Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
NCT ID: NCT03547973
Last Updated: 2025-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
827 participants
INTERVENTIONAL
2018-08-13
2030-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Sacituzumab Govitecan-hziy (SG)
Participants with urothelial cancer (UC) previously treated with platinum-based and/or checkpoint inhibitors (CPIs) will receive SG 10 mg/kg intravenously (IV) on Days 1 and 8 of a 21-day cycle.
Sacituzumab Govitecan-hziy
Administered intravenously.
Cohort 2: SG
Participants with UC who are ineligible for platinum-based therapy and failed therapy with previous immune CPI therapy will receive SG 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle.
Sacituzumab Govitecan-hziy
Administered intravenously.
Cohort 3: SG + Pembrolizumab
Participants who have had progression or recurrence of UC following a platinum-containing regimen in the metastatic setting, or progression or recurrence of UC within 12 months of completion of platinum-based therapy as neoadjuvant or adjuvant therapy will receive SG 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle and pembrolizumab at the standard approved dose (200 mg) only on Day 1 of a 21-day cycle. Lower doses of SG may be tested based on dose-limiting toxicities (DLTs) observed to determine the Recommended Phase 2 Dose (RP2D) of SG in combination with pembrolizumab.
Sacituzumab Govitecan-hziy
Administered intravenously.
Pembrolizumab
Administered per package insert
Cohort 4: SG + Cisplatin + Avelumab (Dose Escalation Phase)
Participants with UC who have never received therapy with platinum in the metastatic setting or for unresectable locally advanced disease will first receive cisplatin (either at 70 mg/m\^2 on Day 1 of a 21-day cycle or at a split dose of 35 mg/m\^2 on Days 1 and 8 of a 21-day cycle with a maximum body surface area of 2) and sacituzumab govitecan-hziy with maximum dose of 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle for up to 6 cycles. Based on DLTs observed, two additional lower doses may be tested to determine RP2D of sacituzumab govitecan-hziy in combination with cisplatin. If premature termination of 1 agent occurs due to toxicity, the other agent may be continued to complete up to 6 cycles of therapy. For participants who have not progressed, maintenance therapy will begin with infusions of avelumab 800 mg every 2 weeks beginning on Cycle 1, Day 1 and every 2 weeks thereafter and sacituzumab govitecan-hziy 10 mg/kg on Days 1 and 8 every 21 days.
Sacituzumab Govitecan-hziy
Administered intravenously.
Cisplatin
Administered per package insert
Avelumab
Administered per package insert
Cohort 4: SG + Cisplatin + Zimberelimab (ZIM) (Dose Expansion Phase)
Participants with UC who have never received therapy with platinum in the metastatic setting or for unresectable locally advanced disease will first receive cisplatin (either at 70 mg/m\^2 on Day 1 of a 21-day cycle or at a split dose of 35 mg/m\^2 on Days 1 and 8 of a 21-day cycle with a maximum body surface area of 2) and sacituzumab govitecan-hziy with maximum dose of 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle for up to 6 cycles. If premature termination of 1 agent occurs due to toxicity, the other agent may be continued to complete up to 6 cycles of therapy. For participants who have not progressed, maintenance therapy will begin with infusions of sacituzumab govitecan-hziy 10 mg/kg on Days 1 and 8 every 21 days and zimberelimab 360 mg every 3 weeks (Day 1 of a 21-day cycle).
Sacituzumab Govitecan-hziy
Administered intravenously.
Cisplatin
Administered per package insert
Zimberelimab
Administered intravenously
Cohort 5 (Arm 1): SG + ZIM
Participants in Cohort 5 will have completed 4 to 6 cycles of gemcitabine (GEM) + cisplatin therapy without PD prior to study entry. The safety lead-in will be conducted, in 6 to 8 participants (treated with SG 10 mg/kg IV on Day 1 and Day 8 of a 21-day cycle + ZIM 360 mg IV every 3 weeks on a 21-day cycle). Upon completion of the safety lead-in, participants will receive SG 10 mg/kg IV on Days 1 and 8 of a 21-day cycle followed by ZIM 360 mg IV, every 3 weeks (Q3W) (Day 1 of a 21-day cycle) until PD, unacceptable toxicity, or loss of clinical benefit. participants who must discontinue 1 agent may continue the other until PD, unacceptable toxicity, or loss of clinical benefit.
