A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab Plus Docetaxel Versus Placebo Plus Docetaxel in Patients With Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or After Platinum-Based Therapy
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab Plus Docetaxel Versus Placebo Plus Docetaxel in Patients With Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or After Platinum-Based Therapy
The main purpose of this study is to evaluate the safety and efficacy of the study drug ramucirumab in combination with docetaxel in participants with urothelial cancer who failed prior platinum-based therapy.
Inclusion Criteria:
Have histologically or cytologically confirmed, locally advanced or unresectable or metastatic urothelial (transitional cell) carcinoma of the bladder, urethra, ureter, or renal pelvis.
Had disease progression while on a platinum containing regimen in the first-line setting or within 14 months after completing the first-line platinum regimen. Participants who received treatment with one immune checkpoint inhibitor regimen are eligible (for example Programmed death 1 (PD-1), Programmed death-ligand 1 (PDL1), or CTLA4) and may have a longer interval since prior platinum-containing therapy (≤24 months).
Have a life expectancy of ≥3 months.
Have received no more than one prior systemic chemotherapy regimen in the relapsed or metastatic setting. Prior treatment with no more than one prior immune checkpoint inhibitor is permitted and will not be considered as a line of systemic chemotherapy.
Have measurable disease or nonmeasurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
Have an Eastern Cooperative Oncology Group (ECOG) of 0 or 1.
Have adequate hematologic function.
Have adequate coagulation function.
Have adequate hepatic function.
The participant does not have:
Have adequate renal function as defined by creatinine clearance >30 milliliters/minute.
Have urinary protein ≤1+ on dipstick or routine urinalysis.
The participant is willing to provide blood, urine, and tissue samples for research purposes.
Exclusion Criteria:
Adelaide, 5000, Australia
Footscray, 3011, Australia
Randwick, 2031, Australia
Subiaco, 6008, Australia
Brussels, 1200, Belgium
Leuven, 3000, Belgium
Wilrijk, 2610, Belgium
Toronto, M4N 3M5, Canada
Vancouver, V5Z 4E6, Canada
Herlev, 2730, Denmark
Odense, 5000, Denmark
Caen, 14076, France
Lille, 59020, France
Lyon, 69373, France
Montpellier, 34070, France
Paris, 75015, France
Rennes, 35062, France
Düsseldorf, 40225, Germany
Freiburg im Breisgau, 79106, Germany
Homburg, 66421, Germany
Jena, 07740, Germany
Marburg, 35043, Germany
Tübingen, 72076, Germany
Athens, 11528, Greece
Heraklion, 71110, Greece
Pátrai, 26504, Greece
Thessaloniki, 56403, Greece
Budapest, 1122, Hungary
Miskolc, 3526, Hungary
Haifa, 3525408, Israel
Kfar Saba, 4428164, Israel
Petah Tikva, 4941492, Israel
Tel Aviv, 6423906, Israel
Tel Litwinsky, 5265601, Israel
Ẕerifin, 6093000, Israel
Arezzo, 52100, Italy
Bologna, 40138, Italy
Milan, 20133, Italy
Orbassano, 10043, Italy
Rome, 00152, Italy
Verona, 37134, Italy
Bunkyō City, 113-8431, Japan
Chiba, 260-8717, Japan
Fukuoka, 812-8582, Japan
Hidaka, 350-1298, Japan
Hirosaki, 036-8563, Japan
Kashiwa, 277-8577, Japan
Kita-gun, 761-0793, Japan
Kobe, 650-0047, Japan
Matsuyama, 791-0280, Japan
Morioka, 020-8505, Japan
Niigata, 951-8520, Japan
Osaka, 541-8567, Japan
Sapporo, 060-8543, Japan
Sendai, 980-8574, Japan
Suita-shi, 565-0871, Japan
Tokyo, 135-8550, Japan
Tsukuba, 305-8576, Japan
Aguascalientes, 20230, Mexico
Culiacán, 80020, Mexico
México, 06760, Mexico
Monterrey, 64570, Mexico
Morelia, 58260, Mexico
Amsterdam, 1066 CX, Netherlands
Arnhem, 6815 AD, Netherlands
Maastricht, 6229 HX, Netherlands
Rotterdam, 3075 EA, Netherlands
Sittard, 6162 BG, Netherlands
Gdansk, 80-219, Poland
Poznan, 60-569, Poland
Warsaw, 04-125, Poland
Wieliszew, 05-135, Poland
Baia Mare, 430110, Romania
Cluj-Napoca, 400058, Romania
Craiova, 200347, Romania
Saratov, 410054, Russia
Daejeon, 35015, South Korea
Seongnam, 463-707, South Korea
Seongnam-si, 13620, South Korea
Seoul, 03181, South Korea
Seoul, 03722, South Korea
Seoul, 05505, South Korea
Seoul, 06351, South Korea
Badajoz, 06080, Spain
Barcelona, 08907, Spain
Madrid, 28034, Spain
Kaohsiung City, 83301, Taiwan
Taichung, 40705, Taiwan
Tainan, 71004, Taiwan
Taipei, 100, Taiwan
Ankara, 06100, Turkey (Türkiye)
Antalya, 07059, Turkey (Türkiye)
Edirne, 22030, Turkey (Türkiye)
Istanbul, 34098, Turkey (Türkiye)
Malatya, 44280, Turkey (Türkiye)
Dnipropetrovsk, 49102, Ukraine
Kyiv, 04107, Ukraine
Lutsk, 63000, Ukraine
Bebington, CH63 4JY, United Kingdom
Chelsea, W6 8RF, United Kingdom
London, EC1A 7BE, United Kingdom
Nottingham, NG5 1PB, United Kingdom
Southampton, SO16 6YD, United Kingdom