Bladder Cancer Clinical Trial
Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer
Summary
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).
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 228 Locations for this study
Birmingham Alabama, 35294, United States
Bakersfield California, 93309, United States
Fullerton California, 92835, United States
Los Angeles California, 90095, United States
Salinas California, 93901, United States
Santa Barbara California, 93105, United States
Truckee California, 96161, United States
New Haven Connecticut, 06520, United States
Washington District of Columbia, 20007, United States
Orlando Florida, 32806, United States
Chicago Illinois, 60611, United States
Fort Wayne Indiana, 46804, United States
Kansas City Kansas, 66160, United States
Louisville Kentucky, 40202, United States
New Orleans Louisiana, 70112, United States
Grand Rapids Michigan, 49503, United States
Bozeman Montana, 59715, United States
New Hyde Park New York, 11042, United States
New York New York, 10029, United States
New York New York, 10065, United States
Rochester New York, 14642, United States
Sioux Falls South Dakota, 57104, United States
Germantown Tennessee, 38138, United States
Fort Worth Texas, 76104, United States
Buenos Aires , C1120, Argentina
Buenos Aires , C1426, Argentina
Ciudad de Buenos Aires , 1280, Argentina
Ciudad de Buenos Aires , C1419, Argentina
Rosario , S2000, Argentina
Box Hill , 3128, Australia
Elizabeth Vale , 5112, Australia
Kogarah , 2217, Australia
Macquarie University , 2109, Australia
Murdoch , 6150, Australia
Orange , 2800, Australia
South Brisbane , 4101, Australia
St Albans , 3021, Australia
Curitiba , 80810, Brazil
Fortaleza , 60336, Brazil
Porto Alegre , 90020, Brazil
Porto Alegre , 90610, Brazil
Porto Alegre , 91350, Brazil
Ribeirão Preto , 14048, Brazil
Rio de Janeiro , 20231, Brazil
Rio de Janeiro , 22793, Brazil
Salvador , 41.95, Brazil
Santa Maria , 97015, Brazil
Sao Paulo , 01327, Brazil
São José do Rio Preto , 15090, Brazil
São Paulo , 01246, Brazil
Pleven , 5800, Bulgaria
Plovdiv , 4000, Bulgaria
Sofia , 1303, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1527, Bulgaria
Sofia , 1797, Bulgaria
Varna , 9010, Bulgaria
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Hamilton Ontario, L8V 5, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G I, Canada
Montreal Quebec, H3T 1, Canada
Beijing , 10003, China
Beijing , 10003, China
Beijing , 10014, China
Beijing , 10019, China
Beijing , 10073, China
Beijing , , China
Changchun , 13002, China
Changsha , 41000, China
Changsha , 41001, China
Chongqing , 40003, China
Chongqing , 40004, China
Dalian , 11602, China
Guangzhou , 51000, China
Guangzhou , 51006, China
Guangzhou , 51028, China
Hangzhou , 31000, China
Hangzhou , 31000, China
Hangzhou , 31001, China
Hangzhou , 31002, China
Jinan , 25001, China
Nanchang , 33000, China
Nanjing , 21000, China
Shanghai , 20000, China
Shanghai , 20003, China
Shanghai , 20007, China
Shanghai , 20012, China
Shenyang , 11000, China
Suzhou , 21500, China
Tianjin , 30021, China
Tianjin , , China
Urumqi , 83000, China
Wuhan , 43002, China
Xi'an , 71006, China
Xiamen , 36100, China
Brno , 656 9, Czechia
Hradec Kralove , 500 0, Czechia
Olomouc , 77900, Czechia
Ostrava , 708 5, Czechia
Praha 2 , 128 0, Czechia
Praha 8 , 180 8, Czechia
Praha , 140 5, Czechia
Budapest , 1062, Hungary
Budapest , 1122, Hungary
Budapest , 1145, Hungary