Sacituzumab Govitecan-hziy
Administered intravenously.
Zimberelimab
Administered intravenously
Cohort 5 (Arm 2): Avelumab
Participants in Cohort 5 will have completed 4 to 6 cycles of gemcitabine (GEM) + cisplatin therapy without PD prior to study entry. The safety lead-in will be conducted, in 6 to 8 participants (treated with SG 10 mg/kg IV on Day 1 and Day 8 of a 21-day cycle + ZIM 360 mg IV every 3 weeks on a 21-day cycle). Upon completion of the safety lead-in, participants will be randomized to receive avelumab 800 mg IV every 2 weeks (Q2W) until PD, unacceptable toxicity, or loss of clinical benefit.
Avelumab
Administered per package insert
Cohort 5 (Arm 3): ZIM
Participants in Cohort 5 will have completed 4 to 6 cycles of gemcitabine (GEM) + cisplatin therapy without PD prior to study entry. The safety lead-in will be conducted, in 6 to 8 participants (treated with SG 10 mg/kg IV on Day 1 and Day 8 of a 21-day cycle + ZIM 360 mg IV every 3 weeks on a 21-day cycle).
Upon completion of the safety lead-in, participants will be randomized to receive ZIM 360 mg IV Q3W (Day
1 of a 21-day cycle) until PD, unacceptable toxicity, or loss of clinical benefit.
Zimberelimab
Administered intravenously
Cohort 6 (Arm 1): SG
Upon completion of the safety lead-in, participants in Cohort 6 will be randomized and SG will be administered in cisplatin-ineligible participants who have never received therapy in the metastatic setting or for unresectable locally advanced disease. Treatment may be discontinued at any time, but participants will continue to be followed for tumor response until progression is documented, and alternate therapy is initiated. If participants discontinue therapy before evidence of radiologic progression, imaging should continue until radiologic progression is documented, if feasible.
Sacituzumab Govitecan-hziy
Administered intravenously.
Cohort 6 (Arm 2): SG + ZIM
Upon completion of the safety lead-in, participants in Cohort 6 will be randomized and SG in combination with ZIM will be administered in cisplatin-ineligible participants who have never received therapy in the metastatic setting or for unresectable locally advanced disease. The standard approved dose of SG will be used in combination with ZIM. Treatment may be discontinued at any time, but participants will continue to be followed for tumor response until progression is documented or alternate therapy is initiated. If participants discontinue therapy before evidence of radiologic progression, imaging should continue until radiologic progression is documented, if feasible.
Sacituzumab Govitecan-hziy
Administered intravenously.
Zimberelimab
Administered intravenously
Cohort 6 (Arm 3): SG + ZIM + Domvanalimab (DOM)
Upon completion of the safety lead-in, participants in Cohort 6 will be randomized and SG in combination with ZIM and DOM will be administered in cisplatin-ineligible participants who have never received therapy in the metastatic setting or for unresectable locally advanced disease.
Sacituzumab Govitecan-hziy
Administered intravenously.
Zimberelimab
Administered intravenously
Domvanalimab
Administered intravenously
Cohort 6 (Arm 4): Carboplatin (CARBO) + Gemcitabine (GEM)
Upon completion of the safety lead-in, participants in Cohort 6 will be randomized and CARBO in combination with GEM will be administered in cisplatin-ineligible participants who have never received therapy in the metastatic setting or for unresectable locally advanced disease. Participants without disease progression as assessed by the investigator after completion of 4 to 6 cycles of therapy may continue with maintenance therapy (avelumab 800 mg every 2 weeks) until loss of clinical benefit.
