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

NCT03547973 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IMMU-132-062023-508302-24
• Study Type: interventional
• Target: 827
• Locations: 9 countries
• Sites: 135

Brief 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).

Conditions

Metastatic Urothelial Cancer

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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)

  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)

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

Secondary Outcomes (7)

• Overall Response Rate (ORR)

  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)

  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)

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

• Overall Survival (OS)

  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)

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

Study Arms (16)

Cohort 1: Sacituzumab Govitecan-hziy (SG)

EXPERIMENTAL

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

Cohort 2: SG

EXPERIMENTAL

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

Cohort 3: SG + Pembrolizumab

EXPERIMENTAL

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

Cohort 4: SG + Cisplatin + Avelumab (Dose Escalation Phase)

EXPERIMENTAL

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

Cohort 4: SG + Cisplatin + Zimberelimab (ZIM) (Dose Expansion Phase)

EXPERIMENTAL

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

Cohort 5 (Arm 1): SG + ZIM

EXPERIMENTAL

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

Cohort 5 (Arm 2): Avelumab

EXPERIMENTAL

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

Cohort 5 (Arm 3): ZIM

EXPERIMENTAL

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

Cohort 6 (Arm 1): SG

EXPERIMENTAL

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

Cohort 6 (Arm 2): SG + ZIM

EXPERIMENTAL

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

Cohort 6 (Arm 3): SG + ZIM + Domvanalimab (DOM)

EXPERIMENTAL

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

Cohort 6 (Arm 4): Carboplatin (CARBO) + Gemcitabine (GEM)

EXPERIMENTAL

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

Cohort 7 (Phase 1: Safety Lad-in and Dose Expansion): SG + Enfortumab Vedotin (EV) + ZIM

EXPERIMENTAL

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

Cohort 7 (Phase 2: Arm 1): SG + EV + ZIM

EXPERIMENTAL

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

Cohort 7 (Phase 2: Arm 2): EV + ZIM

EXPERIMENTAL

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

Cohort 7 (Phase 2: Arm 3): Optional Dose Optimization SG + EV + ZIM

EXPERIMENTAL

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

Sacituzumab Govitecan-hziy DRUG

Administered intravenously.

Also known as: IMMU-132, Trodelvy™

Cohort 1: Sacituzumab Govitecan-hziy (SG); Cohort 2: SG; Cohort 3: SG + Pembrolizumab; Cohort 4: SG + Cisplatin + Avelumab (Dose Escalation Phase); Cohort 4: SG + Cisplatin + Zimberelimab (ZIM) (Dose Expansion Phase); Cohort 5 (Arm 1): SG + ZIM; Cohort 6 (Arm 1): SG; Cohort 6 (Arm 2): SG + ZIM; Cohort 6 (Arm 3): SG + ZIM + Domvanalimab (DOM); Cohort 7 (Phase 1: Safety Lad-in and Dose Expansion): SG + Enfortumab Vedotin (EV) + ZIM; Cohort 7 (Phase 2: Arm 1): SG + EV + ZIM; Cohort 7 (Phase 2: Arm 3): Optional Dose Optimization SG + EV + ZIM

Pembrolizumab DRUG

Administered per package insert

Also known as: KEYTRUDA®

Cohort 3: SG + Pembrolizumab

Cisplatin DRUG

Administered per package insert

Cohort 4: SG + Cisplatin + Avelumab (Dose Escalation Phase); Cohort 4: SG + Cisplatin + Zimberelimab (ZIM) (Dose Expansion Phase)

Avelumab DRUG

Administered per package insert

Also known as: BAVENCIO®

Cohort 4: SG + Cisplatin + Avelumab (Dose Escalation Phase); Cohort 5 (Arm 2): Avelumab; Cohort 6 (Arm 4): Carboplatin (CARBO) + Gemcitabine (GEM)

Zimberelimab DRUG

Administered intravenously

Cohort 4: SG + Cisplatin + Zimberelimab (ZIM) (Dose Expansion Phase); Cohort 5 (Arm 1): SG + ZIM; Cohort 5 (Arm 3): ZIM; Cohort 6 (Arm 2): SG + ZIM; Cohort 6 (Arm 3): SG + ZIM + Domvanalimab (DOM); Cohort 7 (Phase 1: Safety Lad-in and Dose Expansion): SG + Enfortumab Vedotin (EV) + ZIM; Cohort 7 (Phase 2: Arm 1): SG + EV + ZIM; Cohort 7 (Phase 2: Arm 2): EV + ZIM; Cohort 7 (Phase 2: Arm 3): Optional Dose Optimization SG + EV + ZIM

Carboplatin DRUG

Administered per package insert

Cohort 6 (Arm 4): Carboplatin (CARBO) + Gemcitabine (GEM)

Gemcitabine DRUG

Administered per package insert

Cohort 6 (Arm 4): Carboplatin (CARBO) + Gemcitabine (GEM)

Domvanalimab DRUG

Administered intravenously

Cohort 6 (Arm 3): SG + ZIM + Domvanalimab (DOM)