Debrecen , 4032, Hungary
Győr , 9024, Hungary
Kecskemét , 6000, Hungary
Szolnok , 5004, Hungary
Ahmedabad , 38001, India
Ahmedabad , 38006, India
Calicut , 67360, India
Gurgaon , 12200, India
Hubli , 58002, India
Hyderabad , 50008, India
Kolkata , 70016, India
Mysuru , 57001, India
Nagpur , 44001, India
Nasik , 42200, India
New Delhi , 11006, India
New Delhi , 11008, India
New Delhi , 11029, India
Pune , 41100, India
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Kfar Saba , 95847, Israel
Petach-Tikva , 49414, Israel
Ramat Gan , 52621, Israel
Arezzo , 52100, Italy
Milano , 20132, Italy
Milano , 20133, Italy
Napoli , 80131, Italy
Orbassano , 10043, Italy
Parma , 43126, Italy
Pavia , 27100, Italy
Roma , 00100, Italy
Terni , 05100, Italy
Verona , 37134, Italy
Bunkyo-ku , 113-8, Japan
Chuo-ku , 104-0, Japan
Fukuoka-shi , 811-1, Japan
Hirosaki-shi , 036-8, Japan
Kanazawa-shi , 920-8, Japan
Kita-gun , 761-0, Japan
Koshigaya-shi , 343-8, Japan
Koto-ku , 135-8, Japan
Kumamoto-shi , 860-0, Japan
Kumamoto-shi , 860-8, Japan
Kyoto-shi , 606-8, Japan
Miyazaki-city , 889-1, Japan
Nagasaki-shi , 852-8, Japan
Nagoya-shi , 466-8, Japan
Nagoya-shi , 467-0, Japan
Niigata-shi , 951-8, Japan
Osaka-shi , 541-8, Japan
Osaka-shi , 545-8, Japan
Osakasayama-shi , 589-8, Japan
Shinjuku-ku , 160-8, Japan
Suita-shi , 565-0, Japan
Toyama-shi , 930-0, Japan
Yokohama-shi , 232-0, Japan
Yokohama-shi , 241-8, Japan
Goyang-si , 10408, Korea, Republic of
Incheon , 21565, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Suwon , 16247, Korea, Republic of
Bacolod , 6100, Philippines
Baguio City , 2600, Philippines
Cebu , 6000, Philippines
Davao City , 8000, Philippines
Iloilo City , , Philippines
Legazpi City , 4500, Philippines
Makati , 1229, Philippines
Manila , 1015, Philippines
Quezon City , 1101, Philippines
Quezon City , 1104, Philippines
Bialystok , 15-02, Poland
Gdańsk , 80-21, Poland
GrudziÄ…dz , 86-30, Poland
Koszalin , 75-58, Poland
Kraków , 30-68, Poland
Olsztyn , 10-22, Poland
Poznan , 60-69, Poland
Radom , 26-60, Poland
Warszawa , 02-78, Poland
Ivanovo , 15304, Russian Federation
Krasnoyarsk , 66013, Russian Federation
Moscow , 10507, Russian Federation
Moscow , 10522, Russian Federation
Moscow , 11528, Russian Federation
Moscow , 12528, Russian Federation
Nizhniy Novgorod , 60307, Russian Federation
Nizhniy Novgorod , 60313, Russian Federation
Omsk , 64401, Russian Federation
Rostov-on-Don , 34403, Russian Federation
Saint-Petersburg , 19506, Russian Federation
St. Petersburg , 19775, Russian Federation
St. Petersburg , 19917, Russian Federation
Tyumen , 62504, Russian Federation
Vologda , 16001, Russian Federation
Barcelona , 08908, Spain
Barcelona , 8003, Spain
Barcelona , 8035, Spain
Lugo , 27003, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Malaga , 29010, Spain
Santander , 39008, Spain
Sevilla , 41013, Spain
Taichung , 404, Taiwan
Taichung , 40705, Taiwan
Tainan , 704, Taiwan
Taipei City , 10050, Taiwan
Taipei , 11217, Taiwan
Taoyuan , 333, Taiwan
Bangkok , 10300, Thailand
Bangkok , 10400, Thailand
Khon Kaen , 40002, Thailand
Lampang , 52000, Thailand
Mueang , 50200, Thailand
Songkla , 90110, Thailand
Adana , 1260, Turkey
Adapazari , 54290, Turkey
Ankara , 06590, Turkey
Edirne , 22030, Turkey
Istanbul , 34030, Turkey
Izmir , , Turkey
Ha Noi , 10000, Vietnam
Hanoi , 10000, Vietnam
Hanoi , 10000, Vietnam
Ho Chi Minh , 70000, Vietnam
How clear is this clinincal trial information?