TROPiCS-04: Study of Sacituzumab Govitecan-hziy (IMMU-132) Versus Treatment of Physician's Choice in Participants With Metastatic or Locally Advanced Unresectable Urothelial Cancer

• Sponsor: Gilead Sciences (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04527991
• Collaborator: Everest Medicines (Industry)
• Enrollment: 696
• Locations: 225
• Arms: 2
• Anticipated Duration (Months): 35.6
• Patients Per Site: 3.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced or Metastatic Unresectable Urothelial Cancer	Biological: Sacituzumab Govitecan-hziy; Drug: Paclitaxel; Drug: Docetaxel; Drug: Vinflunine	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 696 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects With Metastatic or Locally Advanced Unresectable Urothelial Cancer
• Actual Study Start Date: Jan 13, 2021
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sacituzumab Govitecan-hziy Participants will receive 10 mg/kg of sacituzumab govitecan-hziy intravenously on Day 1 and Day 8 of 21-day cycles.	Biological: Sacituzumab Govitecan-hziy; Administered intravenously; Other Names: IMMU-132 Trodelvy™ GS-0132
Active Comparator: Treatment of Physician's Choice Participants will have the choice of receiving paclitaxel, docetaxel, or vinflunine at standard of care (SOC) doses of 175, 75, and 320 mg/m^2 respectively, every 3 weeks on Day 1 of 21-day cycles.	Drug: Paclitaxel; Administered intravenously; Other Names: Taxol® ; Drug: Docetaxel; Administered intravenously; Other Names: Taxotere® ; Drug: Vinflunine; Administered intravenously; Other Names: Javlor ®

Outcome Measures

Primary Outcome Measures

1. Overall Survival (OS) [Up to 3.5 years]

   OS is defined as time from the date of randomization to the date of death, regardless of cause.

Secondary Outcome Measures

1. Progression-Free Survival (PFS) by Investigator Assessment [Up to 3.5 years]

   PFS is defined as the time from the date of randomization to the date of the first objectively documented disease progression, per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) criteria, as determined by investigator assessment, or death regardless of cause, whichever occurs first.

2. Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Up to 3.5 years]

   PFS is defined as the time from the date of randomization to the date of the first objectively documented disease progression, per RECIST v1.1 criteria as determined by BICR, or death regardless of cause, whichever occurs first.

3. Objective Response Rate (ORR) by Investigator Assessment [Up to 3.5 years]

   ORR is defined as the proportion of participants who achieved a complete response or partial response as best overall response (BOR). BOR is determined per RECIST 1.1 as determined by investigator assessment.

4. Objective Response Rate (ORR) by BICR [Up to 3.5 years]

   ORR is defined as the proportion of participants who achieved a complete response or partial response as best overall response (BOR). BOR is determined per RECIST 1.1 as determined by BICR.

5. Clinical Benefit Rate (CBR) by Investigator Assessment [Up to 3.5 years]

   CBR is defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease for greater than or equal to 6 months to therapeutic intervention in a clinical study. CBR will be determined per RECIST v1.1 by investigator assessment.

6. Clinical Benefit Rate (CBR) by BICR [Up to 3.5 years]

   CBR is defined as the percentage of participants with advanced or metastatic cancer who have achieved complete response, partial response and stable disease for greater than or equal to 6 months to therapeutic intervention in a clinical study. CBR will be determined per RECIST v1.1 by BICR.

7. Duration of Objective Tumor Response (DOR) by Investigator Assessment [Up to 3.5 years]

   DOR is defined as the time from the date when the criteria is first met for a complete response or partial response to the first date that disease progression is documented per RECIST 1.1 as determined by investigator assessment, or date of death, whichever occurs first.

8. Duration of Objective Tumor Response (DOR) by BICR [Up to 3.5 years]

   DOR is defined as the time from the date when the criteria is first met for a complete response or partial response to the first date that disease progression is documented per RECIST 1.1 as determined by BICR, or date of death, whichever occurs first.