Enfortumab Vedotin DRUG

Administered intravenously

Cohort 7 (Phase 1: Safety Lad-in and Dose Expansion): SG + Enfortumab Vedotin (EV) + ZIM; Cohort 7 (Phase 2: Arm 1): SG + EV + ZIM; Cohort 7 (Phase 2: Arm 2): EV + ZIM; Cohort 7 (Phase 2: Arm 3): Optional Dose Optimization SG + EV + ZIM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Gilead Sciences: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (135)

The University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States

RECRUITING

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

WITHDRAWN

University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

Rocky Mountain Cancer Centers

Littleton, Colorado, 80120, United States

RECRUITING

Smilow Cancer Hospital at Yale-New Haven

New Haven, Connecticut, 06510, United States

RECRUITING

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

WITHDRAWN

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

RECRUITING

Woodlands Medical Specialists, PA

Pensacola, Florida, 32503, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

COMPLETED

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Southern Illinois University School of Medicine, Simmons Cancer Institute

Springfield, Illinois, 62702, United States

RECRUITING

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

WITHDRAWN

Norton Cancer Institute, Downtown

Louisville, Kentucky, 40202, United States

RECRUITING

Maryland Oncology Hematology, P.A.

Brandywine, Maryland, 20613, United States

WITHDRAWN

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Oncology Hematology West PC dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

WITHDRAWN

Precision Cancer Research / New Mexico Oncology & Hematology Consultants

Albuquerque, New Mexico, 87109, United States

COMPLETED

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Drug Shipping Address: New York-Presbyterian Hospital

New York, New York, 10065, United States

RECRUITING

Stony Brook Cancer Center

Stony Brook, New York, 11794, United States

COMPLETED

St. Luke's Hosptial - Bethlehem Campus

Easton, Pennsylvania, 18045, United States

RECRUITING

Medical University of Southern Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Thompson Oncology Group - Knoxville West

Knoxville, Tennessee, 37932, United States

RECRUITING

Henry-Joyce Cancer Clinic

Nashville, Tennessee, 37232, United States

RECRUITING

Houston Methodist Hospital, Houston Methodist Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Mays Cancer Center

San Antonio, Texas, 78229, United States

RECRUITING

Renovatio Clinical

The Woodlands, Texas, 77380, United States

WITHDRAWN

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

Salt Lake City, Utah, 84112, United States

RECRUITING

University of Virginia Cancer Center

Charlottesville, Virginia, 22903, United States

WITHDRAWN

Virginia Oncology Associates

Hampton, Virginia, 23666, United States

RECRUITING

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

Roanoke, Virginia, 24014, United States

RECRUITING

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

RECRUITING

University of Wisconsin Clinical Science Center

Madison, Wisconsin, 53705, United States

RECRUITING

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

Besançon, 25000, France

RECRUITING

Hopital Saint Andre (CHU de Bordeaux)

Bordeaux, 33000, France

RECRUITING

Centre Hospitalier Regional Universitaire Brest

Brest, 29200, France

RECRUITING

Centre Jean Perrin

Clermont-Ferrand, 63011, France

RECRUITING

Centre Hospitalier Departmental (CHD) Vendee

La Roche-sur-Yon, 85925, France

RECRUITING

Centre Oscar Lambret

Lille, 59000, France

RECRUITING

Centre Leon Berard

Lyon, 69373, France

RECRUITING

Institut Paoli Calmettes

Marseille, 13273, France

RECRUITING

Centre Antoine Lacassagne

Nice, 06189, France

RECRUITING

Centre Hospitalier Universitaire De Nimes - Hopital Universitaire Caremeau

Nîmes, 30029, France

RECRUITING

Hopital European Georges-Pompidou (HEGP)

Paris, 33000, France

RECRUITING

Groupement Hospitalier Pitie-Salpetriere

Paris, 75013, France

RECRUITING

Hopital Cochin

Paris, 75014, France

RECRUITING

Centre Hospitalier Prive Saint-Gregoire

Rennes, 35000, France

RECRUITING

Centre Eugene Marquis

Rennes, 35042, France

RECRUITING

CHU de Rouen

Rouen, 76031, France

RECRUITING

Hospitaux Universitaires de Strasbourg - Hopital Civil

Strasbourg, 67200, France

RECRUITING

Hospital Foch

Suresnes, 92150, France

RECRUITING

Institut Claudius Regaud

Toulouse, 31059, France

RECRUITING

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94800, France

RECRUITING

Urologicum Duisburg

Duisburg, 47179, Germany

COMPLETED

Centrum fur Hamatologie und Onkologie Bethanien

Frankfurt, 60389, Germany

RECRUITING

Universitätsklinikum Frankfurt, Klinik für Urologie

Frankfurt, 60590, Germany

RECRUITING

Universitatsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

RECRUITING

Universitatsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

University Hospital Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Marien Hospital Herne

Herne, 44625, Germany

RECRUITING

Universitatsklinikum Jena

Jena, 07743, Germany

RECRUITING

Institut für Versorgungsforschung in der Onkologie

Koblenz, 56068, Germany

RECRUITING

Universitätsklinikum Magdeburg

Magdeburg, 39120, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Mainz, 55131, Germany

