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Monoclonal Antibodies

Sacituzumab + Enfortumab With/Without Pembrolizumab for Bladder Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

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

Must have

PART 1 ONLY: Participants must not have received more than 2 lines of therapy for la/mUC. Platinum-based chemotherapy followed by avelumab maintenance is considered 2 lines of therapy

Must have histologically documented, locally advanced/metastatic urothelial carcinoma (la/mUC)

Must not have

Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)

Known additional malignancy that is progressing or has required active treatment within the past 3 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is a sub-study of a larger study called KEYMAKER-U04. It will have two parts. The first part will look at how safe and effective a combination of sacituz

Who is the study for?

This trial is for adults with advanced urothelial carcinoma, a type of bladder cancer. Participants should not have had certain previous treatments and must be in good physical condition to handle the study drugs. Specific criteria will determine who can join based on their medical history and current health status.

What is being tested?

The study tests Sacituzumab Tirumotecan plus Enfortumab Vedotin (EV), with or without Pembrolizumab, for treating advanced bladder cancer. It's divided into two parts: first assessing safety and early results, then evaluating effectiveness and side effects when combined with Pembrolizumab.

What are the potential side effects?

Possible side effects include reactions at the injection site, fatigue, nausea, lowered blood cell counts increasing infection risk, potential liver or kidney issues, and allergic responses to the medication components.

Eligibility Criteria

Inclusion Criteria

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

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I have had no more than 2 treatments for my bladder cancer.

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My cancer is an advanced bladder cancer confirmed by a biopsy.

Exclusion Criteria

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

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I have or had inflammatory bowel disease like Crohn's or ulcerative colitis.

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I have another cancer that is getting worse or was treated in the last 3 years.

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I have cancer that has spread to my brain or surrounding membranes.

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I have a severe eye condition that affects my cornea or eyelids.

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I have diabetes that is not well-controlled.

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I have not had a live vaccine in the last 30 days.

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I have or had lung inflammation that needed steroids.

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I am currently being treated for an infection.

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I am still recovering from major surgery or have complications.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part 1: Percentage of Participants Who Discontinued Study Treatment Due to an AE

Part 1: Percentage of Participants Who Experienced At Least One Adverse Event (AE)

Part 1: Percentage of Participants with Dose-limiting toxicities (DLT)

+4 more

Secondary study objectives

Part 1: Cmax of Enfortumab Vedotin-ADC

Part 1: Cmax of Free Payload for Enfortumab Vedotin

Part 1: Cmax of Free Payload for Sacituzumab Tirumotecan

+24 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sacituzumab tirumotecan plus EV and pembrolizumabExperimental Treatment3 Interventions

Participants will receive sacituzumab tirumotecan as an IV infusion and EV as an IV infusion on Days 1 and 8 of every 3-week cycle until disease progression, intolerable toxicity, or investigator decision. Participants will also receive pembrolizumab 200 mg as an IV infusion on Day 1 of every 3-week cycle for up to \~2 years (35 cycles).

Group II: Sacituzumab tirumotecan plus EVExperimental Treatment2 Interventions

Participants will receive sacituzumab tirumotecan as an intravenous (IV) infusion and EV as an IV infusion on Days 1 and 8 of every 3-week cycle until disease progression, intolerable toxicity, or investigator decision.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

0 / 12Eligibility criteria met