← Back to Search

Cancer Vaccine

Pembrolizumab + BCG for Bladder Cancer

Phase 2

Recruiting

Led By Dean Bajorin, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

No prior intravesical BCG therapy for patients in the T1 bladder cancer cohort

Histologically confirmed urothelial cancer by TURBT performed at MSK for patients in the T1 bladder cancer cohort or by high-grade cytology/biopsy by ureteroscopy performed at MSK for patients in the NMI-UTUC cohort

Must not have

Prior therapy with specific agents

Active infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether combining the immunotherapy drug pembrolizumab with the standard treatment of BCG will be more effective than BCG alone in treating bladder cancer.

Who is the study for?

Adults with high-risk T1 bladder cancer or upper tract urothelial carcinoma who haven't had BCG therapy, are not candidates for certain surgeries, and have no evidence of metastasis. They must be able to consent, use birth control if applicable, and meet specific health criteria. Exclusions include recent heart attacks, major surgery within the last month, pregnancy, inability to follow procedures, live vaccines recently taken or needed soon.

What is being tested?

The trial is testing pembrolizumab combined with BCG as a first-line treatment for patients with high-grade non-muscle-invasive bladder cancer at 'high risk' where BCG alone may fail. It aims to see if this combination can be an alternative to more invasive treatments like radical cystectomy.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs (like inflammation), infusion reactions from the drug entering the body, fatigue, potential complications in blood cells leading to disorders such as anemia or clotting issues and increased susceptibility to infections.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have T1 bladder cancer and have not had BCG therapy.

Select...

My bladder or urinary tract cancer was confirmed with specific tests at MSK.

Select...

I have refused surgery for my bladder or upper urinary tract cancer.

Select...

I am using two birth control methods or am not having sex to avoid pregnancy during and up to 120 days after the study.

Select...

My recent scans show no signs of cancer spread or muscle invasion.

Select...

I have not had radiation for bladder cancer but may have had it for prostate cancer.

Select...

I am 18 years old or older.

Select...

I am fully active or can carry out light work.

Exclusion Criteria

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

Select...

I have previously been treated with specific medications.

Select...

I am currently being treated for an infection.

Select...

I have been diagnosed with HIV.

Select...

I have or had bladder cancer that has grown into the bladder muscle or cancer that has invaded the prostate tissue.

Select...

I have unstable chest pain.

Select...

My heart condition limits my physical activity.

Select...

I have not had major surgery in the last 28 days, except for TURBT or ureteroscopy.

Select...

I have an active Hepatitis B or C infection.

Select...

I have an autoimmune disease that needed treatment recently or is severe.

Select...

I have not received any live vaccines in the last 30 days and agree not to during the study.

Select...

I have a serious wound or broken bone that is not healing.

Select...

My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The proportion of patients who are disease-free

Secondary study objectives

The proportion of patients who remain free from high-grade recurrence

Side effects data

From 2024 Phase 3 trial • 55 Patients • NCT03783078

25%

Fatigue

22%

Pruritus

22%

Aspartate aminotransferase increased

20%

Asthenia

18%

Alanine aminotransferase increased

16%

Lipase increased

16%

Arthralgia

16%

Back pain

16%

Constipation

15%

Anaemia

15%

Nausea

13%

Weight decreased

13%

Diarrhoea

13%

Pyrexia

11%

Headache

Decreased appetite

Eczema

Dry mouth

Vomiting

Oedema peripheral

Amylase increased

Rash

Myalgia

Osteoarthritis

Pain in extremity

Dysgeusia

Haematuria

Dyspnoea

Alopecia

Abdominal pain

Blood alkaline phosphatase increased

Blood creatinine increased

Insomnia

Dysuria

Actinic keratosis

Erythema

Vertigo

Hyperthyroidism

Blood creatine phosphokinase increased

Basal cell carcinoma

Pulmonary embolism

Obstructive pancreatitis

Small intestinal obstruction

Subileus

Cellulitis

Empyema

Encephalitis

Erysipelas

Pneumonia

Muscular weakness

Squamous cell carcinoma

Squamous cell carcinoma of skin

Transitional cell carcinoma

Cerebral haemorrhage

Cerebrovascular accident

Chronic inflammatory demyelinating polyradiculoneuropathy

Guillain-Barre syndrome

Loss of consciousness

Colitis

Dysphagia

Respiratory syncytial virus infection

Upper respiratory tract infection

Wound infection

Parkinson's disease

Acute kidney injury

Dyspnoea exertional

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab 200 mg

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: High Risk T1 Bladder Cancer CohortExperimental Treatment2 Interventions

Pts will receive pembrolizumab/MK-3475 after transurethral resection of bladder tumor/TURBT in comb w/BCG as initial therapy. Pembrolizumab (MK-3475) will be administered as a 400 mg IV infusion at 6-wk intervals for 9 doses over a 48-wk period, unless there is unacceptable toxicity or other reasons to discontinue treatment occur. Intravesical BCG therapy (TICE strain, 50 mg) will be given 1x-weekly for 6 consecutive wks as a standard induction course, followed by maintenance BCG consistent w/standard clinical practice. BCG will start on wk 3 after the first infusion of pembrolizumab (400 mg) to allow for initial priming of T cells to further enhance the effects of BCG treatment.

Group II: Exploratory cohort for high-grade non-muscle-invasive upper tract urothelial carcinomaExperimental Treatment2 Interventions

Pts will receive pembrolizumab (MK-3475) administered after ureteroscopy/laser ablation in comb w/BCG as initial therapy. Pembrolizumab (MK-3475) will be administered as 400 mg IV infusion at 6-week intervals for 9 doses over a 48-week period, unless there is unacceptable toxicity or other reasons that would warrant the discontinuation of treatment. Pts will receive once-weekly BCG therapy (TICE strain, 50 mg) for 6 consecutive wks as a standard induction course administered through a percutaneous nephrostomy tube in antegrade fashion for patients with high-grade NMI-UTUC, consistent with standard clinical practice. BCG will start on wk 3 after the first infusion of pembrolizumab (400 mg) to allow for initial priming of T cells to further enhance the effects of BCG treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bacillus Calmette-Guérin (BCG)

2014

Completed Phase 2

~1980

Pembrolizumab (MK-3475)

2019

Completed Phase 3

~240