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Monoclonal Antibodies

Sacituzumab Govitecan + Enfortumab Vedotin for Bladder Cancer

Phase 1

Waitlist Available

Led By Bradley A McGregor, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Patients must have received prior treatment with platinum containing therapy defined as within the adjuvant/neoadjuvant setting with recurrent or progressive disease within 12 months or receiving treatment with platinum in locally advanced or metastatic setting.

ECOG performance status 0-1.

Must not have

Have active cardiac disease, defined as: Myocardial infarction or unstable angina pectoris within 6 months prior to 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, New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of < 40%

Uncontrolled tumor related bone pain or impending spinal cord compression.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will study what doses of these drugs can be safely combined and given to people with mUC.

Who is the study for?

Adults with advanced urothelial carcinoma who've had platinum-based therapy and a checkpoint inhibitor treatment can join. They must have good organ function, no active infections or serious heart conditions, not be pregnant or breastfeeding, and agree to use contraception.

What is being tested?

The trial is testing the safe combination doses of two drugs: Sacituzumab Govitecan (SG) and Enfortumab Vedotin (EV), for treating metastatic urothelial carcinoma. It aims to find out how these drugs work together.

What are the potential side effects?

Potential side effects include allergic reactions to drug components, liver issues reflected in blood tests, possible impact on fertility and pregnancy outcomes, fatigue from anemia due to low red blood cells count.

Eligibility Criteria

Inclusion Criteria

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

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I've had platinum-based treatment for cancer that came back or worsened within a year.

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I am fully active or can carry out light work.

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

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My cancer can be measured on scans and has grown in previously treated areas.

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I am using two birth control methods or am not having sex if I can have children.

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My cancer is mainly urothelial carcinoma but may have other cell types, except small-cell carcinoma.

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My cancer cannot be removed with surgery.

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My blood and organ functions are within the required ranges for the trial.

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I am 18 years old or older.

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My hepatitis B virus load is undetectable with treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart condition.

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I have severe pain from my cancer spreading to my bones or risk of it affecting my spine.

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I do not have active inflammatory bowel disease or recent GI perforation.

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I don't have severe side effects from previous cancer treatments.

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I have been treated with topoisomerase 1 inhibitors, SG, or EV before.

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I am not pregnant or breastfeeding.

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I am not allergic to any components similar to those in the trial drug.

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My diabetes is not under control, with an A1C level above 7% and symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting toxicity (DLT) of Sacituzumab Govitecan (SG) and Enfortumab Vedotin in combination

Maximum Tolerated Dose (MTD) of Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV) in Combination

Secondary study objectives

Objective response rate (ORR)

Overall survival (OS) Rate

Rate of Complete Responses (CR)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV),Experimental Treatment2 Interventions

Participants will be given the study drugs Enfortumab Vedotin and then Sacituzumab Govitecan on Days 1 and 8 of a 21-day study cycle. Dose escalation and de-escalation for the Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV) combination will be guided using the Bayesian optimal interval (BOIN) design with up to 4 dose level escalations.

0 / 18Eligibility criteria met