Pembrolizumab (MK-3475) as First-line Therapy for High Risk T1 Non-Muscle-Invasive Bladder Cancer

  • End date
    Apr 15, 2022
  • participants needed
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 15 May 2021
neutrophil count
carcinoma in situ
bladder cancer
invasive bladder cancer
transurethral resection
bladder tumor


The purpose of this study is to find out what effects, good and/or bad, pembrolizumab has on the participant and urothelial cancer.

Condition urinary tract neoplasm, bladder cancer, bladder disorder, Urothelial Cancer, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, carcinoma of the bladder, bladder tumor
Treatment pembrolizumab (MK-3475)
Clinical Study IdentifierNCT03504163
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on15 May 2021


Yes No Not Sure

Inclusion Criteria

Be willing and able to provide written informed consent/assent for the trial
Histologically confirmed urothelial cancer by TURBT performed at MSKCC
TURBT within 6 weeks of protocol entry with complete resection of all papillary lesions
Patients with high risk, BCG-nave non-muscle-invasive urothelial cancer defined as having one of the following disease states
T1 on restaging biopsy, plus cis
Multiple ( 1) T1 recurrences, plus cis
Multifocal T1 plus cis
T1b, plus cis
T1 with lymphovascular invasion plus cis
Patient refusal of cystectomy and bilateral pelvic lymphadenectomy
No prior intravesical therapy
No prior radiation therapy for bladder cancer. Prior radiation therapy for prostate cancer is allowed
ECOG performance status 0 or 1
Age 18 years of age
Female subjects of childbearing potential should be willing to use 2 methods of birth control, be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of the study medication (reference section 9.5.2). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >1 year
Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
Patients must not have other invasive malignancies within the past 5 years (with the exception of non-melanoma skin cancers, localized prostate cancer, and carcinoma in situ of the cervix)
Required Initial Laboratory Values
Absolute neutrophil count 1.5 x 10E9/L
Platelets 100 x 10E9/L
Hemoglobin 9 g/dL
Bilirubin 1.5 times the upper limit of normal (x ULN)
Aspartate transaminase (AST) and alanine transaminase (ALT) 3.0 x ULN
Calculated creatinine clearance 30 using the CKD-Epi formula

Exclusion Criteria

Prior treatment with systemic chemotherapy
Unstable angina
New York Heart Association (NYHA) Grade II or greater congestive heart failure
History of myocardial infarction within 6 months
History of stroke within 6 months
Evidence of bleeding diathesis or coagulopathy
Presence of any systemic metastases (ie, nodal, visceral, or central nervous system)
Major surgical procedure (other than TURBT) within 28 days prior to the study
Pregnant (positive pregnancy test) or lactating
Serious, non-healing wound, ulcer, or bone fracture
Inability to comply with study and/or follow-up procedures
Prior therapy with an anti-PD-1 agent, anti-PD-L1 agent, or other inhibitory or stimulatory agent oriented towards a T-cell receptor
Active infection requiring systemic therapy
Known history of human immunodeficiency virus (HIV)
Known active Hepatitis B or Hepatitis C
Received live attenuated vaccines within 30 days prior to start of study treatment. Patients must also agree to avoid live attenuated vaccines during study treatment
Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic or immunosuppressive agents. Subjects with vitiligo, diabetes Type I, or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjgren's syndrome will not be excluded from the study
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