This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | September 27, 2018 | Phase 3 | Interventional |
Primary Outcome 1 - Measure: Overall Survival (OS)
Primary Outcome 1 - Time Frame: approximately 5 years
Criteria:
Key Inclusion Criteria:
- Patients with histologically or cytologically documented, unresectable, locally
advanced or metastatic transitional cell carcinoma (transitional cell and mixed
transitional/non-transitional cell histologies) of the urothelium (including renal
pelvis, ureters, urinary bladder, and urethra)
- 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.
Key Exclusion Criteria:
- Prior exposure to immune-mediated therapy (with exclusion of Bacillus Calmette
Guerin), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD L1, or
anti-PD-L2 antibodies, except therapeutic anticancer vaccines, which are permitted.
Prior local intervesical chemotherapy or immunotherapy is allowed if completed at
least 28 days prior to the initiation of study treatment.
- 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
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Gender: All
Minimum Age: 18 Years
Maximum Age: 130 Years
Healthy Volunteers: No
Name: AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
Email: information.center@astrazeneca.com
Facility | Status | Contact |
---|---|---|
Research Site Birmingham, Alabama 35294 United States |
Recruiting | |
Research Site Bakersfield, California 93309 United States |
Recruiting | |
Research Site Fullerton, California 92835 United States |
Recruiting | |
Research Site Salinas, California 93901 United States |
Recruiting | |
Research Site Santa Barbara, California 93105 United States |
Recruiting | |
Research Site Santa Maria, California 93454 United States |
Withdrawn | |
Research Site Santa Monica, California 90904 United States |
Recruiting | |
Research Site Truckee, California 96161 United States |
Terminated | |
Research Site New Haven, Connecticut 06520 United States |
Recruiting | |
Research Site Washington, District of Columbia 20007 United States |
Recruiting | |
Research Site Orlando, Florida 32806 United States |
Recruiting | |
Research Site Chicago, Illinois 60611 United States |
Recruiting | |
Research Site Fort Wayne, Indiana 46808 United States |
Recruiting | |
Research Site Kansas City, Kansas 66160 United States |
Recruiting | |
Research Site Louisville, Kentucky 40202 United States |
Recruiting | |
Research Site New Orleans, Louisiana 70112 United States |
Recruiting | |
Research Site Grand Rapids, Michigan 49503 United States |
Recruiting | |
Research Site Bozeman, Montana 59715 United States |
Suspended | |
Research Site Neptune, New Jersey 07754 United States |
Recruiting | |
Research Site Lake Success, New York 11042 United States |
Recruiting | |
Research Site New York, New York 10029 United States |
Recruiting | |
Research Site New York, New York 10065 United States |
Recruiting | |
Research Site Rochester, New York 14642 United States |
Recruiting | |
Research Site Sioux Falls, South Dakota 57104 United States |
Recruiting | |
Research Site Germantown, Tennessee 38138 United States |
Recruiting | |
Research Site Fort Worth, Texas 76104 United States |
Recruiting | |
Research Site Buenos Aires, C1120AAT Argentina |
Recruiting | |
Research Site Buenos Aires, C1426ANZ Argentina |
Recruiting | |
Research Site Ciudad de Buenos Aires, 1280 Argentina |
Recruiting | |
Research Site Ciudad de Buenos Aires, C1419AHL Argentina |
Recruiting | |
Research Site Rosario, S2000DEJ Argentina |
Recruiting | |
Research Site Box Hill, 3128 Australia |
Recruiting | |
Research Site Elizabeth Vale, 5112 Australia |
Recruiting | |
Research Site Kogarah, 2217 Australia |
Terminated | |
Research Site Macquarie University, 2109 Australia |
