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Monoclonal Antibodies

Sacituzumab Govitecan for Bladder Cancer (TROPHY U-01 Trial)

Phase 2

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1

Individuals with histologically confirmed urothelial cancer (UC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose date up to last dose date plus 30 days (approximately 3 years)

Awards & highlights

TROPHY U-01 Trial Summary

This trial is testing a new drug for people with metastatic urothelial cancer. The drug will be given alone and with other drugs to see if it is effective and safe.

Who is the study for?

Adults with advanced urothelial cancer, who have specific treatment histories and performance status. They must have adequate organ function and a life expectancy of at least 3 months. Pregnant or lactating women, individuals with active second cancers, certain recent treatments, autoimmune diseases requiring systemic treatment in the past two years, known hepatitis B/C infection or CNS metastases are excluded.Check my eligibility

What is being tested?

The trial is testing Sacituzumab Govitecan alone and combined with other drugs like Domvanalimab and Pembrolizumab for effectiveness and safety in treating metastatic urothelial cancer. Participants will be grouped based on their previous treatments to receive these therapies.See study design

What are the potential side effects?

Potential side effects include reactions to monoclonal antibodies (like infusion reactions), impact on blood cells leading to increased risk of infections or bleeding, liver or kidney function changes, fatigue, nausea, neuropathy (nerve issues), as well as potential autoimmune responses.

TROPHY U-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is confirmed to be urothelial cancer.

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My blood counts are healthy without needing transfusions.

TROPHY U-01 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose date up to last dose date plus 30 days (approximately 3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose date up to last dose date plus 30 days (approximately 3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose date up to last dose date plus 30 days (approximately 3 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

Progression free survival (PFS) based on central review by RECIST 1.1 criteria (Cohort 5 only)

Secondary outcome measures

Clinical Benefit Rate (CBR)

Therapeutic procedure

Cohorts 3, 4, and 5: Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities

+4 more

TROPHY U-01 Trial Design

12Treatment groups

Experimental Treatment

Group I: Cohort 6 (Arm 4): Carboplatin + GemcitabineExperimental Treatment3 Interventions

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.

Group II: Cohort 6 (Arm 3): Sacituzumab Govitecan-hziy + ZIM + DomvanalimabExperimental Treatment3 Interventions

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.

Group III: Cohort 6 (Arm 2): Sacituzumab Govitecan-hziy + ZIMExperimental Treatment2 Interventions

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.

Group IV: Cohort 6 (Arm 1): Sacituzumab Govitecan-hziyExperimental Treatment1 Intervention

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.

Group V: Cohort 5 (Arm 3): ZIMExperimental Treatment1 Intervention

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.

Group VI: Cohort 5 (Arm 2): AvelumabExperimental Treatment1 Intervention

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 Q2W until PD, unacceptable toxicity, or loss of clinical benefit.

Group VII: Cohort 5 (Arm 1): Sacituzumab Govitecan-hziy + ZIMExperimental Treatment2 Interventions

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, 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.

Group VIII: Cohort 4: Sacituzumab Govitecan-hziy + Cisplatin + Zimberelimab (Dose Expansion Phase)Experimental Treatment3 Interventions

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).

Group IX: Cohort 4: Sacituzumab Govitecan-hziy + Cisplatin + Avelumab (Dose Escalation Phase)Experimental Treatment3 Interventions

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.

Group X: Cohort 3: Sacituzumab Govitecan-hziy + PembrolizumabExperimental Treatment2 Interventions

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 sacituzumab govitecan-hziy 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 sacituzumab govitecan-hziy may be tested based on dose-limiting toxicities (DLTs) observed to determine the Recommended Phase 2 Dose (RP2D) of sacituzumab govitecan-hziy in combination with pembrolizumab.

Group XI: Cohort 2: Sacituzumab Govitecan-hziyExperimental Treatment1 Intervention

Participants with UC who are ineligible for platinum-based therapy and failed therapy with previous immune CPI therapy will receive sacituzumab govitecan-hziy 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle.