9. Percentage of Participants Experiencing any Treatment Emergent Adverse Events [Up to 3.5 years]

10. Percentage of Participants Experiencing any Serious Treatment Emergent Adverse Events [Up to 3.5 years]

11. Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities [Up to 3.5 years]

12. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Score [Up to 3.5 years]

    The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).

13. European Quality of Life 5-Dimensions 5 Levels Instrument (EuroQOL EQ-5D-5L) Score [Up to 3.5 years]

    The EQ-5D-5L is a standard measure of health-related quality of life. The tool consists of the EQ-5D-5L descriptive part and the EQ visual analogue scale (VAS). The descriptive part comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each of these 5 dimensions has 5 levels (no problem, slight problems, moderate problems, severe problems, and extreme problems). Results for each of the 5 dimensions are combined into a 5-digit number to describe the participant's health state. The EQ-VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating "the worst health you can imagine" and 100 indicating "the best health you can imagine." Higher scores of EQ VAS indicate better health.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

1. Individuals with histologically documented metastatic or locally advanced unresectable UC defined as

• Tumor (T) 4b, any node (N) or

• Any T, N 2-3 Tumors of upper and lower urinary tract are permitted. Mixed histologic types are allowed if urothelial is the predominant histology.

1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.

2. Individuals with progression or recurrence following receipt of platinum-containing regimen and anti programmed cell death protein 1/programmed death-ligand 1 (PD-1/PD-L1) therapy for metastatic or locally advanced unresectable disease will be enrolled.

• 1. Individuals with recurrence or progression ≤12 months following completion of cisplatin-containing chemotherapy given in the neo-adjuvant/adjuvant setting may utilize that line of therapy to be eligible for the study. The 12-month period is counted from completion of surgical intervention or platinum therapy, respectively. These individuals must receive anti PD-1/PD-L1 therapy in the metastatic or locally advanced unresectable setting to be eligible.
• 1. Individuals who received either carboplatin or anti PD-1/PD-L1 therapy in the neo- adjuvant/adjuvant setting will not be able to count that line of therapy towards eligibility for the study.
• 1. Cisplatin ineligible individuals who meet one of the below criteria and who were treated with carboplatin in the metastatic or locally advanced unresectable settings may count that line of therapy towards eligibility. They must then have received anti PD-1/PD-L1 therapy in metastatic or locally advanced unresectable setting to be eligible for the study.

• Cisplatin ineligibility is defined as meeting one of the following criteria:

• 1. Creatinine Clearance < 60 mL/min
• 1. Grade ≥ 2 Audiometric Hearing Loss
• 1. Grade ≥ 2 Peripheral Neuropathy
• 1. New York Heart Association (NYHA) Class III heart failure
• 1. ECOG PS ≥ 2
• 1. Anti PD-1/PD-L1 therapy administered as part of maintenance therapy may be counted towards eligibility for the study
• 1. Individuals who have progressed after receiving enfortumab vedotin in prior lines of therapy, and individuals who are either ineligible or unable to tolerate enfortumab vedotin therapy, are eligible to enroll in the study
• 1. Individuals who received only concurrent chemoradiation for bladder preservation without further systemic therapy are not eligible to enroll in the study. The substitution of carboplatin for cisplatin does not constitute a new regimen provided no new chemotherapeutic agents were added to the regimen and no progression was noted prior to the change in platinum.

1. Individuals with previously treated brain metastases may participate in the study provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and stabilization of all neurologic symptoms, have no evidence of new or enlarging brain metastases, and are not using steroids >20 mg of prednisone (or equivalent) daily for brain metastases for at least 7 days prior to first dose of the study drug.

2. Adequate hematologic counts without transfusion or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥1,500/mm^3, and platelets ≥100,000/µL).

3. Adequate hepatic function (bilirubin ≤1.5x institutional upper limit of normal (IULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x IULN or ≤ 5 x IULN if known liver metastases and serum albumin >3 g/dL).

Docetaxel will only be option in TPC arm for Individuals with a total bilirubin ≤1 x IULN, and an AST and/or ALT ≤1.5x IULN if alkaline phosphatase is also >2.5 x IULN.