Recruiting | |
Research Site Murdoch, 6150 Australia |
Recruiting | |
Research Site Orange, 2800 Australia |
Recruiting | |
Research Site South Brisbane, 4101 Australia |
Terminated | |
Research Site St Albans, 3021 Australia |
Recruiting | |
Research Site Curitiba, 80810-050 Brazil |
Recruiting | |
Research Site Fortaleza, 60336-232 Brazil |
Recruiting | |
Research Site Porto Alegre, 90020-090 Brazil |
Recruiting | |
Research Site Porto Alegre, 90610-000 Brazil |
Recruiting | |
Research Site Porto Alegre, 91350-200 Brazil |
Recruiting | |
Research Site Ribeirão Preto, 14048-900 Brazil |
Recruiting | |
Research Site Rio de Janeiro, 20231-050 Brazil |
Recruiting | |
Research Site Rio de Janeiro, 22793-080 Brazil |
Recruiting | |
Research Site Salvador, 41950-640 Brazil |
Recruiting | |
Research Site Santa Maria, 97015-450 Brazil |
Recruiting | |
Research Site Sao Paulo, 01327-001 Brazil |
Recruiting | |
Research Site São José do Rio Preto, 15090-000 Brazil |
Recruiting | |
Research Site São Paulo, 01246-000 Brazil |
Recruiting | |
Research Site Burgas, 8000 Bulgaria |
Withdrawn | |
Research Site Pleven, 5800 Bulgaria |
Recruiting | |
Research Site Plovdiv, 4000 Bulgaria |
Recruiting | |
Research Site Sofia, 1303 Bulgaria |
Recruiting | |
Research Site Sofia, 1431 Bulgaria |
Recruiting | |
Research Site Sofia, 1527 Bulgaria |
Recruiting | |
Research Site Sofia, 1797 Bulgaria |
Recruiting | |
Research Site Varna, 9010 Bulgaria |
Recruiting | |
Research Site Calgary, Alberta T2N 4N2 Canada |
Recruiting | |
Research Site Edmonton, Alberta T6G 1Z2 Canada |
Recruiting | |
Research Site Vancouver, British Columbia V5Z 4E6 Canada |
Recruiting | |
Research Site Hamilton, Ontario L8V 5C2 Canada |
Recruiting | |
Research Site Ottawa, Ontario K1H 8L6 Canada |
Recruiting | |
Research Site Toronto, Ontario M5G IX6 Canada |
Recruiting | |
Research Site Montreal, Quebec H3T 1E2 Canada |
Recruiting | |
Research Site Beijing, 100034 China |
Not yet recruiting | |
Research Site Beijing, 100191 China |
Not yet recruiting | |
Research Site Beijing, 100730 China |
Not yet recruiting | |
Research Site Beijing, China |
Not yet recruiting | |
Research Site Changchun, 130021 China |
Recruiting | |
Research Site Changsha, 410008 China |
Recruiting | |
Research Site Changsha, 410013 China |
Recruiting | |
Research Site Chongqing, 400010 China |
Recruiting | |
Research Site Chongqing, 400038 China |
Recruiting | |
Research Site Dalian, 116027 China |
Not yet recruiting | |
Research Site Guangzhou, 510000 China |
Not yet recruiting | |
Research Site Guangzhou, 510060 China |
Recruiting | |
Research Site Hangzhou, 310003 China |
Recruiting | |
Research Site Hangzhou, 310009 China |
Recruiting | |
Research Site Hangzhou, 310014 China |
Recruiting | |
Research Site Hangzhou, 310022 China |
Recruiting | |
Research Site Jinan, 250012 China |
Recruiting | |
Research Site Nanchang, 330006 China |
Recruiting | |
Research Site Nanjing, 2100008 China |
Recruiting | |
Research Site Shanghai, 200032 China |
Recruiting | |
Research Site Shanghai, 200032 China |
Not yet recruiting | |
Research Site Shanghai, 200072 China |
Recruiting | |
Research Site Shanghai, 200127 China |
Not yet recruiting | |
Research Site Shenyang, 110001 China |
Recruiting | |
Research Site Suzhou, 215006 China |
Recruiting | |
Research Site Tianjin, 300211 China |
Not yet recruiting | |
Research Site Urumqi, 830000 China |
Recruiting | |
Research Site Xi'an, 710061 China |
Recruiting | |
Research Site Xiamen, 361003 China |
Recruiting | |
Research Site Brno, 656 91 Czechia |
Recruiting | |
Research Site Hradec Kralove, 500 05 Czechia |
Recruiting | |
Research Site Olomouc, 779 00 Czechia |
Recruiting | |
Research Site Ostrava, 708 52 Czechia |