RECRUITING

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

München, 81675, Germany

RECRUITING

Universitatsklinikum Munster, Klinik fur Urologie und Kinderurologie

Münster, 48149, Germany

RECRUITING

Universitat Regensburg

Regensburg, 93053, Germany

RECRUITING

Universitatsklinikum Tubingen, Klinik fur Urologie

Tübingen, 72076, Germany

RECRUITING

Henry Dunant Hospital Center, 4th Oncology Department

Athens, 11526, Greece

RECRUITING

University General Hospital of Ioannina, Oncology Department

Ioannina, 45500, Greece

RECRUITING

Athens Medical Center, Oncology Department

Marousi, 15125, Greece

RECRUITING

General Hospital of Patras Agios Andreas

Pátrai, 26335, Greece

RECRUITING

Anassa General Clinic, Oncology-Chemotherapy Department

Volos, 38333, Greece

RECRUITING

Ospedale San Donato

Arezzo, 52100, Italy

RECRUITING

Centro di Riferimento Oncologico IRCCS

Aviano, 33081, Italy

RECRUITING

ASST Cremona

Cremona, 26100, Italy

RECRUITING

Ospedale Policlinico San Martino IRCCS

Genoa, 16132, Italy

RECRUITING

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

Meldola, 47014, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, 20133, Italy

RECRUITING

Azienda Ospedaliero Universitaria Maggiore della Carita

Novara, 28100, Italy

RECRUITING

Istituto Oncologico Veneto IRCCS - Ospedale Busonera

Padua, 35128, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Pisana

Pisa, 56126, Italy

RECRUITING

Instituto Nazionale Tumori Regina Elena - IFO

Roma, 00144, Italy

RECRUITING

Azienda Ospedaliera Santa Maria di Temi

Terni, 05100, Italy

RECRUITING

Centro Ricerche Cliniche di Verona srl

Verona, 37126, Italy

RECRUITING

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

RECRUITING

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

RECRUITING

National Cancer Center

Goyang-si, 10408, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, 61469, South Korea

RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, 519-763, South Korea

RECRUITING

Korea University - Anam Hospital

Seongbuk-Gu, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Yonsei University Health System, Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

RECRUITING

Asan Medical Center

Seoul, 5505, South Korea

RECRUITING

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

Suwon, 16247, South Korea

RECRUITING

Yonsei University - Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

NOT YET RECRUITING

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

RECRUITING

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

Badalona, 08916, Spain

ACTIVE NOT RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08023, Spain

RECRUITING

CEIC Hospital Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas, 35016, Spain

RECRUITING

MD Anderson Cancer Centre

Madrid, 28033, Spain

RECRUITING

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Universitario Puera de Hierro Majadahonda

Majadahonda, 28222, Spain

RECRUITING

Hospital Sant Joan de Deu

Manresa, 08243, Spain

RECRUITING

Complejo Hospitalario de Ourense

Ourense, 32005, Spain

RECRUITING

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

RECRUITING

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, 15706, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

RECRUITING

Ankara Sehir Hastanesi

Ankara, 06550, Turkey (Türkiye)

RECRUITING

Dicle Universitesi Tip Fakultesi Hastanesi

Diyarbakır, 21280, Turkey (Türkiye)

RECRUITING

Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

Edrine, 22030, Turkey (Türkiye)

RECRUITING

Istanbul Universitesi Cerrahpasa Tip Fakultesi Hastanesi

Istanbul, 34098, Turkey (Türkiye)

RECRUITING

Medipol Mega Universite Hastanesi

Istanbul, 34214, Turkey (Türkiye)

RECRUITING

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

Istanbul, 34722, Turkey (Türkiye)

RECRUITING

Izmir Medical Point Hastanesi, Medikal Onkoloji Departmant

Izmir, 35575, Turkey (Türkiye)

RECRUITING

Baskent Universitesi Adana Dr.Turgut Noyan Uygulama ve Arastima Merkezi

Seyhan, 01250, Turkey (Türkiye)

RECRUITING

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B9 5SS, United Kingdom

RECRUITING

Barts Health NHS Trust

London, E1 1BB, United Kingdom

RECRUITING

East and North Hertfordshire NHS Trust

Northwood, HA6 2JW, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust

Surrey, SM2 5PT, United Kingdom

RECRUITING

Related Publications (4)

• 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.

  PMID: 39186707 DERIVED

• 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.

  PMID: 38682560 DERIVED

• 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.

  PMID: 38261969 DERIVED

• 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.

  PMID: 33929895 DERIVED

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

sacituzumab govitecan; pembrolizumab; Cisplatin; avelumab; zimberelimab; Carboplatin; Gemcitabine; enfortumab vedotin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0); GileadClinicalTrials@gilead.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: June 6, 2018
• Study Start: August 13, 2018
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (8); GR (5); US (37); IT (13); ES (18); KR (14); GB (4); FR (21); DE (15)