Active, not recruitingNCT03547973TROPHY U-01Updated Sep 1, 2026

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

A Phase 2 interventional study of Sacituzumab Govitecan-hziy and Pembrolizumab in Metastatic Urothelial Cancer, sponsored by Gilead Sciences. Active, not recruiting at 128 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 502
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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 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.

Conditions studied

Metastatic Urothelial Cancer

In context

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Key Inclusion Criteria:

Inclusion criteria

Inclusion Criteria for All Cohorts:

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:

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

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.

Key Exclusion Criteria:

Exclusion criteria

Exclusion Criteria for All cohorts:

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.
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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 502 participants (actual)

Study arms

Experimental
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.
Drug: Sacituzumab Govitecan-hziy
Experimental
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.
Drug: Sacituzumab Govitecan-hziy
Experimental
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.
Drug: Sacituzumab Govitecan-hziy · Drug: Pembrolizumab
Experimental
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.
Drug: Sacituzumab Govitecan-hziy · Drug: Cisplatin · Drug: Avelumab
Experimental
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).
Drug: Sacituzumab Govitecan-hziy · Drug: Cisplatin · Drug: Zimberelimab
Experimental
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.
Drug: Sacituzumab Govitecan-hziy · Drug: Zimberelimab
Experimental
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.
Drug: Avelumab
Experimental
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.
Drug: Zimberelimab
Experimental
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.
Drug: Sacituzumab Govitecan-hziy
Experimental
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.
Drug: Sacituzumab Govitecan-hziy · Drug: Zimberelimab
Experimental
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.
Drug: Sacituzumab Govitecan-hziy · Drug: Zimberelimab · Drug: Domvanalimab
Experimental
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.
Drug: Avelumab · Drug: Carboplatin · Drug: Gemcitabine
Experimental
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.
Drug: Sacituzumab Govitecan-hziy · Drug: Zimberelimab · Drug: Enfortumab Vedotin
Experimental
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.
Drug: Sacituzumab Govitecan-hziy · Drug: Zimberelimab · Drug: Enfortumab Vedotin
Experimental
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.
Drug: Zimberelimab · Drug: Enfortumab Vedotin
Experimental
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.
Drug: Sacituzumab Govitecan-hziy · Drug: Zimberelimab · Drug: Enfortumab Vedotin

Interventions

DrugSacituzumab Govitecan-hziy
Administered intravenously.
Also known as: IMMU-132, Trodelvy™
DrugPembrolizumab
Administered per package insert
Also known as: KEYTRUDA®
DrugCisplatin
Administered per package insert
DrugAvelumab
Administered per package insert
Also known as: BAVENCIO®
DrugZimberelimab
Administered intravenously
DrugCarboplatin
Administered per package insert
DrugGemcitabine
Administered per package insert
DrugDomvanalimab
Administered intravenously
DrugEnfortumab Vedotin
Administered intravenously

What researchers measure

Primary outcomes

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.
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
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.
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
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.
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) (Cohort 7)
Time frame: First dose date up to last dose date plus 30 days (approximately 3 years)
Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities (Cohort 7)
Time frame: First dose date up to last dose date plus 30 days (approximately 3 years)

Secondary outcomes

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.
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
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.
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
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.
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
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.
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
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.
Time frame: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) (Cohorts 3, 4, 5, and 6)
Time frame: First dose date up to last dose date plus 30 days (approximately 3 years)
Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities (Cohorts 3, 4, 5, and 6)
Time frame: First dose date up to last dose date plus 30 days (approximately 3 years)