Recruiting | |
Research Site Praha 2, 128 08 Czechia |
Recruiting | |
Research Site Praha, 140 59 Czechia |
Recruiting | |
Research Site Praha, 180 81 Czechia |
Recruiting | |
Research Site Budapest, 1062 Hungary |
Recruiting | |
Research Site Budapest, 1122 Hungary |
Recruiting | |
Research Site Budapest, 1145 Hungary |
Recruiting | |
Research Site Debrecen, 4032 Hungary |
Recruiting | |
Research Site Györ, 9024 Hungary |
Recruiting | |
Research Site Kecskemét, 6000 Hungary |
Recruiting | |
Research Site Szolnok, 5004 Hungary |
Recruiting | |
Research Site Ahmedabad, 380060 India |
Recruiting | |
Research Site Calicut, 673601 India |
Not yet recruiting | |
Research Site Gurgaon, 122001 India |
Recruiting | |
Research Site Hubli, 580025 India |
Recruiting | |
Research Site Kolkata, 700160 India |
Recruiting | |
Research Site Mysuru, 570017 India |
Recruiting | |
Research Site Nagpur, 440012 India |
Recruiting | |
Research Site Nasik, 422005 India |
Recruiting | |
Research Site New Delhi, 110085 India |
Recruiting | |
Research Site New Delhi, 11029 India |
Not yet recruiting | |
Research Site Pune, 411004 India |
Recruiting | |
Research Site Jerusalem, 91120 Israel |
Recruiting | |
Research Site Kfar Saba, 95847 Israel |
Recruiting | |
Research Site Petach-Tikva, 4941492 Israel |
Recruiting | |
Research Site Arezzo, 52100 Italy |
Recruiting | |
Research Site Milano, 20133 Italy |
Recruiting | |
Research Site Napoli, 80131 Italy |
Recruiting | |
Research Site Orbassano, 10043 Italy |
Recruiting | |
Research Site Parma, 43126 Italy |
Recruiting | |
Research Site Pavia, 27100 Italy |
Recruiting | |
Research Site Roma, 00168 Italy |
Recruiting | |
Research Site San Giovanni Rotondo, 71013 Italy |
Withdrawn | |
Research Site Terni, 05100 Italy |
Recruiting | |
Research Site Verona, 37134 Italy |
Recruiting | |
Research Site Bunkyo-ku, 113-8603 Japan |
Recruiting | |
Research Site Chuo-ku, 104-0045 Japan |
Recruiting | |
Research Site Fukuoka-shi, 811-1347 Japan |
Recruiting | |
Research Site Hirosaki-shi, 036-8563 Japan |
Recruiting | |
Research Site Kanazawa-shi, 920-8641 Japan |
Recruiting | |
Research Site Kita-gun, 761-0793 Japan |
Recruiting | |
Research Site Koshigaya-shi, 343-8555 Japan |
Recruiting | |
Research Site Koto-ku, 135-8550 Japan |
Recruiting | |
Research Site Kumamoto-shi, 860-0008 Japan |
Recruiting | |
Research Site Kumamoto-shi, 860-8556 Japan |
Recruiting | |
Research Site Kyoto-shi, 606-8507 Japan |
Recruiting | |
Research Site Miyazaki-city, 889-1692 Japan |
Recruiting | |
Research Site Nagasaki-shi, 852-8501 Japan |
Recruiting | |
Research Site Nagoya-shi, 466-8560 Japan |
Recruiting | |
Research Site Nagoya-shi, 467-0001 Japan |
Recruiting | |
Research Site Niigata-shi, 951-8520 Japan |
Recruiting | |
Research Site Osaka-shi, 541-8567 Japan |
Recruiting | |
Research Site Osaka-shi, 545-8586 Japan |
Recruiting | |
Research Site Osakasayama-shi, 589-8511 Japan |
Recruiting | |
Research Site Shinjuku-ku, 160-8582 Japan |
Recruiting | |
Research Site Suita-shi, 565-0871 Japan |
Recruiting | |
Research Site Toyama-shi, 930-0194 Japan |
Recruiting | |
Research Site Tsukuba-shi, 305-8576 Japan |
Withdrawn | |
Research Site Yokohama-shi, 232-0024 Japan |
Recruiting | |
Research Site Yokohama-shi, 241-8515 Japan |
Recruiting | |
Research Site Goyang-si, 10408 Korea, Republic of |
Recruiting | |
Research Site Incheon, 21565 Korea, Republic of |
Recruiting | |
Research Site Seoul, 02841 Korea, Republic of |
Recruiting | |
Research Site Seoul, 03722 Korea, Republic of |
Recruiting | |
Research Site Seoul, 05505 Korea, Republic of |
Recruiting | |
Research Site Seoul, 06351 Korea, Republic of |
Recruiting | |
Research Site Suwon-si, 442-723 Korea, Republic of |
Recruiting | |