Group XII: Cohort 1: Sacituzumab Govitecan-hziyExperimental Treatment1 Intervention

Participants with urothelial cancer (UC) previously treated with platinum-based and/or checkpoint inhibitors (CPIs) will receive sacituzumab govitecan-hziy 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sacituzumab Govitecan-hziy

2019

Completed Phase 3

~550

Pembrolizumab

2017

Completed Phase 2

~2010

Cisplatin

2013

Completed Phase 3

~1940

Avelumab

2018

Completed Phase 2

~2450

Zimberelimab

2018

Completed Phase 1

~50

Carboplatin

2014

Completed Phase 3

~6670

Gemcitabine

2017

Completed Phase 3

~2070

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck KGaA, Darmstadt, GermanyIndustry Sponsor

436 Previous Clinical Trials

114,013 Total Patients Enrolled

Gilead SciencesLead Sponsor

1,082 Previous Clinical Trials

842,056 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,050 Total Patients Enrolled

Media Library

Sacituzumab Govitecan-hziy (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03547973 — Phase 2

Sacituzumab Govitecan-hziy (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03547973 — Phase 2

Bladder Cancer Clinical Trial 2023: Sacituzumab Govitecan-hziy Highlights & Side Effects. Trial Name: NCT03547973 — Phase 2

Bladder Cancer Research Study Groups: Cohort 5 (Arm 2): Avelumab, Cohort 4: Sacituzumab Govitecan-hziy + Cisplatin + Avelumab (Dose Escalation Phase), Cohort 4: Sacituzumab Govitecan-hziy + Cisplatin + Zimberelimab (Dose Expansion Phase), Cohort 5 (Arm 3): ZIM, Cohort 6 (Arm 1): Sacituzumab Govitecan-hziy, Cohort 5 (Arm 1): Sacituzumab Govitecan-hziy + ZIM, Cohort 6 (Arm 2): Sacituzumab Govitecan-hziy + ZIM, Cohort 1: Sacituzumab Govitecan-hziy, Cohort 2: Sacituzumab Govitecan-hziy, Cohort 3: Sacituzumab Govitecan-hziy + Pembrolizumab, Cohort 6 (Arm 3): Sacituzumab Govitecan-hziy + ZIM + Domvanalimab, Cohort 6 (Arm 4): Carboplatin + Gemcitabine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Cisplatin been cleared by the FDA for medical use?

"Cisplatin has received a score of 2. This is because, although there is some data attesting to its safety, there are currently no studies that show it to be an effective medication."

Answered by AI

Are patients currently being accepted for this particular clinical trial?

"That is correct. The website clinicaltrials.gov has information showing that this trial is still recruiting patients. The study was created on 8/13/2018, and the last update was on 11/7/2022. They are looking for 643 total participants from 30 different locations."

Answered by AI

How many people are recruited for this experiment?

"Yes, the latest information on clinicaltrials.gov says that this trial is presently recruiting patients. This study was initially posted on 8/13/2018 and was most recently updated on 11/7/2022. They are looking for 643 participants between 30 sites."

Answered by AI

For what purposes is Cisplatin commonly employed?

"Cisplatin, while principally used to treat malignant neoplasms, can also be employed against other conditions like unresectable melanoma and microsatellite instability high."

Answered by AI

Could you list any other research that has utilized Cisplatin?

"Cisplatin was first studied in 1997 and, as of now, there have been a total of 1786 completed clinical trials. Additionally, there are currently 1747 live clinical trials with many taking place in Chicago, Illinois."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

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

Tagawa, Scott T., Arjun V. Balar, Daniel P. Petrylak, Arash Rezazadeh Kalebasty, Yohann Loriot, Aude Fléchon, Rohit K. Jain, et al.. 2021. “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”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.03489.

clinicaltrials.govStudy

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

2018. "Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03547973.