Your session is about to expire
← Back to Search
Monoclonal Antibodies
Sacituzumab Govitecan-hziy for Urothelial Cancer (TROPiCS-04 Trial)
Phase 3
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Docetaxel will only be an option in TPC arm for Individuals meeting specific bilirubin and AST/ALT criteria.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3.5 years
Awards & highlights
TROPiCS-04 Trial Summary
This trial will compare the effects of sacituzumab govitecan-hziy versus TPC on overall survival in people with advanced UC.
Who is the study for?
This trial is for adults with advanced urothelial cancer that's spread or can't be surgically removed. They must have already tried a platinum-based treatment and immunotherapy, have good organ function, not be pregnant or breastfeeding, and agree to use birth control. People who've had certain other treatments or health conditions like active infections, second cancers, heart problems, or poor hearing are excluded.Check my eligibility
What is being tested?
The study tests Sacituzumab Govitecan-hziy against the physician's choice of Vinflunine, Paclitaxel, or Docetaxel in patients with advanced urothelial cancer. The main goal is to see if Sacituzumab Govitecan-hziy helps patients live longer compared to standard treatments.See study design
What are the potential side effects?
Sacituzumab Govitecan-hziy may cause nausea, diarrhea, hair loss (alopecia), fatigue and low blood cell counts which could lead to increased risk of infection. Other side effects include allergic reactions and potential liver issues.
TROPiCS-04 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for Docetaxel based on my liver function tests.
Select...
I am fully active or have some restrictions but can still care for myself.
Select...
My cancer returned or worsened after treatment with platinum and PD-1/PD-L1 therapy.
TROPiCS-04 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Clinical Benefit Rate (CBR) by BICR
Clinical Benefit Rate (CBR) by Investigator Assessment
Duration of Objective Tumor Response (DOR) by BICR
+10 moreTROPiCS-04 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sacituzumab Govitecan-hziyExperimental Treatment1 Intervention
Participants will receive 10 mg/kg of sacituzumab govitecan-hziy intravenously on Day 1 and Day 8 of 21-day cycles.
Group II: Treatment of Physician's ChoiceActive Control3 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab Govitecan-hziy
2019
Completed Phase 3
~550
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,081 Previous Clinical Trials
842,005 Total Patients Enrolled
1 Trials studying Urothelial Cancer
24 Patients Enrolled for Urothelial Cancer
Everest MedicinesIndustry Sponsor
3 Previous Clinical Trials
711 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,139 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate to severe hearing loss.I have moderate to severe numbness, pain, or weakness in my hands or feet.I am eligible for Docetaxel based on my liver function tests.I am allergic or cannot tolerate certain cancer drugs.I have active Hepatitis B or C.I was treated with carboplatin for advanced cancer because I couldn't take cisplatin.I have a current heart condition.My cancer is advanced or has spread and cannot be surgically removed, primarily affecting my urinary system.I agree to use birth control.I am not pregnant or breastfeeding.I have HIV with an undetectable viral load and take medication that could affect my treatment.I haven't had certain cancer treatments in the weeks before starting a new treatment cycle.I am fully active or have some restrictions but can still care for myself.I have had chemotherapy for bladder cancer with standard treatments.I have been treated with topoisomerase 1 inhibitors before.My cancer progressed after enfortumab vedotin treatment or I can't tolerate it.I am not pregnant and will follow the contraception guidelines.I am still experiencing side effects from my last chemotherapy.I have not had a GI perforation or active inflammatory bowel disease in the last 6 months.My blood counts are good without needing transfusions or growth support recently.My liver is working well.I have another type of cancer that is currently active.I am currently being treated for a serious infection.My brain metastases have been treated and are now stable.My cancer returned or worsened after treatment with platinum and PD-1/PD-L1 therapy.I have not counted carboplatin or anti PD-1/PD-L1 therapy as a line of treatment for eligibility.I was treated with carboplatin and anti PD-1/PD-L1 therapy for my advanced cancer because I couldn't receive cisplatin.My kidney function is reduced with a creatinine clearance below 60 mL/min.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment of Physician's Choice
- Group 2: Sacituzumab Govitecan-hziy
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are receiving care as part of this clinical investigation?
"The clinical trial is actively recruiting participants, with 696 people needed at 22 different sites. The trial was originally posted on 1/13/2021 and was last edited on 10/27/2022."
Answered by AI
Are there any toxic effects associated with Sacituzumab Govitecan-hziy?
"Sacituzumab Govitecan-hziy is in phase 3 clinical trials, thus there is some data affirming its efficacy and multiple rounds of data supporting safety, giving it a score of 3."
Answered by AI
What are the standard conditions that Sacituzumab Govitecan-hziy has been shown to be an effective treatment for?
"Sacituzumab Govitecan-hziy is a medication most commonly used to treat neoplasm metastasis. However, it has also shown efficacy in treating soft tissue sarcoma (sts), locally advanced non-small cell lung cancer, and metastatic bladder cancer."
Answered by AI
Is this the first time that Sacituzumab Govitecan-hziy has been studied?
"Presently, there are 1171 clinical trials involving Sacituzumab Govitecan-hziy underway, with 333 of them in Phase 3. While Shanghai, China has a concentration of these trials, they are taking place in 60255 locations globally."
Answered by AI
Are participants still being collected for this research project?
"This is an active clinical trial that is presently recruiting patients, according to the website clinicaltrials.gov. The study was originally posted on 1/13/2021 and was most recently updated on 10/27/2022."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Juravinski Hospital and Cancer Centre
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger