Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
Launched by MERCK SHARP & DOHME LLC · Jan 5, 2021
Trial Information
Current as of June 20, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new combination treatment for people with muscle invasive bladder cancer (MIBC) who can receive cisplatin, a common chemotherapy drug. The study compares the effects of two treatments: one group will receive a combination of enfortumab vedotin (EV) and pembrolizumab along with surgery to remove the bladder and nearby lymph nodes, while the other group will receive the standard chemotherapy treatment (gemcitabine and cisplatin) followed by the same surgery. The goal is to see if the new treatment helps patients live longer without cancer returning compared to the standard approach.
To be eligible for this trial, participants must have a confirmed diagnosis of muscle invasive bladder cancer that has not spread to other parts of the body. They should also be healthy enough to undergo major surgery and have good organ function. Additionally, certain health conditions and prior treatments may prevent someone from joining the trial, such as having received other cancer treatments in the past or having specific health issues. If you decide to participate, you will receive regular check-ups and monitoring throughout the study to ensure your safety and track how well the treatment is working.
Gender
ALL
Eligibility criteria
- Inclusion 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.
- Exclusion Criteria:
- • Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions
- • 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
- • Has had an allogenic tissue/solid organ transplant
- • Has ongoing sensory or motor neuropathy Grade 2 or higher
- • Has active keratitis (superficial punctate keratitis) or corneal ulcerations
- • Has a history of uncontrolled diabetes defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7% to \<8% with associated diabetes symptoms
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Dallas, Texas, United States
Los Angeles, California, United States
Debrecen, , Hungary
Taipei, , Taiwan
Phoenix, Arizona, United States
Fullerton, California, United States
Stanford, California, United States
Aurora, Colorado, United States
Gainesville, Florida, United States
Iowa City, Iowa, United States
Louisville, Kentucky, United States
New York, New York, United States
White Plains, New York, United States
Durham, North Carolina, United States
Winston Salem, North Carolina, United States
Portland, Oregon, United States
Bala Cynwyd, Pennsylvania, United States
Greenville, South Carolina, United States
Knoxville, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Madison, Wisconsin, United States
South Brisbane, Queensland, Australia
Elizabeth Vale, South Australia, Australia
Vancouver, British Columbia, Canada
Moncton, New Brunswick, Canada
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Nantong, Jiangsu, China
Shanghai, Shanghai, China
Brno, Jihomoravsky Kraj, Czechia
Hradec Kralove, , Czechia
Olomouc, , Czechia
Praha 4, , Czechia
Marseille, Bouches Du Rhone, France
Besancon, Doubs, France
Brest, Finistere, France
Toulouse, Haute Garonne, France
Limoges, Haute Vienne, France
Orleans, Loiret, France
Lille, Nord, France
Villejuif, Val De Marne, France
Paris, , France
Freiburg, Baden Wurttemberg, Germany
Tuebingen, Baden Wurttemberg, Germany
Regensburg, Bayern, Germany
Herne, Nordrhein Westfalen, Germany
Muenster, Nordrhein Westfalen, Germany
Halle, Sachsen Anhalt, Germany
Dresden, Sachsen, Germany
Athens, Attiki, Greece
Chaidari, Attiki, Greece
Larissa, Thessalia, Greece
Haifa, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Zerifin, , Israel
Pozzuoli, Napoli, Italy
Orbassano, Torino, Italy
Padova, Veneto, Italy
Verona, Veneto, Italy
Ancona, , Italy
Milano, , Italy
Nagoya, Aichi, Japan
Hirosaki, Aomori, Japan
Tsukuba, Ibaraki, Japan
Kanazawa, Ishikawa, Japan
Yokohama, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Sendai, Miyagi, Japan
Hamamatsu, Shizuoka, Japan
Gifu, , Japan
Nagasaki, , Japan
Okayama, , Japan
Osaka, , Japan
Osaka, , Japan
Tokyo, , Japan
Tokyo, , Japan
Toyama, , Japan