Avelumab
Administered per package insert
Carboplatin
Administered per package insert
Gemcitabine
Administered per package insert
Cohort 7 (Phase 1: Safety Lad-in and Dose Expansion): SG + Enfortumab Vedotin (EV) + ZIM
In the safety lead-in phase, participants will receive a starting dose level of SG 7.5 mg/kg IV and starting dose level of EV 1.25 mg/kg IV will be administered on Days 1 and 8 of each 21-day cycle and ZIM 360 mg IV will be administered on Day 1 of each 21-day cycle.
In dose-expansion, participants will receive SG IV and EV IV at the RP2Ds on Days 1 and 8 of each 21-day cycle and ZIM 360 mg IV on Day 1 of each 21-day cycle.
Sacituzumab Govitecan-hziy
Administered intravenously.
Zimberelimab
Administered intravenously
Enfortumab Vedotin
Administered intravenously
Cohort 7 (Phase 2: Arm 1): SG + EV + ZIM
Upon completion of the Cohort 7 dose-expansion phase, participants will receive SG IV at the RP2D in combination with EV IV at the RP2D, and ZIM 360 mg IV until PD, unacceptable toxicity, or loss of clinical benefit.
Sacituzumab Govitecan-hziy
Administered intravenously.
Zimberelimab
Administered intravenously
Enfortumab Vedotin
Administered intravenously
Cohort 7 (Phase 2: Arm 2): EV + ZIM
Upon completion of the Cohort 7 dose-expansion phase, participants will receive EV 1.25 mg/kg IV and ZIM 360 mg IV.
Zimberelimab
Administered intravenously
Enfortumab Vedotin
Administered intravenously
Cohort 7 (Phase 2: Arm 3): Optional Dose Optimization SG + EV + ZIM
Upon completion of the Cohort 7 dose-expansion phase, participants will receive SG IV at 1 dose level below the RP2D in combination with EV 1.25 mg/kg IV and ZIM 360 mg IV.
Sacituzumab Govitecan-hziy
Administered intravenously.
Zimberelimab
Administered intravenously
Enfortumab Vedotin
Administered intravenously
Interventions
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Sacituzumab Govitecan-hziy
Administered intravenously.
Pembrolizumab
Administered per package insert
Cisplatin
Administered per package insert
Avelumab
Administered per package insert
Zimberelimab
Administered intravenously
Carboplatin
Administered per package insert
Gemcitabine
Administered per package insert
Domvanalimab
Administered intravenously
Enfortumab Vedotin
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1.
* Adequate renal and hepatic function.
* Adequate hematologic parameters without transfusional support.
* Individuals must have a 3-month life expectancy.
* Cohort 1: Have had progression or recurrence of urothelial cancer following receipt of platinum-containing regimen (cisplatin or carboplatin):
1. Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease;
2. Or received neo/adjuvant platinum-containing therapy for localized muscle-invasive urothelial cancer, with recurrence/progression ≤12 months following completion of therapy.
* Cohort 1: In addition to above criterion, have had progression or recurrence of urothelial cancer following receipt of an Anti-programmed Cell Death Protein 1 (anti-PD-1)/ Anti-programmed Death Ligand 1 (PD-L1) therapy.
* Cohort 2: Were ineligible for platinum-based therapy for first line metastatic disease and have had progression or recurrence of urothelial cancer after a first-line therapy for metastatic disease with anti-PD-1/PD-L1 therapy. Individual may not have received any platinum for treatment of recurrent, metastatic or advanced disease.
* Cohort 3: Progression or recurrence of UC following a platinum containing regimen in the metastatic setting, or progression or recurrence of UC within 12 months of completion of platinum-based therapy as neoadjuvant or adjuvant therapy.