1. Creatinine clearance ≥30 mL/min as assessed by the Cockcroft-Gault equation or other validated instruments (e.g. Modification of Diet in Renal Disease (MDRD) equation).

2. Females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

3. Females of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study drug. Individuals of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >2 years.

4. Males must agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy.

Key Exclusion Criteria:

1. Females who are pregnant or lactating.

2. Have had a prior anti-cancer monoclonal antibody (mAb)/ antibody-drug conjugate (ADC) within 4 weeks prior to Cycle 1 Day 1 (C1D1) or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to C1D1. Individuals participating in observational studies are eligible.

3. Have received prior chemotherapy for UC with any available SOC therapies in the control arm (i.e., both prior paclitaxel and docetaxel in regions where vinflunine is not an approved therapy, or prior paclitaxel, docetaxel and vinflunine in regions where vinflunine is approved and is commercially available).

4. Have not recovered (i.e., ≤ Grade 1) from AEs due to previously administered chemotherapeutic agent.

• Note: Individuals with ≤ Grade 2 neuropathy or any grade of alopecia are an exception to this criterion and will qualify for the study.

• Note: If Individuals received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study therapy.

1. Have previously received topoisomerase 1 inhibitors.

2. Have an active second malignancy.

• Note: Individuals with a history of malignancy that have been completely treated and with no evidence of active cancer for 3 years prior to enrollment, or individuals with surgically cured tumors with low risk of recurrence are allowed to enroll in the study after discussion with the medical monitor.

1. Have active cardiac disease, defined as:

• Myocardial infarction or unstable angina pectoris within 6 months of C1D1.

• History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.

• NYHA Class III or greater congestive heart failure or left ventricular ejection fraction of <40%.

1. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal (GI) perforation within 6 months of enrollment.

2. Have an active serious infection requiring anti-infective therapy (Contact medical monitor for clarification).

3. Have known history of Human Immunodeficiency Virus (HIV)-1/2 with undetectable viral load and on medications that may interfere with SN-38 metabolism.

4. Have active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV). In individuals with a history of HBV or HCV, individuals with a detectable viral load will be excluded.

5. Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

6. Have inability to tolerate or are allergic to any potential TPC agent or sacituzumab govitecan-hziy or unable or unwilling to receive the doses specified in the protocol.

