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AzTrials

Metastatic Urothelial CancerPhase 2TROPHY U-01NCT03547973

Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread

A Phase 2 study testing Sacituzumab Govitecan-hziy, Pembrolizumab and Cisplatin in people with Metastatic Urothelial Cancer, run by Gilead Sciences at 128 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Urothelial Cancer
What is being tested?
Sacituzumab Govitecan-hziy, Pembrolizumab and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
502 participants
Where
128 sitesin 9 countries
Study dates
13 Aug 2018to Apr 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female or male individuals, ≥ 18 years of age (19 Years old for South Korea).
  • 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.
  • Additional Inclusion Criteria for Cohorts 1 to 6:
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  • Cohort 1: Have had progression or recurrence of urothelial cancer following receipt of platinum-containing regimen (cisplatin or carboplatin):
  • Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease;
  • 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
  • Additional Inclusion Criteria for Cohort 7:
  • 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.

Who cannot join

  • Females who are pregnant or lactating.
  • 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.
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  • Has an active second malignancy.
  • Additional Exclusion Criteria for Cohorts 1 to 6:
  • 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.
  • Additional Exclusion Criteria for Cohort 7:
  • 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.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

128 sites in 9 countries.

128 sites in 9 countries

United States30 sites

  • Precision Cancer Research / New Mexico Oncology & Hematology Consultants

    Albuquerque, New Mexico, 87109

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Medical University of Southern Carolina

    Charleston, South Carolina, 29425

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • St. Luke's Hosptial - Bethlehem Campus

    Easton, Pennsylvania, 18045

  • Virginia Oncology Associates

    Hampton, Virginia, 23666

  • Houston Methodist Hospital, Houston Methodist Cancer Center

    Houston, Texas, 77030

  • Thompson Oncology Group - Knoxville West

    Knoxville, Tennessee, 37932

  • Rocky Mountain Cancer Centers

    Littleton, Colorado, 80120

  • Norton Cancer Institute, Downtown

    Louisville, Kentucky, 40202

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin, 53705

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232

  • Smilow Cancer Hospital at Yale-New Haven

    New Haven, Connecticut, 06510

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

  • Drug Shipping Address: New York-Presbyterian Hospital

    New York, New York, 10065

  • Woodlands Medical Specialists, PA

    Pensacola, Florida, 32503

  • Oncology Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • University of Utah - Huntsman Cancer Hospital (IP Shipping Address)

    Salt Lake City, Utah, 84112

  • Mays Cancer Center

    San Antonio, Texas, 78229

  • University of California San Francisco

    San Francisco, California, 94158

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Southern Illinois University School of Medicine, Simmons Cancer Institute

    Springfield, Illinois, 62702

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • The University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

Other trials in United States

France21 sites

  • Centre Hospitalier Regional Universitaire (CHRU) de Besancon, Hopital Jean Minjoz

    Besançon, 25000

  • Hopital Saint Andre (CHU de Bordeaux)

    Bordeaux, 33000

  • Centre Hospitalier Regional Universitaire Brest

    Brest, 29200

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Hospitalier Departmental (CHD) Vendee

    La Roche-sur-Yon, 85925

  • Centre Oscar Lambret

    Lille, 59000

  • Centre Leon Berard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, 13273

  • Centre Antoine Lacassagne

    Nice, 06189

  • Centre Hospitalier Universitaire De Nimes - Hopital Universitaire Caremeau

    Nîmes, 30029

  • Hopital European Georges-Pompidou (HEGP)

    Paris, 33000

  • Groupement Hospitalier Pitie-Salpetriere

    Paris, 75013

  • Hopital Cochin

    Paris, 75014

  • Centre Hospitalier Prive Saint-Gregoire

    Rennes, 35000

  • Centre Eugene Marquis

    Rennes, 35042

  • CHU de Rouen

    Rouen, 76031

  • Hospitaux Universitaires de Strasbourg - Hopital Civil

    Strasbourg, 67200

  • Hospital Foch

    Suresnes, 92150

  • Institut Claudius Regaud

    Toulouse, 31059

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

Spain18 sites

  • Institut Catala d'Oncologia Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Clinic de Barcelona

    Barcelona, 08023

  • CEIC Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Complejo Hospitalario Universitario Insular Materno Infantil

