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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04527991




Registration number
NCT04527991
Ethics application status
Date submitted
19/08/2020
Date registered
27/08/2020

Titles & IDs
Public title
Study of Sacituzumab Govitecan-hziy (IMMU-132) Versus Treatment of Physician's Choice in Participants With Metastatic or Locally Advanced Unresectable Urothelial Cancer
Scientific 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
Secondary ID [1] 0 0
2020-002964-29
Secondary ID [2] 0 0
IMMU-132-13
Universal Trial Number (UTN)
Trial acronym
TROPiCS-04
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced or Metastatic Unresectable Urothelial Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sacituzumab Govitecan-hziy
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Docetaxel
Treatment: Drugs - Vinflunine

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.

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.


Treatment: Drugs: Sacituzumab Govitecan-hziy
Administered intravenously

Treatment: Drugs: Paclitaxel
Administered intravenously

Treatment: Drugs: Docetaxel
Administered intravenously

Treatment: Drugs: Vinflunine
Administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 3.5 years
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) by Investigator Assessment
Timepoint [1] 0 0
Up to 3.5 years
Secondary outcome [2] 0 0
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR)
Timepoint [2] 0 0
Up to 3.5 years
Secondary outcome [3] 0 0
Objective Response Rate (ORR) by Investigator Assessment
Timepoint [3] 0 0
Up to 3.5 years
Secondary outcome [4] 0 0
Objective Response Rate (ORR) by BICR
Timepoint [4] 0 0
Up to 3.5 years
Secondary outcome [5] 0 0
Clinical Benefit Rate (CBR) by Investigator Assessment
Timepoint [5] 0 0
Up to 3.5 years
Secondary outcome [6] 0 0
Clinical Benefit Rate (CBR) by BICR
Timepoint [6] 0 0
Up to 3.5 years
Secondary outcome [7] 0 0
Duration of Objective Tumor Response (DOR) by Investigator Assessment
Timepoint [7] 0 0
Up to 3.5 years
Secondary outcome [8] 0 0
Duration of Objective Tumor Response (DOR) by BICR
Timepoint [8] 0 0
Up to 3.5 years
Secondary outcome [9] 0 0
Percentage of Participants Experiencing any Treatment Emergent Adverse Events
Timepoint [9] 0 0
Up to 3.5 years
Secondary outcome [10] 0 0
Percentage of Participants Experiencing any Serious Treatment Emergent Adverse Events
Timepoint [10] 0 0
Up to 3.5 years
Secondary outcome [11] 0 0
Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities
Timepoint [11] 0 0
Up to 3.5 years
Secondary outcome [12] 0 0
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Score
Timepoint [12] 0 0
Up to 3.5 years
Secondary outcome [13] 0 0
European Quality of Life 5-Dimensions 5 Levels Instrument (EuroQOL EQ-5D-5L) Score
Timepoint [13] 0 0
Up to 3.5 years

Eligibility
Key inclusion criteria
Key

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.
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
3. 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.

* a. 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.
* b. 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.
* c. 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
* 2. Grade = 2 Audiometric Hearing Loss
* 3. Grade = 2 Peripheral Neuropathy
* 4. New York Heart Association (NYHA) Class III heart failure
* 5. ECOG PS = 2
* d. Anti PD-1/PD-L1 therapy administered as part of maintenance therapy may be counted towards eligibility for the study
* e. 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
* f. 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.
4. 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.
5. 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).
6. 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.
7. 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).
8. 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.
9. 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.
10. 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.
5. Have previously received topoisomerase 1 inhibitors.
6. 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.
7. 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%.
8. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal (GI) perforation within 6 months of enrollment.
9. Have an active serious infection requiring anti-infective therapy (Contact medical monitor for clarification).
10. Have known history of Human Immunodeficiency Virus (HIV)-1/2 with undetectable viral load and on medications that may interfere with SN-38 metabolism.
11. 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.
12. 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.
13. 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.
14. Have inability to complete all specified study procedures for any reason.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
696
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - North Ryde
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Icon Cancer Centre Wesley - Auchenflower
Recruitment hospital [5] 0 0
Southern Adelaide Local Health Network Incorporated - Bedford Park
Recruitment hospital [6] 0 0
Ashford Cancer Centre Research - ICON Cancer Centre Adelaide - Kurralta Park
Recruitment hospital [7] 0 0
ICON Cancer Centre Hobart - Hobart
Recruitment hospital [8] 0 0
Monash Health - Clayton
Recruitment hospital [9] 0 0
Austin Health - Heidelberg
Recruitment hospital [10] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [11] 0 0
Sunshine Hospital - Saint Albans
Recruitment hospital [12] 0 0
Liverpool Hospital - Nedlands
Recruitment hospital [13] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2109 - North Ryde
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [7] 0 0
7001 - Hobart
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
3000 - Melbourne
Recruitment postcode(s) [11] 0 0
3021 - Saint Albans
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Arizona
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California
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Texas
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Washington
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Austria
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Graz
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Linz
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Wien
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Charleroi
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Gent
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Leuven
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Liège
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Pleven
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Zagreb
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Patra
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Rome
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Incheon
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Seoul
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Suwon
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Manresa
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Switzerland
State/province [153] 0 0
Geneva
Country [154] 0 0
Switzerland
State/province [154] 0 0
Zurich
Country [155] 0 0
Taiwan
State/province [155] 0 0
Kaohsiung
Country [156] 0 0
Taiwan
State/province [156] 0 0
New Taipei City
Country [157] 0 0
Taiwan
State/province [157] 0 0
Puzi
Country [158] 0 0
Taiwan
State/province [158] 0 0
Taichung City
Country [159] 0 0
Taiwan
State/province [159] 0 0
Taichung
Country [160] 0 0
Taiwan
State/province [160] 0 0
Tainan
Country [161] 0 0
Taiwan
State/province [161] 0 0
Taipei City
Country [162] 0 0
Taiwan
State/province [162] 0 0
Taoyuan
Country [163] 0 0
Turkey
State/province [163] 0 0
Ankara
Country [164] 0 0
Turkey
State/province [164] 0 0
Edirne
Country [165] 0 0
Turkey
State/province [165] 0 0
Istanbul
Country [166] 0 0
Turkey
State/province [166] 0 0
Izmir
Country [167] 0 0
Turkey
State/province [167] 0 0
Mamak
Country [168] 0 0
Turkey
State/province [168] 0 0
Sisli
Country [169] 0 0
United Kingdom
State/province [169] 0 0
Birmingham
Country [170] 0 0
United Kingdom
State/province [170] 0 0
Dorchester
Country [171] 0 0
United Kingdom
State/province [171] 0 0
Glasgow
Country [172] 0 0
United Kingdom
State/province [172] 0 0
London
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Manchester
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Middlesex
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Oxford
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Port Talbot
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Preston
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Surrey
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04527991