7. Have inability to complete all specified study procedures for any reason.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic - Arizona	Phoenix	Arizona	United States	85054
2	UCLA Hematology/ Oncology	Los Angeles	California	United States	90095
3	University of California Irvine (UCIMC)	Orange	California	United States	92868
4	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
5	Baptist MD Anderson Cancer Center	Jacksonville	Florida	United States	32207
6	Boca Raton Clinical Research Global USA - Plantation	Plantation	Florida	United States	33322
7	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
8	University of Maryland School of Medicine	Baltimore	Maryland	United States	21201
9	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
10	Montefiore Medical Center	Bronx	New York	United States	10467
11	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
12	Weill Cornell Medical College	New York	New York	United States	10065
13	Cleveland Clinic	Cleveland	Ohio	United States	44195
14	Oklahoma Cancer Specialists and Research Institute (OCSRI)	Tulsa	Oklahoma	United States	74104
15	Penn State Hershey Cancer Institute	Hershey	Pennsylvania	United States	17033
16	Thompson Oncology Group - Knoxville Downtown	Knoxville	Tennessee	United States	37916
17	University Cancer Specialists - Knoxville	Knoxville	Tennessee	United States	37920
18	Harold C. Simmons Comprehensive Cancer Center	Dallas	Texas	United States	75390
19	Center for Cancer and Blood Disorders	Fort Worth	Texas	United States	76104
20	Seattle Cancer Care Alliance (SCCA)	Seattle	Washington	United States	98109
21	Summit Cancer Centers	Spokane	Washington	United States	99208
22	Chris O'Brien Lifehouse	North Ryde	New South Wales	Australia	2109
23	Calvary Mater Newcastle	Waratah	New South Wales	Australia	2298
24	Westmead Hospital	Westmead	New South Wales	Australia	2145
25	Icon Cancer Centre Wesley	Auchenflower	Queensland	Australia	4066
26	Southern Adelaide Local Health Network Incorporated	Bedford Park	South Australia	Australia	5042
27	Ashford Cancer Centre Research - ICON Cancer Centre Adelaide	Kurralta Park	South Australia	Australia	5037
28	ICON Cancer Centre Hobart	Hobart	Tasmania	Australia	7001
29	Monash Health	Clayton	Victoria	Australia	3168
30	Austin Health	Heidelberg	Victoria	Australia	3084
31	Peter MacCallum Cancer Centre	Melbourne	Victoria	Australia	3000
32	Sunshine Hospital	Saint Albans	Victoria	Australia	3021
33	Liverpool Hospital	Nedlands	Western Australia	Australia	6009
34	Sir Charles Gairdner Hospital	Nedlands	Western Australia	Australia	6009
35	Universitätsklinik für Innere Medizin Graz	Graz		Austria	8036
36	Ordensklinikum Linz GmbH Barmherzige Schwestern	Linz		Austria	4010
37	Krankenhaus Der Barmherzigen Bruder Wien	Wien		Austria	1020
38	Grand Hôpital De Charleroi - Notre Dame	Charleroi		Belgium	6000
39	Az Maria Middelares Ghent	Gent		Belgium	9000
40	Universitair Ziekenhuis Gent	Gent		Belgium	9000
41	Universitair Ziekenhuis Leuven	Leuven		Belgium	3000
42	Centre Hospitalier Universitaire de Liège	Liège		Belgium	B-4000
43	Multiprofile Hospital for Active Treatment Heart and Brain EAD	Pleven		Bulgaria	5800
44	Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District	Sofia		Bulgaria	1233
45	Cross Cancer Institute	Edmonton		Canada	T6G 1Z2
46	qeii health sciences centre - VG site	Halifax		Canada	B3H 2Y9
47	Juravinski Hospital and Cancer Centre	Hamilton		Canada	L8V 5C2
48	London Health Sciences Centre	London		Canada	N6A 4G5
49	Jewish General Hospital	Montréal		Canada	H3T 1E2
50	McGill University Health Centre	Montréal		Canada	H4A 3J1
51	R.S. McLaughlin Durham Regional Cancer Centre	Oshawa		Canada	L1G 2B9
52	Princess Margaret Cancer Centre	Toronto		Canada	M5G 2M9
53	British Columbia Cancer Agency-Vancouver Centre	Vancouver		Canada	V5Z 4E6
54	Peking University First Hospital	Beijing		China	100034
