Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer
NCT ID: NCT03682068
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1246 participants
INTERVENTIONAL
2018-09-27
2026-04-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Durvalumab in Combination with SoC Chemotherapy
Durvalumab every 3 weeks in concurrence with chemotherapy, followed by durvalumab monotherapy every 4 weeks.
All patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles:
* cisplatin+ gemcitabine
* If the patient is cisplatin-ineligible, carboplatin + gemcitabine
Durvalumab
Durvalumab IV (intravenous infusion)
Cisplatin + Gemcitabine
Cisplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
Carboplatin + Gemcitabine
Carboplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
Durvalumab in Combination with Tremelimumab+SoC Chemotherapy
Durvalumab and Tremelimumab every 3 weeks in concurrence with chemotherapy, followed by durvalumab monotherapy every 4 weeks
Tremelimumab will be provided for 4 cycles.
All patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles:
* cisplatin+ gemcitabine
* If the patient is cisplatin-ineligible, carboplatin + gemcitabine
Durvalumab
Durvalumab IV (intravenous infusion)
Tremelimumab
Tremelimumab IV (intravenous infusion)
Cisplatin + Gemcitabine
Cisplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
Carboplatin + Gemcitabine
Carboplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
SoC Chemotherapy
Patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles:
* cisplatin+ gemcitabine
* If the patient is cisplatin-ineligible, carboplatin + gemcitabine
Cisplatin + Gemcitabine
Cisplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
Carboplatin + Gemcitabine
Carboplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
Interventions
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Durvalumab
Durvalumab IV (intravenous infusion)
Tremelimumab
Tremelimumab IV (intravenous infusion)
Cisplatin + Gemcitabine
Cisplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
Carboplatin + Gemcitabine
Carboplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who have not been previously treated with first-line chemotherapy. Patients who have received prior definitive chemoradiation, adjuvant or neoadjuvant treatment for locally advanced disease are eligible provided that progression to locally advanced or metastatic disease has occurred \>12 months from the last therapy \[for chemoradiation and adjuvant treatment\] or \>12 months from the last surgery \[for neoadjuvant treatment\].
* At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion at baseline.
* World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment
* Adequate organ and marrow function as defined in the protocol
* Life expectancy ≥12 weeks in the opinion of the investigator
* Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.
Exclusion Criteria
* No severe concomitant condition that requires immunosuppression medication
* Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
* Patients who may be eligible for or are being considered for radical resection during the course of the study.
* Any medical contraindications to platinum (cisplatin or carboplatin) based doublet chemotherapy and/or known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Arezzo, , Italy
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Milan, , Italy
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Milan, , Italy
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Napoli, , Italy
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Orbassano, , Italy
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Parma, , Italy
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Pavia, , Italy
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Roma, , Italy
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Terni, , Italy
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Verona, , Italy
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Bunkyō City, , Japan
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Chūōku, , Japan
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Fukuoka, , Japan
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Hirosaki-shi, , Japan
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Kanazawa, , Japan
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Kita-gun, , Japan
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Koshigaya-shi, , Japan
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Kōtoku, , Japan
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Kumamoto, , Japan
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Kumamoto, , Japan
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Kyoto, , Japan
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Miyazaki, , Japan
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Nagasaki, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Shinjuku-ku, , Japan
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Suita-shi, , Japan
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Toyama, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Bacolod, , Philippines
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Baguio City, , Philippines
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Cebu, , Philippines
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Davao City, , Philippines
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Makati, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Bialystok, , Poland
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Gdansk, , Poland
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Grudziądz, , Poland
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Koszalin, , Poland
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Krakow, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Radom, , Poland
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Warsaw, , Poland
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Ivanovo, , Russia
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Nizhny Novgorod, , Russia
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Omsk, , Russia
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Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Tyumen, , Russia
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Vologda, , Russia
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Goyang-si, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Barcelona, , Spain
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Khon Kaen, , Thailand
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Mueang, , Thailand
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Songkhla, , Thailand
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Adana, , Turkey (Türkiye)
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Barcelona, , Spain
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Barcelona, , Spain
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Lugo, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Santander, , Spain
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Seville, , Spain
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Birmingham, Alabama, United States
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Bakersfield, California, United States
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Fullerton, California, United States
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Los Angeles, California, United States
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Salinas, California, United States
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Santa Barbara, California, United States
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Truckee, California, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Orlando, Florida, United States
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Chicago, Illinois, United States
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Fort Wayne, Indiana, United States
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Kansas City, Kansas, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Grand Rapids, Michigan, United States
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Bozeman, Montana, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Germantown, Tennessee, United States
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Fort Worth, Texas, United States
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Rosario, , Argentina
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Box Hill, , Australia
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Elizabeth Vale, , Australia
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Kogarah, , Australia
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Macquarie University, , Australia
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Murdoch, , Australia
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Orange, , Australia
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South Brisbane, , Australia
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St Albans, , Australia
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Curitiba, , Brazil
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Fortaleza, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Ribeirão Preto, , Brazil
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Rio de Janeiro, , Brazil
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Rio de Janeiro, , Brazil
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Salvador, , Brazil
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Santa Maria, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Hamilton, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Changsha, , China
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Changsha, , China
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Chongqing, , China
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Chongqing, , China
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Dalian, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Jinan, , China
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Nanchang, , China
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Nanjing, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Suzhou, , China
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Tianjin, , China
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Tianjin, , China
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Ürümqi, , China
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Wuhan, , China
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Xi'an, , China
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Brno, , Czechia
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Hradec Králové, , Czechia
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Olomouc, , Czechia
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Ostrava, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Győr, , Hungary
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Kecskemét, , Hungary
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Szolnok, , Hungary
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Gurgaon, , India
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Hubli, , India
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Kolkata, , India
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Mysuru, , India
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Nagpur, , India
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Nashik, , India
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New Delhi, , India
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New Delhi, , India
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Pune, , India
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Haifa, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Adapazarı, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Edirne, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Hanoi, , Vietnam
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Hanoi, , Vietnam
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Hà Nội, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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2018-001883-48
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D933SC00001
Identifier Type: -
Identifier Source: org_study_id
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