Back to Clinical Trials

Brief Title: Study of Sacituzumab Govitecan (IMMU-132) in Metastatic or Locally Advanced Unresectable Urothelial Cancer

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 (TROPiCS-04)

INTRODUCTION

  • Org Study ID: IMMU-132-13
  • Secondary ID: 2020-002964-29
  • NTC ID: NCT04527991
  • Sponsor: Gilead Sciences

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).

  • Overall Status
    Recruiting
  • Start Date
    January 13, 2021
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Overall Survival (OS)

Primary Outcome 1 - Timeframe: Up to 3.5 years

CONDITION

  • Locally Advanced or Metastatic Unresectable Urothelial Cancer

ELIGIBILITY

Inclusion Criteria:
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.

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

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

- 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.

- 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.

- Male individuals must agree to use an adequate method of contraception starting with the first dose of study therapy through 3 months after the last dose of study therapy.
Exclusion Criteria:
Females who are pregnant or lactating.

- 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.

- Have received prior chemotherapy for UC with all 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 an approved therapy).
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.

- Have previously received topoisomerase 1 inhibitors.
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.
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%. - Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal (GI) perforation within 6 months of enrollment. - Have an active serious infection requiring anti-infective therapy (Contact medical monitor for clarification). - Have known history of Human Immunodeficiency Virus (HIV)-1/2 with undetectable viral load and on medications that may interfere with SN-38 metabolism. - 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. - 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. - 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. - Have inability to complete all specified study procedures for any reason.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Gilead Study Director

Role: Study Director

Affiliation: Gilead Sciences

Overall Contact

Name: Gilead Study Director

Phone: 1-833-445-3230(GILEAD-0)

Email: GileadClinicalTrials@gilead.com

LOCATION

Facility Status Contact
Facility: UCLA Hematology/ Oncology
Los Angeles, California 90095
United States
Status: Recruiting Contact: N/A
Facility: University of California Irvine (UCIMC)
Orange, California 92868
United States
Status: Recruiting Contact: N/A
Facility: MedStar Washington Hospital Center
Washington, District of Columbia 20010
United States
Status: Recruiting Contact: N/A
Facility: Baptist MD Anderson Cancer Center
Jacksonville, Florida 32207
United States
Status: Recruiting Contact: N/A
Facility: Boca Raton Clinical Research Global USA - Plantation
Plantation, Florida 33322
United States
Status: Recruiting Contact: N/A
Facility: University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United States
Status: Recruiting Contact: N/A
Facility: University of Maryland School of Medicine
Baltimore, Maryland 21201
United States
Status: Recruiting Contact: N/A
Facility: Montefiore Medical Center
Bronx, New York 10467
United States
Status: Recruiting Contact: N/A
Facility: Weill Cornell Medical College
New York, New York 10065
United States
Status: Recruiting Contact: N/A
Facility: Cleveland Clinic
Cleveland, Ohio 44195
United States
Status: Recruiting Contact: N/A
Facility: Oklahoma Cancer Specialists and Research Institute (OCSRI)
Tulsa, Oklahoma 74104
United States
Status: Recruiting Contact: N/A
Facility: Thompson Oncology Group - Knoxville Downtown
Knoxville, Tennessee 37916
United States
Status: Recruiting Contact: N/A
Facility: University Cancer Specialists - Knoxville
Knoxville, Tennessee 37920
United States
Status: Recruiting Contact: N/A
Facility: Center for Cancer and Blood Disorders
Fort Worth, Texas 76104
United States
Status: Recruiting Contact: N/A
Facility: Summit Cancer Centers
Spokane, Washington 99208
United States
Status: Recruiting Contact: N/A
Facility: Ashford Cancer Centre Research - ICON Cancer Centre Adelaide
Kurralta Park, South Australia 5037
Australia
Status: Recruiting Contact: N/A
Facility: Az Maria Middelares Ghent
Gent, 9000
Belgium
Status: Recruiting Contact: N/A
Facility: Juravinski Hospital and Cancer Centre
Hamilton, L8V 5C2
Canada
Status: Recruiting Contact: N/A
Facility: Princess Margaret Cancer Centre
Toronto, M5G 2M9
Canada
Status: Recruiting Contact: N/A
Facility: British Columbia Cancer Agency-Vancouver Centre
Vancouver, V5Z 4E6
Canada
Status: Recruiting Contact: N/A
Facility: Beijing Cancer Hospital
Beijing, 100142
China
Status: Recruiting Contact: N/A
Facility: CHU Saint Andre
Bordeaux, 33075
France
Status: Recruiting Contact: N/A
Facility: Centre Hospitalier Universitaire de Nimes
Nimes, 30029
France
Status: Recruiting Contact: N/A
Facility: Institut Gustave Roussy
Villejuif Cedex, 94805
France
Status: Recruiting Contact: N/A
Facility: Institut Für Versorgungsforschung in Der Onkologie
Koblenz, 56068
Germany
Status: Recruiting Contact: N/A
Facility: BRCR Medical Center, Inc
San Juan, 00907
Puerto Rico
Status: Recruiting Contact: N/A
Facility: Hospital Clinic de Barcelona
Barcelona, 8036
Spain
Status: Recruiting Contact: N/A
Facility: MD Anderson Cancer Center
Madrid, 28033
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Ramon y Cajal
Madrid, 28034
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Sant Joan de Déu de Manresa
Manresa, 08243
Spain
Status: Recruiting Contact: N/A
Facility: Clinica Universidad de Navarra
Pamplona, 31008
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Virgen del Rocio
Sevilla, 41013
Spain
Status: Recruiting Contact: N/A
Facility: Barts Health NHS Trust
London, EC1A 7BE
United Kingdom
Status: Recruiting Contact: N/A