55	Chinese People's Liberation Army General Hospital - 301 Hospital	Beijing		China	100039
56	Beijing Cancer Hospital	Beijing		China	100142
57	Chinese Academy of Medical Sciences Cancer Hospital	Beijing		China	100730
58	1st Hospital Jilin University	Changchun		China	130021
59	Hunan Cancer Hospital - Xiangya Hospital - Central South University	Changsha		China	410013
60	West China Hospital Sichuan University	Chengdu		China	610041
61	Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital	Chengdu		China	610072
62	Chongqing University Cancer Hospital	Chongqing		China	400030
63	The First Affiliated Hospital of Fujian Medical University	Fujian		China	350005
64	Union Hospital of Fujian Medical University	Fuzhou		China	350001
65	Sun Yat-Sen University Cancer Center	Guangzhou		China	510060
66	Zhejiang Provincial People's Hospital - Zhaohui	Hangzhou		China	310014
67	Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital	Hangzhou		China	310022
68	Anhui Provincial Cancer Hospital	Hefei		China	230031
69	Qilu Hospital of Shandong University	Jinan		China	250012
70	The First Affiliated Hospital of Nanchang University	Nanchang		China	330006
71	Nanjing Drum Tower Hospital	Nanjing		China	210008
72	Liaoning Cancer Hospital and Institute	Shenyang		China	110042
73	Tianjin Medical University Cancer Institute & Hospital	Tianjin		China	300060
74	Affiliated Tumor Hospital of Xinjiang Medical University	Urumqi		China	830000
75	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou		China	325000
76	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan		China	430030
77	Clinical Hospital Centre Split	Split		Croatia	21000
78	Clinical Hospital Centre "Sestre Milosrdnice"	Zagreb		Croatia	10000
79	University Hospital Centre Zagreb	Zagreb		Croatia	10000
80	Fakultni nemocnice Olomouc	Olomouc		Czechia	775 20
81	Urocentrum Praha	Praha 2		Czechia	120 00
82	Ramsay Health Clinic Belharra	Bayonne		France
83	CHU Saint Andre	Bordeaux		France	33075
84	Centre Hospiltalier Universitaire Brest - Hôpital Morvan	Brest		France	29200
85	Centre Francois Baclesse	Caen Cedex 5		France	14076
86	Centre Jean Perrin	Clermont-Ferrand		France	63011
87	Centre Georges- Francois Leclerc	Dijon		France	21000
88	Centre Hospitalier Departemental Vendee	La Roche-Sur-Yon Cedex		France	85925 CEDEX 9
89	Centre Oscar Lambret	Lille		France	59000
90	Centre Leon Berard	Lyon		France	69373
91	Institut Régional du Cancer de Montpellier ICM Val d' Aurelle	Montpellier		France	34090
92	Centre Antoine Lacassagne	Nice Cedex 2		France	06189
93	Centre Hospitalier Universitaire de Nimes	Nimes		France	30029
94	Hôpital Européen Georges-Pompidou	Paris		France	75015
95	Centre Eugene Marquis	Rennes Cedex		France	35042
96	Institut de Cancérologie de l'Ouest	Saint Herblain Cedex		France	44805
97	Centre Hospitalier Privé Saint-Grégoire	Saint-Grégoire		France	35760
98	Les Hôpitaux Universitaires de Strasbourg	Strasbourg cedex		France	67091
99	Hôpital Foch	Suresnes		France	92150
100	Institut Claudius Regaud	Toulouse Cedex 9		France	31059
101	Institut Gustave Roussy	Villejuif Cedex		France	94805
102	High Technology Hospital MedCenter	Batumi		Georgia	6000
103	New Hospitals	Tbilisi		Georgia	0114
104	L. Managadze National Center of Urology	Tbilisi		Georgia	0144
105	Evex Medical corporation	Tbilisi		Georgia	0160
106	Jerarsi Clinic	Tbilisi		Georgia	0167
107	Universitatsklinik Dresden	Dresden		Germany	01307
108	Universitätsklinikum Essen	Essen		Germany	45147
109	Centrum fur Hamatologie und Onkologie Bethanien	Frankfurt/Main		Germany	60389
110	Asklepios Klinik Altona	Hamburg		Germany	22763
111	Institut Für Versorgungsforschung in Der Onkologie	Koblenz		Germany	56068
112	Universitatsklinikum Munster	Münster		Germany	48149
113	Studienpraxis Urologie	Nürtingen		Germany	72622
114	Universitätsklinikum Tübingen	Tübingen		Germany	72076
115	Charité Universitätsmedizin Berlin - Campus Benjamin Franklin	Wien		Germany	1100
