Muscle Invasive Bladder Cancer Clinical Trial
— NIAGARAOfficial title:
A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer.
| Verified date | March 2024 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer
| Status | Active, not recruiting |
| Enrollment | 1063 |
| Est. completion date | June 30, 2026 |
| Est. primary completion date | June 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 130 Years |
| Eligibility | Inclusion: - Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology - Patients must be planning to undergo a radical cystectomy - Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC - ECOG performance status of 0 or 1 - Must have a life expectancy of at least 12 weeks at randomization Exclusion: - Evidence of lymph node (N2-N3) or metastatic (M1) disease at time of screening. - Prior pelvic radiotherapy treatment within 2 years of randomization to study - Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies. - Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product (IP). The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent; Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication) - Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. - Uncontrolled intercurrent illness - Active infection including Tuberculosis, Hepatitis B, Hepatitis C, and Human Immunodeficiency |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Research Site | Brisbane | |
| Australia | Research Site | Elizabeth Vale | |
| Australia | Research Site | Macquarie University | |
| Australia | Research Site | Melbourne | |
| Australia | Research Site | Murdoch | |
| Australia | Research Site | South Brisbane | |
| Belgium | Research Site | Brugge | |
| Belgium | Research Site | Charleroi | |
| Belgium | Research Site | Kortrijk | |
| Belgium | Research Site | Leuven | |
| Belgium | Research Site | Liège | |
| Belgium | Research Site | Roeselare | |
| Brazil | Research Site | Barretos | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Rio de Janeiro | |
| Brazil | Research Site | Santa Maria | |
| Brazil | Research Site | São José do Rio Preto | |
| Brazil | Research Site | Sao Paulo | |
| Brazil | Research Site | Sao Paulo | |
| Brazil | Research Site | São Paulo | |
| Brazil | Research Site | São Paulo | |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Ottawa | Ontario |
| Canada | Research Site | Sherbrooke | Quebec |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Vancouver | British Columbia |
| Chile | Research Site | Antofagasta | |
| Chile | Research Site | Puerto Montt | |
| Chile | Research Site | Santiago | |
| Chile | Research Site | Temuco | |
| Chile | Research Site | Temuco | |
| Chile | Research Site | Viña del Mar | |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Hradec Kralove | |
| Czechia | Research Site | Olomouc | |
| Czechia | Research Site | Praha | |
| Czechia | Research Site | Praha 2 | |
| Czechia | Research Site | Praha 8 | |
| France | Research Site | Angers Cedex 01 | |
| France | Research Site | Dijon | |
| France | Research Site | Grenoble Cedex 09 | |
| France | Research Site | Montpellier | |
| France | Research Site | Nimes | |
| France | Research Site | Pierre Benite | |
| France | Research Site | Poitiers Cedex | |
| France | Research Site | Rouen | |
| Germany | Research Site | Bergisch Gladbach | |
| Germany | Research Site | Bonn | |
| Germany | Research Site | Erlangen | |
| Germany | Research Site | Göttingen | |
| Germany | Research Site | Herne | |
| Germany | Research Site | Jena | |
| Germany | Research Site | Köln | |
| Germany | Research Site | Magdeburg | |
| Germany | Research Site | Mannheim | |
| Germany | Research Site | Münster | |
| Germany | Research Site | Nürnberg | |
| Germany | Research Site | Oldenburg | |
| Germany | Research Site | Regensburg | |
| Germany | Research Site | Ulm | |
| Germany | Research Site | Würzburg | |
| Israel | Research Site | Haifa | |
| Israel | Research Site | Jerusalem | |
| Israel | Research Site | Kfar Saba | |
| Israel | Research Site | Petach-Tikva | |
| Israel | Research Site | Ramat Gan | |
| Italy | Research Site | Bari | |
| Italy | Research Site | Bologna | |
| Italy | Research Site | Firenze | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Napoli | |
| Italy | Research Site | Orbassano | |
| Italy | Research Site | Pozzuoli | |
| Italy | Research Site | Verona | |
| Japan | Research Site | Bunkyo-ku | |
| Japan | Research Site | Fukuoka | |
| Japan | Research Site | Fukuoka-shi | |
| Japan | Research Site | Hirosaki-shi | |
| Japan | Research Site | Hiroshima-shi | |
| Japan | Research Site | Kanazawa-shi | |
| Japan | Research Site | Koto-ku | |
| Japan | Research Site | Kumamoto-shi | |
| Japan | Research Site | Miyazaki-city | |
| Japan | Research Site | Nagasaki-shi | |
| Japan | Research Site | Nagoya-shi | |
| Japan | Research Site | Niigata-shi | |
| Japan | Research Site | Osaka-shi | |
| Japan | Research Site | Osaka-shi | |
| Japan | Research Site | Osakasayama-shi | |
