BridgeMD
A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.
EU CTIS ID: 2022-501970-20-01
What this study is testing
To compare event-free survival (EFS) between Arm A (perioperative pembrolizumab + neoadjuvant chemotherapy + Radical Cystectomy [RC] + Pelvic Lymph Node Dissection [PLND]) and Arm B (perioperative placebo + neoadjuvant chemotherapy + RC + PLND).
- 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
- Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology.
- Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI)) of the chest/abdomen/pelvis.
- Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND).
- Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Have adequate organ function.
- Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
You likely can't join if
- Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions.
- Has had an allogenic tissue/solid organ transplant.
- Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).
- Has ≥N2 disease or metastatic disease (M1) as identified by imaging.
- Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol.
- Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder.
See the full eligibility criteria
- Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology.
- Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI)) of the chest/abdomen/pelvis.
- Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND).
- Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Have adequate organ function.
- Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
- Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions.
- Has had an allogenic tissue/solid organ transplant.
- Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).
- Has ≥N2 disease or metastatic disease (M1) as identified by imaging.
- Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol.
- Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder.
- Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC.
- Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention.
- Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection, Hepatitis B infection or known active Hepatitis C infection.
- Has a known psychiatric or substance abuse disorder.
The study team makes the final eligibility decision.
Where it's taking place
- Ukraine
- United Kingdom
- Australia
- United States
- Israel
- Korea, Republic of
- Japan
- Turkey
- Canada
- Russian Federation
- Mexico
- 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 Ukraine; United Kingdom; Australia; United States; Israel; Korea, Republic of and 6 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.