* Cohort 4: Individual has not received any platinum-based chemotherapy in the metastatic or unresectable locally advanced setting. Creatinine clearance of at least 50 mL/min calculated by Cockcroft-Gault formula or another validated tool. For individuals receiving cisplatin at 70 mg/m\^2 on Day 1 of every 21-day cycle, a creatinine clearance of least 60 mL/min calculated by Cockcroft -Gault formula or another validated tool is required. Individuals with creatinine clearance between 50 to 59 mL/min are to receive a split dose of cisplatin (35 mg/m\^2 Day 1 and Day 8 of every 21-day cycle).
* Cohorts 4, 5, 6: Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma.
* Cohort 5: Individuals received at least 4 cycles and no more than 6 cycles of GEM + cisplatin. No other chemotherapy regimens are allowed in this cohort, with the exception of prior adjuvant or neoadjuvant systemic therapy with curative intent after \> 12 months from completion of therapy.
* No evidence of progressive disease following completion of first-line chemotherapy (ie, CR, PR, or SD per RECIST v1.1 guidelines as per investigator).
* Treatment-free interval of 4 to 10 weeks since the last dose of chemotherapy.
* Cohort 6: Cis-ineligible and no prior therapy for metastatic disease or for unresectable locally advanced disease. Checkpoint inhibitor therapy naïve or \>12 months from completion of adjuvant therapy are permitted.
* Cohorts 4 and 6: Have measurable disease by CT or MRI as per RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
* Cohorts 1, 2, 3 and 5: Creatinine clearance ≥ 30 mL/min as calculated by the Cockcroft-Gault formula unless otherwise specified
* No prior systemic therapy for locally advanced or metastatic UC. Therapy in the curative setting is allowed provided recurrence is \> 12 months since the last dose of systemic therapy.
* Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma.
* Have measurable disease by CT or MRI as per RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Exclusion Criteria
* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
* Has an active second malignancy.
* Has known active Hepatitis B or Hepatitis C.
* Has other concurrent medical or psychiatric conditions.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has an active second malignancy.
* For Cohort 5: Alopecia, sensory neuropathy Grade ≤2 is acceptable, or other Grade \<\< 2 adverse events not constituting a safety risk based on the investigator's judgment are acceptable.
* Cohort 3: Has received anti-PD-1/PD-L1 therapy previously.
* Cohorts 3 to 6: Has an active autoimmune disease that required systemic treatment in past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
* Cohorts 3 to 6: Has received a live vaccine within 30 days prior to the first dose of study drug(s), has history or evidence of interstitial lung disease (ILD) or non-infectious pneumonitis.
* Cohort 4: Refractory to platinum (i.e., relapsed ≤ 12 months after completion of chemotherapy) in the neoadjuvant/adjuvant setting.
* Cohorts 4, 5, and 6: For individuals who received prior CPI, a treatment-free interval \>12 months between the last treatment administration and the date of recurrence is required.
* Have had a prior anticancer therapy within 12 months prior to C1D1 or prior radiation therapy within 2 weeks prior to C1D1. Individuals participating in observational studies are eligible. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of investigational product.
* Have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
* Have a Child-Pugh score of B or C.
* Individuals with uncontrolled diabetes.
* Have active keratitis or corneal ulcerations.
* Participants with ongoing sensory or motor neuropathy Grade ≥ 2.
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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The University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Rocky Mountain Cancer Centers
Littleton, Colorado, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Woodlands Medical Specialists, PA
Pensacola, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Southern Illinois University School of Medicine, Simmons Cancer Institute
Springfield, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Norton Cancer Institute, Downtown
Louisville, Kentucky, United States
Maryland Oncology Hematology, P.A.
