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 Mus

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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

Condition: Muscle Invasive Bladder Cancer

Intervention:

  • Drug: Durvalumab
  • Drug: Cisplatin
  • Drug: Gemcitabine

Purpose: 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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03732677

Sponsor: AstraZeneca

Primary Outcome Measures:

  • Measure: Pathologic complete response (pCR) rates at time of cystectomy following neoadjuvant treatment, as assessed by central pathology review
  • Time Frame: Up to 6 months
  • Safety Issue:
  • Measure: Event-free survival (EFS) per central review defined as time from randomization to the first recurrence of disease (after cystectomy), or progression in patients who were precluded for cystectomy, or death due to any cause, whichever occurs first
  • Time Frame: Up to 48 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Proportion of patients who achieve
  • Time Frame: Up to 6 months
  • Safety Issue:
  • Measure: EFS at 24 months (EFS24) defined as time from randomization to the first recurrence of disease (after cystectomy), or first progression in patients who were precluded for cystectomy, or death due to any cause, whichever occurs first
  • Time Frame: Up to 24 months
  • Safety Issue:
  • Measure: Proportion of patients who undergo cystectomy
  • Time Frame: Up to 6 months
  • Safety Issue:
  • Measure: Overall survival rate at 5 years, as determined based on time from date of randomization to date of death, from any cause
  • Time Frame: Up to 60 months
  • Safety Issue:
  • Measure: PFS2 defined as the time from the date of randomization to the earliest date of progression which occurs on subsequent therapy following an EFS event or death
  • Time Frame: Up to 84 months
  • Safety Issue:
  • Measure: Safety and Tolerability as evaluated by adverse events occurring throughout the study
  • Time Frame: Up to 84 months
  • Safety Issue:
  • Measure: Immunogenicity of durvalumab when used in combination with gemcitabine/cisplatin as measured by presence of antidrug antibodies (ADA)
  • Time Frame: Up to 12 months
  • Safety Issue:

Estimated Enrollment: 1050

Study Start Date: November 16, 2018

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum 130 Years
  • Gender: All

Criteria: Inclusion: – Patient resectable muscle-invasive bladder cancer with clinical stage T2N0M0-T4aN0M0 with transitional cell histology – Patients must be planning to undergo a radical cystectomy at the time of randomization – 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 or metastatic 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

Contact:

  • AstraZeneca Clinical Study Information Center
  • information.center@astrazeneca.com
  • 1-877-240-9479

Locations:

