← Back to Search

Pembrolizumab + Gemcitabine + Radiation for Bladder Cancer

Phase 2

Waitlist Available

Led By Arjun Balar, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication

Clinical stage T2-T4a, N0, M0 urothelial bladder cancer

Must not have

Has a known history of active TB (Bacillus Tuberculosis)

Has an active infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is to see if adding pembrolizumab to radiation and gemcitabine helps people with muscle-invasive urothelial cancer who are not candidates for or decline radical cystectomy.

Who is the study for?

This trial is for adults with muscle-invasive urothelial bladder cancer who can't have or don't want a radical cystectomy. They must be in good health, not pregnant, agree to use contraception, and provide consent. People with certain allergies, recent investigational drug use, major surgery recovery, specific syndromes like Guillain-Barre or Stevens-Johnson Syndrome, active infections or conditions that could affect the trial's outcome are excluded.

What is being tested?

The study tests if adding pembrolizumab (MK3475) to gemcitabine and radiation therapy improves outcomes for patients with bladder cancer who aren't undergoing surgery. Participants will receive these treatments concurrently to see how effective they are when combined.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation of organs including lungs (pneumonitis), liver problems, skin reactions; also possible are fatigue and infusion reactions. Gemcitabine can lead to blood cell count changes, infection risk increase, nausea and kidney issues.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am using two birth control methods or am not able to have children, and will continue for 120 days after the study.

Select...

My bladder cancer is at a specific stage but hasn't spread to lymph nodes or other parts.

Select...

I cannot or will not undergo major bladder surgery as advised by my cancer doctor.

Select...

I am 18 years old or older.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

Select...

I have an active tuberculosis infection.

Select...

I am currently being treated for an infection.

Select...

I have a history of inflammatory bowel disease or scleroderma.

Select...

I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

Select...

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

Select...

I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

Select...

I have a history of inflammatory bowel disease or scleroderma.

Select...

I have a history of or currently have non-infectious lung inflammation.

Select...

I have had radiation therapy to my pelvic area before.

Select...

I have been diagnosed with HIV.

Select...

I have had treatments like chemotherapy for bladder cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Two-year bladder-intact disease-free survival rate

Secondary study objectives

Complete response (CR) rate

Metastasis-free survival

Overall survival

+1 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

Systemic infection

Clostridium difficile colitis

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

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: Pembrolizumab, Gemcitabine, and RTExperimental Treatment4 Interventions

* Lead-in single dose Pembrolizumab 200 mg, intravenously (IV) * Transurethral Resection of Bladder Tumor (TURBT) at pre-RT (maximal) and completion of therapy (diagnostic) * External Beam Radiation Therapy (EBRT) - 52 Gy in 20 fractions over 4 weeks (1 fraction = 2.6 Gy) * Gemcitabine 27 mg/m\^2 IV twice weekly for 4 weeks concurrent with EBRT * Pembrolizumab 200 mg IV every 3 weeks for total 3 doses starting day 1 of EBRT

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Gemcitabine

2017

Completed Phase 3

~1920