Research Site Bacolod, 6100 Philippines |
Recruiting | |
Research Site Baguio City, 2600 Philippines |
Recruiting | |
Research Site Cebu, 6000 Philippines |
Recruiting | |
Research Site Davao City, 8000 Philippines |
Suspended | |
Research Site Iloilo City, Philippines |
Recruiting | |
Research Site Legazpi City, 4500 Philippines |
Recruiting | |
Research Site Makati, 1229 Philippines |
Suspended | |
Research Site Manila, 1015 Philippines |
Suspended | |
Research Site Quezon City, 1101 Philippines |
Recruiting | |
Research Site Quezon City, 1104 Philippines |
Recruiting | |
Research Site Bialystok, 15-027 Poland |
Recruiting | |
Research Site Gdańsk, 80-214 Poland |
Recruiting | |
Research Site Grudziądz, 86-300 Poland |
Suspended | |
Research Site Koszalin, 75-581 Poland |
Recruiting | |
Research Site Kraków, 30-688 Poland |
Recruiting | |
Research Site Olsztyn, 10-228 Poland |
Recruiting | |
Research Site Poznan, 60-693 Poland |
Recruiting | |
Research Site Radom, 26-600 Poland |
Recruiting | |
Research Site Warszawa, 02-781 Poland |
Recruiting | |
Research Site Ivanovo, 153040 Russian Federation |
Recruiting | |
Research Site Krasnoyarsk, 660133 Russian Federation |
Recruiting | |
Research Site Moscow, 105077 Russian Federation |
Recruiting | |
Research Site Moscow, 105229 Russian Federation |
Recruiting | |
Research Site Moscow, 115280 Russian Federation |
Recruiting | |
Research Site Moscow, 125284 Russian Federation |
Recruiting | |
Research Site Nizhniy Novgorod, 603074 Russian Federation |
Not yet recruiting | |
Research Site Nizhniy Novgorod, 603137 Russian Federation |
Recruiting | |
Research Site Omsk, 644013 Russian Federation |
Active, not recruiting | |
Research Site Rostov-on-Don, 344037 Russian Federation |
Recruiting | |
Research Site Saint-Petersburg, 195067 Russian Federation |
Recruiting | |
Research Site St. Petersburg, 197758 Russian Federation |
Recruiting | |
Research Site St. Petersburg, 199178 Russian Federation |
Recruiting | |
Research Site Vologda, 160012 Russian Federation |
Recruiting | |
Research Site Barcelona, 08908 Spain |
Recruiting | |
Research Site Barcelona, 8003 Spain |
Recruiting | |
Research Site Barcelona, 8035 Spain |
Recruiting | |
Research Site Lugo, 27003 Spain |
Recruiting | |
Research Site Madrid, 28007 Spain |
Recruiting | |
Research Site Madrid, 28034 Spain |
Recruiting | |
Research Site Madrid, 28040 Spain |
Recruiting | |
Research Site Malaga, 29010 Spain |
Recruiting | |
Research Site Santander, 39008 Spain |
Recruiting | |
Research Site Sevilla, 41013 Spain |
Recruiting | |
Research Site Taichung, 40443 Taiwan |
Recruiting | |
Research Site Taichung, 40705 Taiwan |
Recruiting | |
Research Site Tainan, 704 Taiwan |
Recruiting | |
Research Site Taipei City, 10050 Taiwan |
Recruiting | |
Research Site Taipei, 11217 Taiwan |
Recruiting | |
Research Site Tao-Yuan, 333 Taiwan |
Recruiting | |
Research Site Bangkok, 10300 Thailand |
Recruiting | |
Research Site Bangkok, 10400 Thailand |
Recruiting | |
Research Site Khon Kaen, 40002 Thailand |
Recruiting | |
Research Site Lampang, 52000 Thailand |
Recruiting | |
Research Site Muang, 50200 Thailand |
Recruiting | |
Research Site Songkla, 90110 Thailand |
Recruiting | |
Research Site Adana, 1260 Turkey |
Recruiting | |
Research Site Adapazari, 54290 Turkey |
Recruiting | |
Research Site Ankara, 06590 Turkey |
Recruiting | |
Research Site Edirne, 22030 Turkey |
Recruiting | |
Research Site Istanbul, 34030 Turkey |
Recruiting | |
Research Site Izmir, Turkey |
Recruiting | |
Research Site Hanoi, 100000 Vietnam |
Recruiting | |
Research Site Hanoi, 10000 Vietnam |
Recruiting | |
Research Site Ho Chi Minh city, 700000 Vietnam |
Withdrawn | |
Research Site Ho Chi Minh, 70000 Vietnam |
Recruiting |