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Alkylating agents

Pembrolizumab + Chemoradiotherapy 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

Has a histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology

Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Must not have

Has an active autoimmune disease that has required systemic treatment in the past 2 years

Has a history of non-infectious pneumonitis that required steroids or has current pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 1 year

Awards & highlights

Pivotal Trial

Summary

This trial will compare the effectiveness of a new cancer treatment (pembrolizumab + chemoradiotherapy) to the current standard of care (chemoradiotherapy alone) for people with muscle-invasive bladder cancer.

Who is the study for?

This trial is for adults with muscle-invasive bladder cancer who are set to receive chemoradiotherapy and meet certain health criteria, including good organ function and performance status. Women must not be pregnant or breastfeeding and follow specific contraceptive guidelines; men must agree to use contraception or abstain from heterosexual intercourse.

What is being tested?

The study tests the effectiveness of pembrolizumab (a type of immunotherapy) combined with chemoradiotherapy versus just chemoradiotherapy in treating bladder cancer. The goal is to see if adding pembrolizumab improves survival without the cancer spreading or worsening.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs, infusion reactions, fatigue, skin rash, digestive issues like diarrhea, liver problems, hormone gland issues (like thyroid), and can increase infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My bladder cancer was confirmed to be invasive and mainly urothelial.

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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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I am scheduled for chemoradiotherapy with a specific chemotherapy plan.

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My bladder cancer has not spread to other parts of my body.

Exclusion Criteria

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

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I have an autoimmune disease treated with medication in the last 2 years.

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I have had or currently have lung inflammation treated with steroids.

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I have received treatment with specific medications before.

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I have received an organ or tissue transplant from another person.

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My bladder cancer is widespread but not invasive.

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I have swelling in both kidneys due to urine buildup.

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I am currently being treated for an infection with medication.

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I have an active tuberculosis infection.

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I have had radiation or cancer treatment for bladder cancer.

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I have a history of hepatitis B or an active hepatitis C infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Bladder Intact Event-Free Survival (BI-EFS)

Secondary study objectives

Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30

Change from Baseline in Urinary, Bowel, and Sexual Domains of the Bladder Cancer Index (BCI)

Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

+11 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pembrolizumab + Chemotherapy + RadiotherapyExperimental Treatment8 Interventions

Participants receive pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.

Group II: Placebo + Chemotherapy + RadiotherapyPlacebo Group8 Interventions

Participants receive placebo to pembrolizumab plus one of three chemotherapy regimens chosen by investigator, plus one of three radiotherapy regimens chosen by investigator.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Cisplatin

2013

Completed Phase 3

~3120