| Japan | Research Site | Sendai-shi | |
| Japan | Research Site | Toyama-shi | |
| Japan | Research Site | Tsukuba-shi | |
| Japan | Research Site | Yokohama-shi | |
| Japan | Research Site | Yokohama-shi | |
| Korea, Republic of | Research Site | Daegu | |
| Korea, Republic of | Research Site | Goyang-si | |
| Korea, Republic of | Research Site | Gyeonggi-do | |
| Korea, Republic of | Research Site | Incheon | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Breda | |
| Netherlands | Research Site | Rotterdam | |
| Philippines | Research Site | Baguio City | |
| Philippines | Research Site | Cebu | |
| Philippines | Research Site | Davao City | |
| Philippines | Research Site | Makati | |
| Philippines | Research Site | Manila | |
| Philippines | Research Site | Quezon City | |
| Philippines | Research Site | Quezon City | |
| Poland | Research Site | Bialystok | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Grudziadz | |
| Poland | Research Site | Koszalin | |
| Poland | Research Site | Kraków | |
| Poland | Research Site | Olsztyn | |
| Poland | Research Site | Ostroleka | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Wroclaw | |
| Russian Federation | Research Site | Krasnoyarsk | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Nizhniy Novgorod | |
| Russian Federation | Research Site | Novosibirsk | |
| Russian Federation | Research Site | Samara | |
| Russian Federation | Research Site | St Petersburg | |
| Russian Federation | Research Site | St. Petersburg | |
| Russian Federation | Research Site | St. Petersburg | |
| Russian Federation | Research Site | St. Petersburg | |
| Russian Federation | Research Site | Ufa | |
| Russian Federation | Research Site | Vologda | |
| Spain | Research Site | Badalona | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Córdoba | |
| Spain | Research Site | Las Palmas de Gran Canaria | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Santander | |
| Spain | Research Site | Sevilla | |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Tainan | |
| Taiwan | Research Site | Tainan | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei City | |
| Taiwan | Research Site | Taoyuan City | |
| Turkey | Research Site | Ankara | |
| Turkey | Research Site | Edirne | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Izmir | |
| Turkey | Research Site | Karsiyaka | |
| United Kingdom | Research Site | Edinburgh | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | Nottingham | |
| United Kingdom | Research Site | Sheffield | |
| United Kingdom | Research Site | Wirral | |
| United States | Research Site | Ann Arbor | Michigan |
| United States | Research Site | Bethlehem | Pennsylvania |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Burlington | Vermont |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site | Geneva | Illinois |
| United States | Research Site | Iowa City | Iowa |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | New Haven | Connecticut |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | New York | New York |
| United States | Research Site | Palo Alto | California |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Towson | Maryland |
| United States | Research Site | Westwood | Kansas |
| Vietnam | Research Site | Hanoi | |
| Vietnam | Research Site | Ho Chi Minh | |
| Vietnam | Research Site | Hochiminh |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Vietnam, Australia, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Israel, Italy, Japan, Korea, Republic of, Netherlands, Philippines, Poland, Russian Federation, Spain, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pathologic complete response (pCR) rates at time of cystectomy | Up to 6 months | ||
| Primary | Event-free survival (EFS) per central review defined as time from randomization to event | Up to 48 months | ||
| Secondary | Proportion of patients who achieve <P2 at time of cystectomy | Up to 6 months | ||
| Secondary | EFS at 24 months (EFS24) defined as time from randomization to event | Up to 24 months | ||
| Secondary | Proportion of patients who undergo cystectomy | Up to 6 months | ||
| Secondary | Overall survival rate at 5 years | Up to 60 months | ||
| Secondary | PFS2 defined as time from randomization to event following subsequent therapy | Up to 84 months | ||
| Secondary | Safety and Tolerability as evaluated by adverse events occurring throughout the study | Up to 84 months | ||
| Secondary | Immunogenicity of durvalumab when used in combination with gemcitabine/cisplatin as measured by presence of antidrug antibodies (ADA) | Up to 12 months | ||
| Secondary | Overall Survival | Up to 84 months | ||
| Secondary | Metastasis-free survival per investigator assessment or local biopsy review. | Up to 48 months | ||
| Secondary | Disease-specific survival per investigator assessment or local biopsy review. | up to 48 months | ||
| Secondary | Disease-free survival | Up to 48 months |
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