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Treatment combination of Durvalumab, Tremelimumab, Enfortumab Vedotin in patients with muscle invasive bladder cancer ineligible to cisplatin or Who Refuse Cisplatin
EU CTIS ID: 2023-507342-84-00
What this study is testing
Safety Run-In (SRI):To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin. Main Study: To compare the efficacy of durvalumab + tremelimumab + EV (Arm 1) relative to cystectomy (Arm 3) and durvalumab + EV (Arm 2) relative to cystectomy (Arm 3) on EFS
- 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
- Participants with histologically or cytologically documented muscle-invasive TCC (also known as UC) of the bladder.
- Participants with transitional cell and mixed transitional / non-transitional cell histologies
- Participants with MIBC clinical tumor (T) stage T2-T4aN0/1M0 or UC of the bladder with clinical stage T1N1M0 (participants with T1 stage are allowed only with N1 disease) according to the American Joint Committee on Cancer Staging Manual TCC of the bladder
- Participants should also have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC or bladder UC
- Medically fit for cystectomy and able to receive neoadjuvant therapy
- ECOG performance status of 0, 1, 2 at enrollment
You likely can't join if
- Evidence of lymph node (N2-3) or metastatic TCC/UC disease at the time of screening.
- Active infection
- Uncontrolled intercurrent illness
- Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies
- Current or prior use of immunosuppressive medication within 14 days before the first dose of IPs
See the full eligibility criteria
- Participants with histologically or cytologically documented muscle-invasive TCC (also known as UC) of the bladder.
- Participants with transitional cell and mixed transitional / non-transitional cell histologies
- Participants with MIBC clinical tumor (T) stage T2-T4aN0/1M0 or UC of the bladder with clinical stage T1N1M0 (participants with T1 stage are allowed only with N1 disease) according to the American Joint Committee on Cancer Staging Manual TCC of the bladder
- Participants should also have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC or bladder UC
- Medically fit for cystectomy and able to receive neoadjuvant therapy
- ECOG performance status of 0, 1, 2 at enrollment
- Availability of tumor sample prior to study entry
- Cisplatin-ineligible, as defined by any of the following criteria (based on Galsky et al 2011) or Refuse cisplatin based chemotherapy
- Must have a life expectancy of at least 12 weeks at randomization
- Evidence of lymph node (N2-3) or metastatic TCC/UC disease at the time of screening.
- Active infection
- Uncontrolled intercurrent illness
- Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies
- Current or prior use of immunosuppressive medication within 14 days before the first dose of IPs
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Turkey
- United Kingdom
- Serbia
- United States
- Chile
- Taiwan
- Canada
- Korea, Republic of
- Hong Kong
- Argentina
- Japan
- Israel
- Mexico
- Vietnam
- Thailand
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Turkey; United Kingdom; Serbia; United States; Chile and 10 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.