  • Research Site
  • Birmingham Alabama 35294 United States
  • Research Site
  • Fountain Valley California 92708 United States
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  • Fullerton California 92835 United States
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  • Los Angeles California 90095 United States
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  • Monterey California 93940 United States
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  • Salinas California 93901 United States
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  • Santa Rosa California 95403 United States
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  • Stanford California 94305-5824 United States
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  • Denver Colorado 80211 United States
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  • New Haven Connecticut 06520 United States
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  • Tampa Florida 33612 United States
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  • Chicago Illinois 60611 United States
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  • Iowa City Iowa 52242 United States
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  • Westwood Kansas 66205 United States
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  • Louisville Kentucky 40202 United States
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  • New Orleans Louisiana 70112 United States
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  • New Orleans Louisiana 70121 United States
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  • Baltimore Maryland 21204 United States
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  • Ann Arbor Michigan 48109 United States
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  • Detroit Michigan 48201 United States
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  • Neptune New Jersey 07754 United States
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  • New Brunswick New Jersey 08903 United States
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  • New York New York 10029 United States
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  • Rochester New York 14642 United States
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  • Durham North Carolina 27710 United States
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  • Columbus Ohio 43210 United States
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  • Bethlehem Pennsylvania 18015 United States
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  • Providence Rhode Island 02903 United States
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  • Burlington Vermont 05401 United States
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  • Milwaukee Wisconsin 53226 United States
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  • Box Hill 3128 Australia
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  • Elizabeth Vale 5112 Australia
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  • Herston 4029 Australia
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  • Macquarie University 2109 Australia
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  • Murdoch 6150 Australia
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  • Prahran 3004 Australia
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  • South Brisbane 4101 Australia
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  • Brugge 8000 Belgium
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  • Charleroi 6000 Belgium
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  • Kortrijk 8500 Belgium
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  • Leuven 3000 Belgium
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  • Liège 4000 Belgium
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  • Barretos 14784-400 Brazil
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  • Passo Fundo 99010-080 Brazil
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  • Porto Alegre 90020-090 Brazil
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  • Porto Alegre 90470-340 Brazil
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  • Porto Alegre 90610-000 Brazil
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  • Porto Alegre 91350-200 Brazil
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  • Rio de Janeiro 20231-050 Brazil
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  • Sao Paulo 01323-903 Brazil
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  • Sao Paulo 01509-900 Brazil
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  • Sao Paulo 04101-000 Brazil
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  • São José do Rio Preto 15090-000 Brazil
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  • São Paulo 01246-000 Brazil
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  • São Paulo 03102-002 Brazil
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  • Edmonton Alberta T6G 1Z2 Canada
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  • Vancouver British Columbia V5Z 4E6 Canada
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  • Hamilton Ontario L8V 5C2 Canada
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  • London Ontario N6A 5W9 Canada
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  • Ottawa Ontario K1H 8L6 Canada
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  • Toronto Ontario M5G IX6 Canada
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  • Montreal Quebec H2X 0C2 Canada
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  • Sherbrooke Quebec J1H 5N4 Canada
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  • Antofagasta 1267348 Chile
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  • Puerto Montt 5480000 Chile
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  • Santiago de Chile 6770128 Chile
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  • Santiago 7520349 Chile
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  • Temuco 4810218 Chile
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  • Viña del Mar 2540488 Chile
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  • Brno 656 53 Czechia
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  • Hradec Kralove 500 05 Czechia
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  • Olomouc 779 00 Czechia
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  • Praha 5 150 06 Czechia
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  • Praha 180 81 Czechia
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  • Angers Cedex 01 49033 France
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  • Dijon 21079 France
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  • Grenoble Cedex 09 38043 France
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  • Montpellier 34070 France
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  • Nimes 30029 France
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  • Pierre Benite 69495 France
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  • Poitiers Cedex 86021 France
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  • Rouen F-76031 CE France
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  • Bonn 53127 Germany
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  • Köln 50937 Germany
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  • Magdeburg 39120 Germany
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  • Nürnberg 90491 Germany
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  • Ulm 89081 Germany
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  • Würzburg 97080 Germany
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  • Haifa 31096 Israel
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  • Jerusalem 91120 Israel
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  • Kfar Saba 95847 Israel
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  • Petach-Tikva 4941492 Israel
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  • Ramat Gan 52621 Israel
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  • Bari 70124 Italy
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  • Bologna 40138 Italy
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  • Firenze 50134 Italy
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  • Milano 20133 Italy
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  • Napoli 80131 Italy
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  • Orbassano 10043 Italy
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  • Verona 37134 Italy
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  • Bunkyo-ku 113-8603 Japan
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  • Fukuoka-shi 811-1347 Japan
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  • Fukuoka 812-8582 Japan
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  • Hirosaki-shi 036-8563 Japan
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  • Hiroshima-shi 730-8518 Japan
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  • Kanazawa-shi 920-8641 Japan
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  • Koto-ku 135-8550 Japan
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  • Kumamoto-shi 860-0008 Japan
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  • Miyazaki-city 889-1692 Japan
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  • Nagasaki-shi 852-8501 Japan
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  • Nagoya-shi 466-8560 Japan
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  • Niigata-shi 951-8520 Japan
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  • Osaka-shi 541-8567 Japan
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  • Osaka-shi 545-8586 Japan
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  • Osakasayama-shi 589-8511 Japan
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  • Sendai-shi 980-0872 Japan
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  • Shinjuku-ku 160-8582 Japan
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  • Toyama-shi 930-0194 Japan
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  • Tsukuba-shi 305-8576 Japan
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  • Yokohama-shi 232-0024 Japan
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  • Yokohama-shi 241-8515 Japan
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  • Daegu 41404 Korea, Republic of
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  • Goyang-si 10408 Korea, Republic of
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  • Incheon 21565 Korea, Republic of
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  • Seongnam 13620 Korea, Republic of
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  • Seoul 03080 Korea, Republic of
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  • Seoul 136-705 Korea, Republic of
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  • Amsterdam 1066 CX Netherlands
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  • Amsterdam 1081 HV Netherlands
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  • Breda 4819 EV Netherlands
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  • Rotterdam 3015 GD Netherlands
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  • Baguio City 2600 Philippines
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  • Cebu 6000 Philippines
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  • Davao City 8000 Philippines
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  • Makati 1229 Philippines
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  • Manila 1015 Philippines
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  • Quezon City 1101 Philippines
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  • Quezon City 1104 Philippines
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  • Bialystok 15-027 Poland
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  • Gdańsk 80-214 Poland
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  • Grudziądz 86-300 Poland
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  • Koszalin 75-581 Poland
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  • Olsztyn 10-228 Poland
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  • Poznan 60-693 Poland
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  • Radom 26-600 Poland
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  • Warszawa 02-781 Poland
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  • Wroclaw 53-413 Poland
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  • Ivanovo 153040 Russian Federation
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  • Krasnoyarsk 660133 Russian Federation
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  • Moscow 105077 Russian Federation
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  • Nizhniy Novgorod 603074 Russian Federation
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  • Omsk 644013 Russian Federation
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  • Samara 443031 Russian Federation
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  • St. Petersburg 194017 Russian Federation
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  • St. Petersburg 194354 Russian Federation
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  • Vologda 160012 Russian Federation
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  • Badalona 08916 Spain
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  • Barcelona 08035 Spain
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  • Córdoba 14004 Spain
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  • Las Palmas de Gran Canaria 35016 Spain
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  • Madrid 28007 Spain
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  • Madrid 28041 Spain
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  • Santander 39008 Spain
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  • Sevilla 41013 Spain
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  • Kaohsiung 807 Taiwan
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  • Taichung 404 Taiwan
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  • Taichung 40705 Taiwan
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  • Tainan 704 Taiwan
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  • Tainan 710 Taiwan
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  • Taipei City 10050 Taiwan
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  • Taipei 11217 Taiwan
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  • Taoyuan City 333 Taiwan
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  • Ankara 06590 Turkey
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  • Edirne 22030 Turkey
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  • Istanbul 34030 Turkey
  • Research Site
  • Izmir Turkey
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  • Edinburgh EH4 2XR United Kingdom
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  • Guildford GU2 7WG United Kingdom
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  • London EC1A 7BE United Kingdom
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  • Nottingham NG5 1PB United Kingdom
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  • Sheffield S10 2SJ United Kingdom
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  • Wirral CH63 4JY United Kingdom
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  • Hanoi 100000 Vietnam
  • Research Site
  • Ho Chi Minh city 700000 Vietnam
  • Research Site
  • Ho Chi Minh 700000 Vietnam
  • Research Site
  • Hochiminh 700000 Vietnam

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