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Monoclonal Antibodies

Pembrolizumab + Enfortumab Vedotin + Surgery for Bladder Cancer

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

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

Must have

Clinically nonmetastatic bladder cancer determined by imaging

ECOG performance status of 0, 1, or 2

Must not have

Has uncontrolled diabetes

Received any prior radiotherapy to the bladder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 6.75 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying a combination of two drugs, pembrolizumab and enfortumab vedotin, given together with surgery in people with bladder cancer that has spread to nearby muscle.

Who is the study for?

This trial is for adults with muscle-invasive bladder cancer who can't take cisplatin or choose not to. They must be able to undergo surgery, have good organ function, and an ECOG status of 0-2. Women must use effective contraception or abstain from sex if they're of childbearing potential; men also have similar requirements if receiving enfortumab vedotin.

What is being tested?

The study tests perioperative pembrolizumab (a drug) alone or combined with enfortumab vedotin (another drug), plus bladder removal surgery against surgery alone. The goal is to see which approach leads to better survival without the disease progressing.

What are the potential side effects?

Pembrolizumab may cause immune system-related side effects, infusion reactions, fatigue, skin issues, and complications in organs like lungs and intestines. Enfortumab Vedotin could lead to nerve damage, eye problems like dry eyes or inflammation, blood sugar changes, and tiredness.

Eligibility Criteria

Inclusion Criteria

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

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My bladder cancer has not spread, as confirmed by scans.

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I can take care of myself and am up and about more than half of my waking hours.

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My bladder cancer is confirmed and mostly urothelial type.

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I am eligible and agree to undergo surgery to remove my bladder and nearby lymph nodes for cancer treatment.

Exclusion Criteria

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

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My diabetes is not under control.

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I have had radiation therapy to my bladder before.

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I have received a transplant from another person.

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I have had pneumonitis treated with steroids or have it now.

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I have been treated with drugs targeting immune checkpoints.

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I have moderate to severe numbness, tingling, or muscle weakness.

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I have had treatments like chemotherapy or radiation for bladder cancer.

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I am currently on medication for an infection.

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I haven't needed systemic therapy for an autoimmune disease in the last 2 years.

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I have had cancer treatment or been in a cancer study within the last 3 years.

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I had surgery to remove bladder cancer that was not invading the muscle.

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My cancer has spread to nearby lymph nodes or other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 6.75 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 6.75 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 6.75 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

Upper arm

Secondary study objectives

Disease-Free Survival (DFS)

Upper arm

Number of Participants Discontinuing Study Drug Due to Adverse Events (AEs)

+8 more

Awards & Highlights

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.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm C: Enfortumab Vedotin + Pembrolizumab + SurgeryExperimental Treatment1 Intervention

Participants receive 3 preoperative cycles of enfortumab vedotin + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative enfortumab vedotin + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.

Group II: Arm A: Pembrolizumab + SurgeryExperimental Treatment2 Interventions

Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.

Group III: Arm B: Surgery aloneActive Control1 Intervention

Participants receive standard of care surgery alone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

0 / 16Eligibility criteria met