116	401 General Military Hospital of Athens	Athens		Greece	115 25
117	Henry Dunant Hospital	Athens		Greece	115 26
118	Alexandra General Hospital	Athens		Greece	11528
119	Attikon Hospital	Chaidari		Greece	124 62
120	Regional University General Hospital of Herakleio, Crete	Herakleio		Greece	81352
121	University Hospital Of Ioannina	Ioannina		Greece	45332
122	University Hospital of Larissa	Larisa		Greece	413 34
123	Athens Medical Center	Maroussi		Greece	151 25
124	University Hospital of Patras	Patra		Greece	26332
125	Bioclinic - Thessaloniki	Thessaloniki		Greece	546 22
126	Theagenio Anticancer Hospital of Thessaloniki	Thessaloniki		Greece	546 39
127	Anassa General Clinic	Thessaloniki		Greece	54623
128	Interbalkan Medical Center of Thessaloniki	Thessaloniki		Greece	555 35
129	Prince of Wales Hospital	Hong Kong		Hong Kong	0
130	Queen Mary Hospital	Hong Kong		Hong Kong
131	Hong Kong United Oncology Centre	Kowloon		Hong Kong
132	Tallaght University Hospital	Dublin		Ireland	D24 NR0A
133	University Hospital Waterford	Waterford		Ireland	X91 ER8E
134	Shamir Medical Center (Assaf Harofeh)	Be'er Ya'akov		Israel	7030000
135	Rambam Health Care Campus	Haifa		Israel	3109601
136	Hadassah University Hospital Ein Kerem	Jerusalem		Israel	91120
137	Meir Medical Center	Kfar-Sava		Israel	44281
138	Rabin Medical Center	Petach Tikva		Israel	4941492
139	Tel Aviv Medical Center (Ichilov Hospital)	Tel Aviv		Israel	6423906
140	Chaim Sheba Medical Center	Tel Hashomer		Israel	52621
141	Ospedale San Donato	Arezzo		Italy	52100
142	Centro di Riferimento Oncologico di Aviano	Aviano		Italy	33081
143	Istituto Tumori Bari Giovanni Paolo II - IRCCS	Bari		Italy	70124
144	Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia	Candiolo (TO)		Italy	10060
145	Ospedale Policlinico San Martino	Genova		Italy	16132
146	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori	Meldola		Italy	47014
147	Ospedale San Raffaele	Milan		Italy	20132
148	Azienda Ospedaliero Universitaria Maggiore Della Carita	Novara		Italy	28100
149	Azienda Ospedaliero Universitaria Pisana	Pisa		Italy	56126
150	Istituto Regina Elena	Roma		Italy	00144
151	Università Campus Bio-Medico di Roma	Rome		Italy	00128
152	Ospedale Civile Di Sondrio	Sondrio		Italy	23100
153	Azienda Ospedaliera Santa Maria di Terni	Terni		Italy	05100
154	Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Torino		Italy	10043
155	Ospedale di Trento - Presidio Ospedaliero Santa Chiara	Trento		Italy	38122
156	Azienda Ospedaliera Universitaria Integrata Verona	Verona		Italy	37126
157	Pusan National University Hospital	Busan-si		Korea, Republic of	49241
158	Chungbuk National University Hospital	Cheongju		Korea, Republic of	361-711
159	Chungnam National University Hospital	Daejeon		Korea, Republic of	35015
160	National Cancer Center	Goyang-si		Korea, Republic of	10408
161	Pusan National University Yangsan Hospital	Gyeongsangnam-do		Korea, Republic of	50612
162	Gachon University Gil Medical Center	Incheon		Korea, Republic of	405-760
163	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of	13620
164	Seoul National University Hospital	Seoul		Korea, Republic of	03080
165	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722
166	Asan Medical Center	Seoul		Korea, Republic of	05505
167	Samsung Medical Center	Seoul		Korea, Republic of	06351
168	The Catholic University of Korea Seoul Saint Mary's Hospital	Seoul		Korea, Republic of	137-040
169	The Catholic University of Korea Saint Vincent's Hospital	Suwon		Korea, Republic of	16247
170	Hospital de Braga	Braga		Portugal	4710-243
171	Unidade Local de Saúde da Guarda - Hospital Sousa Martins	Guarda		Portugal	6300-858
172	Centro Hospitalar de Leiria - Hospital de Santo André	Leiria		Portugal	2410-197
173	Centro Hospitalar de Lisboa Norte - Hospital de Santa Maria	Lisbon		Portugal	1649-035
174	Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E	Porto		Portugal
