%) participants with previously untreated, unresectable or metastatic UC.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Metastatic or inoperable urothelial cancer
- Must have at least 1 lesion with measurable disease
- Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
- No prior systemic chemotherapy treatment in the metastatic setting
You likely can't join if
- Patients with ECOG PS >= 2
- Patients with disease that is suitable for local therapy administered with curative intent
- Patients with active brain metastases or leptomeningeal metastases
- Patients with active, known or suspected autoimmune disease
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Participants may not have received live/attenuated vaccines within 30 days prior to first study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- Taiwan
- Japan
- Korea, Republic of
- Australia
- Brazil
- Peru
- Switzerland
- China
- Argentina
- Chile
- South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; Taiwan; Japan; Korea, Republic of; Australia and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.