Brandywine, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Precision Cancer Research / New Mexico Oncology & Hematology Consultants
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Drug Shipping Address: New York-Presbyterian Hospital
New York, New York, United States
Stony Brook Cancer Center
Stony Brook, New York, United States
St. Luke's Hosptial - Bethlehem Campus
Easton, Pennsylvania, United States
Medical University of Southern Carolina
Charleston, South Carolina, United States
Thompson Oncology Group - Knoxville West
Knoxville, Tennessee, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
Houston Methodist Hospital, Houston Methodist Cancer Center
Houston, Texas, United States
Mays Cancer Center
San Antonio, Texas, United States
Renovatio Clinical
The Woodlands, Texas, United States
University of Utah - Huntsman Cancer Hospital (IP Shipping Address)
Salt Lake City, Utah, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Virginia Oncology Associates
Hampton, Virginia, United States
Oncology Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States
Centre Hospitalier Regional Universitaire (CHRU) de Besancon, Hopital Jean Minjoz
Besançon, , France
Hopital Saint Andre (CHU de Bordeaux)
Bordeaux, , France
Centre Hospitalier Regional Universitaire Brest
Brest, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre Hospitalier Departmental (CHD) Vendee
La Roche-sur-Yon, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Centre Antoine Lacassagne
Nice, , France
Centre Hospitalier Universitaire De Nimes - Hopital Universitaire Caremeau
Nîmes, , France
Hopital European Georges-Pompidou (HEGP)
Paris, , France
Groupement Hospitalier Pitie-Salpetriere
Paris, , France
Hopital Cochin
Paris, , France
Centre Hospitalier Prive Saint-Gregoire
Rennes, , France
Centre Eugene Marquis
Rennes, , France
CHU de Rouen
Rouen, , France
Hospitaux Universitaires de Strasbourg - Hopital Civil
Strasbourg, , France
Hospital Foch
Suresnes, , France
Institut Claudius Regaud
Toulouse, , France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Urologicum Duisburg
Duisburg, , Germany
Centrum fur Hamatologie und Onkologie Bethanien
Frankfurt, , Germany
Universitätsklinikum Frankfurt, Klinik für Urologie
Frankfurt, , Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, , Germany
University Hospital Heidelberg
Heidelberg, , Germany
Marien Hospital Herne
Herne, , Germany
Universitatsklinikum Jena
Jena, , Germany
Institut für Versorgungsforschung in der Onkologie
Koblenz, , Germany
Universitätsklinikum Magdeburg
Magdeburg, , Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Mainz, , Germany
Klinikum rechts der Isar der Technischen Universität München, Urologische Klinik und Poloklinik
München, , Germany
Universitatsklinikum Munster, Klinik fur Urologie und Kinderurologie
Münster, , Germany
Universitat Regensburg
Regensburg, , Germany
Universitatsklinikum Tubingen, Klinik fur Urologie
Tübingen, , Germany
Henry Dunant Hospital Center, 4th Oncology Department
Athens, , Greece
University General Hospital of Ioannina, Oncology Department
Ioannina, , Greece
Athens Medical Center, Oncology Department
Marousi, , Greece
General Hospital of Patras Agios Andreas
Pátrai, , Greece
Anassa General Clinic, Oncology-Chemotherapy Department
Volos, , Greece
Ospedale San Donato
Arezzo, , Italy
Centro di Riferimento Oncologico IRCCS
Aviano, , Italy
ASST Cremona
Cremona, , Italy
Ospedale Policlinico San Martino IRCCS
Genoa, , Italy
Istituto Romagnolo per Io Studio dei Tumori (IRST) "Dino Amadori"
Meldola, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Azienda Ospedaliero Universitaria Maggiore della Carita
Novara, , Italy
Istituto Oncologico Veneto IRCCS - Ospedale Busonera
Padua, , Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, , Italy
Instituto Nazionale Tumori Regina Elena - IFO
Roma, , Italy
Azienda Ospedaliera Santa Maria di Temi
Terni, , Italy