175	Centro Hospitalar de Tras-os-Montes e Alto Douro	Vila Real		Portugal	5000
176	BRCR Medical Center, Inc	San Juan		Puerto Rico	00907
177	National University Hospital	Singapore		Singapore	119074
178	Icon Cancer Centre Farrer Park	Singapore		Singapore	217562
179	Tan Tock Seng Hospital	Singapore		Singapore	308433
180	Hospital del Mar - Parc de Salut	Barcelona		Spain	08003
181	Hospital Universitari Vall D'Hebron	Barcelona		Spain	08035
182	Hospital Clinic de Barcelona	Barcelona		Spain	8036
183	Hospital Reina Sofia	Córdoba		Spain	14004
184	Hospital General Universitario Gregorio Maranon	Madrid		Spain	28007
185	Clínica Universidad de Navarra - Madrid	Madrid		Spain	28027
186	MD Anderson Cancer Center	Madrid		Spain	28033
187	Hospital Universitario Ramon y Cajal	Madrid		Spain	28034
188	Hospital Universitario Puerta de Hierro de Majadahonda	Majadahonda		Spain	28222
189	Hospital Sant Joan de Déu de Manresa	Manresa		Spain	08243
190	Complexo Hospitalario de Ourense (CHOU)	Ourense		Spain	32005
191	Clinica Universidad de Navarra	Pamplona		Spain	31008
192	Hospital Universitario Marqués de Valdecilla	Santander		Spain	39008
193	Hospital Universitario Virgen del Rocio	Sevilla		Spain	41013
194	Álvaro Cunqueiro Hospital	Vigo		Spain	36213
195	Länssjukhuset Ryhov	Jönköping		Sweden	553 05
196	Universitetssjukhuset i Linköping	Linköping		Sweden	581 85
197	Karolinska Universitetssjukhuset - Solna	Stockholm		Sweden	171 76
198	University Hospital Basel	Basel		Switzerland	4051
199	Istituto Oncologico Della Svizzera Italiana (IOSI)	Bellinzona		Switzerland	6500
200	University of Bern	Bern		Switzerland	3010
201	Hôpitaux Universitaires de Genève	Geneva		Switzerland	1205
202	Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie	Zurich		Switzerland	8091
203	Kaohsiung Veterans General Hospital	Kaohsiung		Taiwan	813
204	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan	833
205	Taipei Tzu Chi General Hospital	New Taipei City		Taiwan	231405
206	Chiayi Chang Gung Memorial Hospital	Puzi		Taiwan	613
207	China Medical University Hospital	Taichung City		Taiwan	40447
208	Taichung Veterans General Hospital	Taichung		Taiwan	Taiwan 407
209	National Cheng Kung University Hospital	Tainan		Taiwan	70403
210	National Taiwan University Hospital	Taipei City		Taiwan	100
211	Taipei Veterans General Hospital	Taipei City		Taiwan	11217
212	Chang Gung Memorial Hospital - Linkou Branch	Taoyuan		Taiwan	333
213	Cebeci Hastanesi	Mamak		Turkey	06620
214	Dorset County Hospital NHS Foundation Trust	Dorchester		United Kingdom	DT1 2JY
215	NHS Greater Glasgow and Clyde	Glasgow		United Kingdom	G12 0YN
216	Barts Health NHS Trust	London		United Kingdom	EC1A 7BE
217	Guys and Saint Thomas NHS Foundation Trust, Guy's Hospital	London		United Kingdom	SE1 9RT
218	Sarah Cannon Research Institute London	London		United Kingdom	W1G 6AD
219	The Christie NHS Foundation Trust	Manchester		United Kingdom	M20 4BX
220	East and North Hertfordshire NHS Trust	Middlesex		United Kingdom	HA6 2RN
221	Oxford University Hospitals NHS Foundation Trust	Oxford		United Kingdom	OX3 7LE
222	Swansea Bay University Health Board	Port Talbot		United Kingdom	SA12 7BR
223	Royal Preston Hospital	Preston		United Kingdom	PR2 9HT
224	The Royal Marsden NHS Foundation Trust	Surrey		United Kingdom	SM2 5PT
225	The Royal Wolverhampton NHS Trust	Wolverhampton		United Kingdom	WV10 0QP

Sponsors and Collaborators

• Gilead Sciences
• Everest Medicines

Investigators

• Study Director: Gilead Study Director, Gilead Sciences

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Gilead Clinical Trials Website

Publications

None provided.

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT04527991
• Other Study ID Numbers: IMMU-132-13; 2020-002964-29
• First Posted: Aug 27, 2020
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Paclitaxel; Docetaxel

Study Results

No Results Posted as of Aug 25, 2022