Sacituzumab Govitecan + Enfortumab Vedotin for Bladder Cancer

Recruiting in Palo Alto (17 mi)

Overseen byBradley A McGregor, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This research study will assess what doses of Sacituzumab Govitecan and Enfortumab Vedotin can be safely combined in the treatment of metastatic urothelial carcinoma (mUC). The names of the study drugs in this investigational combination are: * Enfortumab Vedotin * Sacituzumab Govitecan

Research Team

Bradley A McGregor, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document.

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

The effects of SG and EV on the developing human fetus are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of SG administration.

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Exclusion Criteria

Participants with psychiatric illness/social situations that would limit compliance with study requirements.

I have a serious heart condition.

Participants who are receiving any other investigational agents.

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Treatment Details

Interventions

Enfortumab Vedotin (Monoclonal Antibodies)
Sacituzumab Govitecan (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.