Centro Ricerche Cliniche di Verona srl
Verona, , Italy
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
National Cancer Center
Goyang-si, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Korea University - Anam Hospital
Seongbuk-Gu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei University Health System, Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, , South Korea
Yonsei University - Wonju Severance Christian Hospital
Wŏnju, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Institut Catala d'Oncologia Badalona - Hospital Universitari Germans Trias i Pujol
Badalona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
CEIC Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas, , Spain
MD Anderson Cancer Centre
Madrid, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puera de Hierro Majadahonda
Majadahonda, , Spain
Hospital Sant Joan de Deu
Manresa, , Spain
Complejo Hospitalario de Ourense
Ourense, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Ankara Sehir Hastanesi
Ankara, , Turkey (Türkiye)
Dicle Universitesi Tip Fakultesi Hastanesi
Diyarbakır, , Turkey (Türkiye)
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
Edrine, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi Hastanesi
Istanbul, , Turkey (Türkiye)
Medipol Mega Universite Hastanesi
Istanbul, , Turkey (Türkiye)
T.C. Saglik Bakanligi Goztepe Prof Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, , Turkey (Türkiye)
Izmir Medical Point Hastanesi, Medikal Onkoloji Departmant
Izmir, , Turkey (Türkiye)
Baskent Universitesi Adana Dr.Turgut Noyan Uygulama ve Arastima Merkezi
Seyhan, , Turkey (Türkiye)
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
East and North Hertfordshire NHS Trust
Northwood, , United Kingdom
The Royal Marsden NHS Foundation Trust
Surrey, , United Kingdom
Countries
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Central Contacts
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References
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Petrylak DP, Tagawa ST, Jain RK, Bupathi M, Balar A, Kalebasty AR, George S, Palmbos P, Nordquist L, Davis N, Ramamurthy C, Sternberg CN, Loriot Y, Agarwal N, Park C, Tonelli J, Vance M, Zhou H, Grivas P. TROPHY-U-01 Cohort 2: A Phase II Study of Sacituzumab Govitecan in Cisplatin-Ineligible Patients With Metastatic Urothelial Cancer Progressing After Previous Checkpoint Inhibitor Therapy. J Clin Oncol. 2024 Oct 10;42(29):3410-3420. doi: 10.1200/JCO.23.01720. Epub 2024 Aug 26.
Loriot Y, Kalebasty AR, Flechon A, Jain RK, Gupta S, Bupathi M, Beuzeboc P, Palmbos P, Balar AV, Kyriakopoulos CE, Pouessel D, Sternberg CN, Tonelli J, Sierecki M, Zhou H, Grivas P, Barthelemy P, Bangs R, Tagawa ST. A plain language summary of the TROPHY-U-01 study: sacituzumab govitecan use in people with locally advanced or metastatic urothelial cancer. Future Oncol. 2024;20(23):1621-1631. doi: 10.2217/fon-2023-1030. Epub 2024 Jun 5.
Grivas P, Pouessel D, Park CH, Barthelemy P, Bupathi M, Petrylak DP, Agarwal N, Gupta S, Flechon A, Ramamurthy C, Davis NB, Recio-Boiles A, Sternberg CN, Bhatia A, Pichardo C, Sierecki M, Tonelli J, Zhou H, Tagawa ST, Loriot Y. Sacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3. J Clin Oncol. 2024 Apr 20;42(12):1415-1425. doi: 10.1200/JCO.22.02835. Epub 2024 Jan 23.
Tagawa ST, Balar AV, Petrylak DP, Kalebasty AR, Loriot Y, Flechon A, Jain RK, Agarwal N, Bupathi M, Barthelemy P, Beuzeboc P, Palmbos P, Kyriakopoulos CE, Pouessel D, Sternberg CN, Hong Q, Goswami T, Itri LM, Grivas P. TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors. J Clin Oncol. 2021 Aug 1;39(22):2474-2485. doi: 10.1200/JCO.20.03489. Epub 2021 Apr 30.
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2023-508302-24
Identifier Type: OTHER
Identifier Source: secondary_id
IMMU-132-06
Identifier Type: -
Identifier Source: org_study_id
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