Study locations

128 sites

The University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719, United States
University of California San Francisco
San Francisco, California 94158, United States
Rocky Mountain Cancer Centers
Littleton, Colorado 80120, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut 06510, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140, United States
Woodlands Medical Specialists, PA
Pensacola, Florida 32503, United States
Moffitt Cancer Center
Tampa, Florida 33612, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia 30322, United States
University of Illinois Cancer Center
Chicago, Illinois 60612, United States
University of Chicago Medical Center
Chicago, Illinois 60637, United States
Southern Illinois University School of Medicine, Simmons Cancer Institute
Springfield, Illinois 62702, United States
Norton Cancer Institute, Downtown
Louisville, Kentucky 40202, United States
University of Michigan
Ann Arbor, Michigan 48109, United States
Karmanos Cancer Institute
Detroit, Michigan 48201, United States
Precision Cancer Research / New Mexico Oncology & Hematology Consultants
Albuquerque, New Mexico 87109, United States
Roswell Park Cancer Institute
Buffalo, New York 14263, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016, United States
Drug Shipping Address: New York-Presbyterian Hospital
New York, New York 10065, United States
Stony Brook Cancer Center
Stony Brook, New York 11794, United States
St. Luke's Hosptial - Bethlehem Campus
Easton, Pennsylvania 18045, United States
Medical University of Southern Carolina
Charleston, South Carolina 29425, United States
Thompson Oncology Group - Knoxville West
Knoxville, Tennessee 37932, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee 37232, United States
Houston Methodist Hospital, Houston Methodist Cancer Center
Houston, Texas 77030, United States
Mays Cancer Center
San Antonio, Texas 78229, United States
University of Utah - Huntsman Cancer Hospital (IP Shipping Address)
Salt Lake City, Utah 84112, United States
Virginia Oncology Associates
Hampton, Virginia 23666, United States
Oncology Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia 24014, United States
Seattle Cancer Care Alliance
Seattle, Washington 98109, United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin 53705, United States
Centre Hospitalier Regional Universitaire (CHRU) de Besancon, Hopital Jean Minjoz
Besançon, 25000, France
Hopital Saint Andre (CHU de Bordeaux)
Bordeaux, 33000, France
Centre Hospitalier Regional Universitaire Brest
Brest, 29200, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre Hospitalier Departmental (CHD) Vendee
La Roche-sur-Yon, 85925, France
Centre Oscar Lambret
Lille, 59000, France
Centre Leon Berard
Lyon, 69373, France
Institut Paoli Calmettes
Marseille, 13273, France
Centre Antoine Lacassagne
Nice, 06189, France
Centre Hospitalier Universitaire De Nimes - Hopital Universitaire Caremeau
Nîmes, 30029, France
Hopital European Georges-Pompidou (HEGP)
Paris, 33000, France
Groupement Hospitalier Pitie-Salpetriere
Paris, 75013, France
Hopital Cochin
Paris, 75014, France
Centre Hospitalier Prive Saint-Gregoire
Rennes, 35000, France
Centre Eugene Marquis
Rennes, 35042, France
CHU de Rouen
Rouen, 76031, France
Hospitaux Universitaires de Strasbourg - Hopital Civil
Strasbourg, 67200, France
Hospital Foch
Suresnes, 92150, France
Institut Claudius Regaud
Toulouse, 31059, France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
Institut Gustave Roussy
Villejuif, 94800, France
Urologicum Duisburg
Duisburg, 47179, Germany
Centrum fur Hamatologie und Onkologie Bethanien
Frankfurt, 60389, Germany
Universitätsklinikum Frankfurt, Klinik für Urologie
Frankfurt, 60590, Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
University Hospital Heidelberg
Heidelberg, 69120, Germany
Marien Hospital Herne
Herne, 44625, Germany
Universitatsklinikum Jena
Jena, 07743, Germany
Institut für Versorgungsforschung in der Onkologie
Koblenz, 56068, Germany
Universitätsklinikum Magdeburg
Magdeburg, 39120, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Mainz, 55131, Germany
Klinikum rechts der Isar der Technischen Universität München, Urologische Klinik und Poloklinik
München, 81675, Germany
Universitatsklinikum Munster, Klinik fur Urologie und Kinderurologie
Münster, 48149, Germany
Universitat Regensburg
Regensburg, 93053, Germany
Universitatsklinikum Tubingen, Klinik fur Urologie
Tübingen, 72076, Germany
Henry Dunant Hospital Center, 4th Oncology Department
Athens, 11526, Greece
University General Hospital of Ioannina, Oncology Department
Ioannina, 45500, Greece
Athens Medical Center, Oncology Department
Marousi, 15125, Greece
General Hospital of Patras Agios Andreas
Pátrai, 26335, Greece
Anassa General Clinic, Oncology-Chemotherapy Department
Volos, 38333, Greece
Ospedale San Donato
Arezzo, 52100, Italy
Centro di Riferimento Oncologico IRCCS
Aviano, 33081, Italy
ASST Cremona
Cremona, 26100, Italy
Ospedale Policlinico San Martino IRCCS
Genoa, 16132, Italy
Istituto Romagnolo per Io Studio dei Tumori (IRST) "Dino Amadori"
Meldola, 47014, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
IRCCS Ospedale San Raffaele
Milan, 20133, Italy
Azienda Ospedaliero Universitaria Maggiore della Carita
Novara, 28100, Italy
Istituto Oncologico Veneto IRCCS - Ospedale Busonera
Padova, 35128, Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, 56126, Italy
Instituto Nazionale Tumori Regina Elena - IFO
Roma, 00144, Italy
Azienda Ospedaliera Santa Maria di Temi
Terni, 05100, Italy
Centro Ricerche Cliniche di Verona srl
Verona, 37126, Italy
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
Chonnam National University Hwasun Hospital
Hwasun, 519-763, South Korea
Korea University - Anam Hospital
Seongbuk-Gu, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Yonsei University Health System, Severance Hospital
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
SMG-SNU Boramae Medical Center
Seoul, 07061, South Korea
Asan Medical Center
Seoul, 5505, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, 16247, South Korea
Yonsei University - Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Pusan National University Yangsan Hospital
Yangsan, 50612, South Korea
Institut Catala d'Oncologia Badalona - Hospital Universitari Germans Trias i Pujol
Badalona, 08916, Spain
Hospital del Mar
Barcelona, 08003, Spain

Showing the first 100 of 128 sites across 9 countries.

References and documents

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 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03547973
Lead sponsor: Gilead Sciences
Collaborators: Merck KGaA, Darmstadt, Germany
Responsible party: Sponsor
First posted: Jun 6, 2018
Start date: Aug 13, 2018
Primary completion: Apr 2030 (estimated)
Completion: Apr 2030 (estimated)
Last update: Sep 1, 2026

Study contacts

Gilead Study Director

study director · Gilead Sciences

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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