    Las Palmas, 35016

  • MD Anderson Cancer Centre

    Madrid, 28033

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puera de Hierro Majadahonda

    Majadahonda, 28222

  • Hospital Sant Joan de Deu

    Manresa, 08243

  • Complejo Hospitalario de Ourense

    Ourense, 32005

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, 15706

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Germany15 sites

  • Urologicum Duisburg

    Duisburg, 47179

  • Centrum fur Hamatologie und Onkologie Bethanien

    Frankfurt, 60389

  • Universitätsklinikum Frankfurt, Klinik für Urologie

    Frankfurt, 60590

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • University Hospital Heidelberg

    Heidelberg, 69120

  • Marien Hospital Herne

    Herne, 44625

  • Universitatsklinikum Jena

    Jena, 07743

  • Institut für Versorgungsforschung in der Onkologie

    Koblenz, 56068

  • Universitätsklinikum Magdeburg

    Magdeburg, 39120

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Mainz, 55131

  • Klinikum rechts der Isar der Technischen Universität München, Urologische Klinik und Poloklinik

    München, 81675

  • Universitatsklinikum Munster, Klinik fur Urologie und Kinderurologie

    Münster, 48149

  • Universitat Regensburg

    Regensburg, 93053

  • Universitatsklinikum Tubingen, Klinik fur Urologie

    Tübingen, 72076

Other trials in Germany

South Korea14 sites

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Keimyung University Dongsan Hospital

    Daegu, 42601

  • National Cancer Center

    Goyang-si, 10408

  • Chonnam National University Hospital

    Gwangju, 61469

  • Chonnam National University Hwasun Hospital

    Hwasun, 519-763

  • Korea University - Anam Hospital

    Seongbuk-Gu

  • Seoul National University Hospital

    Seoul, 03080

  • Yonsei University Health System, Severance Hospital

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

  • SMG-SNU Boramae Medical Center

    Seoul, 07061

  • Asan Medical Center

    Seoul, 5505

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, 16247

  • Yonsei University - Wonju Severance Christian Hospital

    Wŏnju, 26426

  • Pusan National University Yangsan Hospital

    Yangsan, 50612

Other trials in South Korea

Italy13 sites

  • Ospedale San Donato

    Arezzo, 52100

  • Centro di Riferimento Oncologico IRCCS

    Aviano, 33081

  • ASST Cremona

    Cremona, 26100

  • Ospedale Policlinico San Martino IRCCS

    Genoa, 16132

  • Istituto Romagnolo per Io Studio dei Tumori (IRST) "Dino Amadori"

    Meldola, 47014

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • IRCCS Ospedale San Raffaele

    Milan, 20133

  • Azienda Ospedaliero Universitaria Maggiore della Carita

    Novara, 28100

  • Istituto Oncologico Veneto IRCCS - Ospedale Busonera

    Padova, 35128

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126

  • Instituto Nazionale Tumori Regina Elena - IFO

    Roma, 00144

  • Azienda Ospedaliera Santa Maria di Temi

    Terni, 05100

  • Centro Ricerche Cliniche di Verona srl

    Verona, 37126

Other trials in Italy

Turkey (Türkiye)8 sites

  • Ankara Sehir Hastanesi

    Ankara, 06550

  • Dicle Universitesi Tip Fakultesi Hastanesi

    Diyarbakır, 21280

  • Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

    Edrine, 22030

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi Hastanesi

    Istanbul, 34098

  • Medipol Mega Universite Hastanesi

    Istanbul, 34214

  • T.C. Saglik Bakanligi Goztepe Prof Dr. Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722

  • Izmir Medical Point Hastanesi, Medikal Onkoloji Departmant

    Izmir, 35575

  • Baskent Universitesi Adana Dr.Turgut Noyan Uygulama ve Arastima Merkezi

    Seyhan, 01250

Other trials in Turkey (Türkiye)

Greece5 sites

  • Henry Dunant Hospital Center, 4th Oncology Department

    Athens, 11526

  • University General Hospital of Ioannina, Oncology Department

    Ioannina, 45500

  • Athens Medical Center, Oncology Department

    Marousi, 15125

  • General Hospital of Patras Agios Andreas

    Pátrai, 26335

  • Anassa General Clinic, Oncology-Chemotherapy Department

    Volos, 38333

Other trials in Greece

United Kingdom4 sites

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B9 5SS

  • Barts Health NHS Trust

    London, E1 1BB

  • East and North Hertfordshire NHS Trust

    Northwood, HA6 2JW

  • The Royal Marsden NHS Foundation Trust

    Surrey, SM2 5PT

Other trials in United Kingdom

About this study

Official title: A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer

The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).

Read the detailed description

Non-Randomized for Cohorts 1,2,3, and 4; Randomized for Cohorts 5, 6, and 7. Cohort 5 has been cancelled, effective December 2023.

Being tested
Sacituzumab Govitecan-hziy, Pembrolizumab, Cisplatin, Avelumab, Zimberelimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab Govitecan-hziyDrug

    Also called IMMU-132, Trodelvy™

    Administered intravenously.

  • PembrolizumabDrug

    Also called KEYTRUDA®

    Administered per package insert

  • CisplatinDrug

    Administered per package insert

  • AvelumabDrug

    Also called BAVENCIO®

    Administered per package insert

  • ZimberelimabDrug

    Administered intravenously

  • CarboplatinDrug

    Administered per package insert

  • GemcitabineDrug

    Administered per package insert

  • DomvanalimabDrug

    Administered intravenously

  • Enfortumab VedotinDrug

    Administered intravenously

Study groups in NCT03547973
Study groupRoleWhat they receive
Cohort 1: Sacituzumab Govitecan-hziy (SG)ExperimentalParticipants 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.
Receives: Drug: Sacituzumab Govitecan-hziy
Cohort 2: SGExperimentalParticipants 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.
Receives: Drug: Sacituzumab Govitecan-hziy
Cohort 3: SG + PembrolizumabExperimentalParticipants 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.
Receives: Drug: Sacituzumab Govitecan-hziy; Drug: Pembrolizumab
Cohort 4: SG + Cisplatin + Avelumab (Dose Escalation Phase)ExperimentalParticipants 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.
Receives: Drug: Sacituzumab Govitecan-hziy; Drug: Cisplatin; Drug: Avelumab
Cohort 4: SG + Cisplatin + Zimberelimab (ZIM) (Dose Expansion Phase)ExperimentalParticipants 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).
Receives: Drug: Sacituzumab Govitecan-hziy; Drug: Cisplatin; Drug: Zimberelimab
Cohort 5 (Arm 1): SG + ZIMExperimentalParticipants 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.
Receives: Drug: Sacituzumab Govitecan-hziy; Drug: Zimberelimab
Cohort 5 (Arm 2): AvelumabExperimentalParticipants 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.
Receives: Drug: Avelumab
Cohort 5 (Arm 3): ZIMExperimentalParticipants 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.
Receives: Drug: Zimberelimab
Cohort 6 (Arm 1): SGExperimentalUpon 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.
Receives: Drug: Sacituzumab Govitecan-hziy
Cohort 6 (Arm 2): SG + ZIMExperimentalUpon 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.
Receives: Drug: Sacituzumab Govitecan-hziy; Drug: Zimberelimab
Cohort 6 (Arm 3): SG + ZIM + Domvanalimab (DOM)ExperimentalUpon 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.
Receives: Drug: Sacituzumab Govitecan-hziy; Drug: Zimberelimab; Drug: Domvanalimab
Cohort 6 (Arm 4): Carboplatin (CARBO) + Gemcitabine (GEM)ExperimentalUpon 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.
Receives: Drug: Avelumab; Drug: Carboplatin; Drug: Gemcitabine
Cohort 7 (Phase 1: Safety Lad-in and Dose Expansion): SG + Enfortumab Vedotin (EV) + ZIMExperimentalIn 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.
Receives: Drug: Sacituzumab Govitecan-hziy; Drug: Zimberelimab; Drug: Enfortumab Vedotin
Cohort 7 (Phase 2: Arm 1): SG + EV + ZIMExperimentalUpon 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.
Receives: Drug: Sacituzumab Govitecan-hziy; Drug: Zimberelimab; Drug: Enfortumab Vedotin
Cohort 7 (Phase 2: Arm 2): EV + ZIMExperimentalUpon completion of the Cohort 7 dose-expansion phase, participants will receive EV 1.25 mg/kg IV and ZIM 360 mg IV.
Receives: Drug: Zimberelimab; Drug: Enfortumab Vedotin
Cohort 7 (Phase 2: Arm 3): Optional Dose Optimization SG + EV + ZIMExperimentalUpon 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.
Receives: Drug: Sacituzumab Govitecan-hziy; Drug: Zimberelimab; Drug: Enfortumab Vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR) Based on Central Review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria (Cohorts 1 to 4 and 6)

    ORR will be defined as the rate of the best overall response as Complete Response (CR) or Partial Response (PR) and based on central review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria.

    Measured: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))

  2. Progression free survival (PFS) Based on Central Review by RECIST 1.1 criteria (Cohort 5)

    PFS will be defined as the time from first dose until objective tumor progression, as assessed based on central review, or death, whichever comes first.

    Measured: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))

  3. ORR Based on Investigator Review by RECIST 1.1 Criteria (Cohort 7)

    ORR will be defined as the rate of the best overall response as Complete Response (CR) or Partial Response (PR) and based on investigator review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria.

    Measured: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))

  4. Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) (Cohort 7)

    Measured: First dose date up to last dose date plus 30 days (approximately 3 years)

  5. Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities (Cohort 7)

    Measured: First dose date up to last dose date plus 30 days (approximately 3 years)

Secondary outcomes (7)

  1. Overall Response Rate (ORR)

    ORR will be defined as the rate of the best overall response as CR or PR and based on investigator review by RECIST 1.1 criteria for cohorts 3, 4, 6, and 7. ORR will also be evaluated based on investigator review by Modified RECIST 1.1 for Immune-Based Therapeutics (iRECIST 1.1) for Cohorts 3, 4, 6, and 7.

    Measured: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))

  2. Duration of Response (DOR)

    DOR will be calculated from the date of the first evaluation showing documented response, PR, or CR, to the date of the first disease progression or death and based on central and investigator review by RECIST 1.1 criteria for all cohorts. DOR will also be evaluated based on investigator review by iRECIST 1.1 for Cohorts 3, 4, 6, and 7.

    Measured: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))

  3. Progression-Free Survival (PFS)

    PFS is defined as the time from the first dose (Cohorts 1 through 4) or randomization date (Cohorts 5 through 7) until objective tumor progression,or death, whichever comes first and based on central and investigator review by RECIST 1.1 criteria for all cohorts. PFS will also be evaluated based on investigator review by iRECIST 1.1 for Cohorts 3, 4, 6, and 7.

    Measured: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))

  4. Overall Survival (OS)

    OS will be measured from the date of first dose (Cohorts 1 through 4) or randomization date (Cohorts 5 through 7) to death from any cause.

    Measured: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))

  5. Clinical Benefit Rate (CBR)

    CBR is defined as CR + PR + Stable Disease (SD) for at least 6 months and based on central and investigator review by RECIST 1.1 criteria for Cohorts 3, 4, 6, and 7. CBR will also be evaluated based on investigator review by iRECIST 1.1 for Cohorts 3, 4, 6, and 7.

    Measured: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))

  6. Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) (Cohorts 3, 4, 5, and 6)

    Measured: First dose date up to last dose date plus 30 days (approximately 3 years)

  7. Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities (Cohorts 3, 4, 5, and 6)

    Measured: First dose date up to last dose date plus 30 days (approximately 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2018
  2. Study start13 Aug 2018
  3. Primary completionApr 2030 (estimated)
  4. Study completionApr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
502 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03547973
Sponsor's protocol ID
IMMU-132-06
Other IDs
2023-508302-24, 2023
Acronym
TROPHY U-01
Status last verified
Aug 2026
First submitted
26 Apr 2018
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39186707

  • 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.

    PubMed 38682560

  • 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.

    PubMed 38261969

  • 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.

    PubMed 33929895

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab Govitecan-hziy, Pembrolizumab and Cisplatin in people with Metastatic Urothelial Cancer, run by Gilead Sciences at 128 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 sites in United States, France, Spain, Germany, South Korea and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) Based on Central Review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria (Cohorts 1 to 4 and 6) (time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03547973, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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