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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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

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

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

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

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

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

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I am 18 years old or older.

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I am fully active or can carry out light work.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The proportion of patients who are disease-free

Secondary outcome measures

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%

Arthralgia

16%

Back pain

16%

Lipase increased

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

Dysgeusia

Dyspnoea

Alopecia

Haematuria

Osteoarthritis

Pain in extremity

Myalgia

Abdominal pain

Blood alkaline phosphatase increased

Blood creatinine increased

Dysuria

Insomnia

Actinic keratosis

Erythema

Vertigo

Hyperthyroidism

Blood creatine phosphokinase increased

Basal cell carcinoma

Pulmonary embolism

Cerebral haemorrhage

Chronic inflammatory demyelinating polyradiculoneuropathy

Small intestinal obstruction

Erysipelas

Encephalitis

Squamous cell carcinoma

Obstructive pancreatitis

Subileus

Squamous cell carcinoma of skin

Transitional cell carcinoma

Guillain-Barre syndrome

Loss of consciousness

Muscular weakness

Cerebrovascular accident

Empyema

Cellulitis

Pneumonia

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

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

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,935 Previous Clinical Trials

588,818 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,055,046 Total Patients Enrolled

Dean Bajorin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

10 Previous Clinical Trials

3,445 Total Patients Enrolled

Media Library

Bacillus Calmette-Guérin (BCG) (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03504163 — Phase 2

Bladder Cancer Research Study Groups: Exploratory cohort for high-grade non-muscle-invasive upper tract urothelial carcinoma, High Risk T1 Bladder Cancer Cohort

Bladder Cancer Clinical Trial 2023: Bacillus Calmette-Guérin (BCG) Highlights & Side Effects. Trial Name: NCT03504163 — Phase 2

Bacillus Calmette-Guérin (BCG) (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03504163 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widespread is the implementation of this experiment?

"Patients may be recruited from 8 different sites, including Memorial Sloan Kettering West Harrison (All Protocol Activities), located in New york City's borough of Queens; Montvale’s Memorial Sloan Kettering Bergen (All protocol activities); and the renowned Memorial Sloan Kettering Cancer Center (All Protocol Activities) in Manhattan. Additionally, there are 5 other trial locations available."

Answered by AI

Has Pembrolizumab (MK-3475) received governmental authorization?

"Due to the Phase 2 nature of this trial, Power's analysis concluded that Pembrolizumab (MK-3475) has a safety score of 2 as there is some evidence indicating its security but none attesting to its therapeutic effectiveness."

Answered by AI

Is enrollment for this clinical trial currently open?

"According to the data on clinicaltrials.gov, this medical experiment is currently recruiting trial participants. The original posting date was June 27th 2018 and it has been recently revised as of July 13th 2022."

Answered by AI

What illnesses has Pembrolizumab (MK-3475) been utilized to combat?

"Pembrolizumab (MK-3475) is a popular choice for patients with malignant neoplasms. Additionally, this drug can be useful in treating unresectable melanoma, microsatellite instability high conditions, and cases where chemotherapy has been unsuccessful at halting disease progression."

Answered by AI

What is the cumulative enrollment tally for this experiment?

"Affirmative. According to the records available on clinicaltrials.gov, this medical trial has been actively searching for participants since June 27th 2018 and was last updated July 13th 2022. Currently, 37 patients must be sourced from 8 healthcare centres."

Answered by AI

Could you elucidate on any prior research conducted pertaining to Pembrolizumab (MK-3475)?

"Currently, 961 trials are underway to assess the efficacy of Pembrolizumab (MK-3475). Of these studies, 122 are in Phase 3. Although Houston, Texas is home to the bulk of those investigations, there exist 35727 locations across the globe conducting research on this drug."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab (MK-3475) and Bacillus Calmette-Guérin (BCG) as First-Line Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer (NMIBC) and High-Grade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma (NMI-UTUC)]

2018. "Pembrolizumab (MK-3475) and Bacillus Calmette-Guérin (BCG) as First-Line Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer (NMIBC) and High-Grade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma (NMI-UTUC)]". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03504163.

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