Jeollanam Do, Jeonranamdo, Korea, Republic Of
Gyeonggi Do, Kyonggi Do, Korea, Republic Of
Songpagu, Seoul, Korea, Republic Of
Daegu, Taegu Kwangyokshi, Korea, Republic Of
Incheon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Lembah Pantai, Kuala Lumpur, Malaysia
Kuching, Sarawak, Malaysia
Petaling Jaya, Selangor, Malaysia
Siedlce, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Przemysl, Podkarpackie, Poland
Koszalin, Zachodniopomorskie, Poland
Coimbra, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
Porto, , Portugal
Cluj Napoca, Cluj, Romania
Cluj Napoca, Cluj, Romania
Cluj Napoca, Cluj, Romania
Comuna Floresti, Cluj, Romania
Craiova, Dolj, Romania
Timisoara, Timis, Romania
Bucuresti, , Romania
Barnaul, Altayskiy Kray, Russian Federation
Obninsk, Kaluzskaja Oblast, Russian Federation
Moscow, Moskva, Russian Federation
Moscow, Moskva, Russian Federation
Nizhny Novgorod, Nizhegorodskaya Oblast, Russian Federation
Saint Petersburg, Sankt Peterburg, Russian Federation
Saint Petersburg, Sankt Peterburg, Russian Federation
Saint Petersburg, Sankt Peterburg, Russian Federation
Ekaterinburg, Sverdlovskaya Oblast, Russian Federation
Ekaterinburg, Sverdlovskaya Oblast, Russian Federation
Volzhsky, Volgogradskaya Oblast, Russian Federation
Singapore, Central Singapore, Singapore
Pretoria, Gauteng, South Africa
Oviedo, Asturias, Spain
Badalona, Barcelona, Spain
Manresa, Barcelona, Spain
Girona, Gerona, Spain
Santiago De Compostela, La Coruna, Spain
Las Palmas De Gran Canaria, Las Palmas, Spain
Barcelona, , Spain
Madrid, , Spain
Sevilla, , Spain
Dnipro, Dnipropetrovska Oblast, Ukraine
Dnipro, Dnipropetrovska Oblast, Ukraine
Kharkiv, Kharkivska Oblast, Ukraine
Kharkiv, Kharkivska Oblast, Ukraine
Kharkiv, Kharkivska Oblast, Ukraine
Lviv, Lvivska Oblast, Ukraine
Zhytomyr, Zhytomyrska Oblast, Ukraine
Plovdiv, , Bulgaria
Osaka, , Japan
Taichung, , Taiwan
Frankston, Victoria, Australia
Montreal, Quebec, Canada
Villejuif, Ile De France, France
Catania, , Italy
Poznan, Wielkopolskie, Poland
Cape Town, Western Cape, South Africa
San Francisco, California, United States
Indianapolis, Indiana, United States
Plovdiv, , Bulgaria
Patras, Achaia, Greece
George Town, Pulau Pinang, Malaysia
Johannesburg, Gauteng, South Africa
Sofia, , Bulgaria
Athens, Attiki, Greece
George Town, Pulau Pinang, Malaysia
Valencia, Valenciana, Comunitat, Spain
Verona, Veneto, Italy
Craiova, Dolj, Romania
Szolnok, Jasz Nagykun Szolnok, Hungary
Wrocław, Dolnoslaskie, Poland
Berlin, , Germany
Seoul, , Korea, Republic Of
Tel Aviv, , Israel
Panagyurishte, Pazardzhik, Bulgaria
Iloilo City, Iloilo, Philippines
Shanghai, Shanghai, China
Tokyo, , Japan
Szeged, Csongrad, Hungary
La Tronche, Isere, France
Medellin, Antioquia, Colombia
Cali, Valle Del Cauca, Colombia
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Medellin, Antioquia, Colombia
Abb, Caba, Argentina
Buenos Aires, Caba, Argentina
Rosario, Santa Fe, Argentina
Buenos Aires, , Argentina
Rosario, Santa Fe, Argentina
Piedecuesta, Santander, Colombia
Singapore, Central Singapore, Singapore
Montería, Cordoba, Colombia
Moscow, Moskva, Russian Federation
Girona, Gerona, Spain
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Bogota, Distrito Capital De Bogota, Colombia
Olomouc, , Czechia
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Wuerzburg, Bayern, Germany
Szolnok, Jasz Nagykun Szolnok, Hungary
Portland, Oregon, United States
Split, Splitsko Dalmatinska Zupanija, Croatia
Ramat Gan, , Israel
Padova, , Italy
Stanford, California, United States
Zagreb, Grad Zagreb, Croatia
Milan, Lombardia, Italy
Ancona, , Italy
Sagamihara, Kanagawa, Japan
Osaka, , Japan
Zagreb, Grad Zagreb, Croatia
Szolnok, Jasz Nagykun Szolnok, Hungary
Macquarie University, New South Wales, Australia
Okayama, , Japan
Torquay, Devon, United Kingdom
London, London, City Of, United Kingdom
Buenos Aires, , Argentina
George Town, Pulau Pinang, Malaysia
Winnipeg, Manitoba, Canada
Osijek, Osjecko Baranjska Zupanija, Croatia
Olomouc, , Czechia
Szolnok, Jasz Nagykun Szolnok, Hungary
Barnaul, Altayskiy Kray, Russian Federation
London, London, City Of, United Kingdom
Cluj, , Romania
Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials