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

  • STATUS
    Recruiting
  • End date
    Apr 15, 2022
  • participants needed
    37
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 15 May 2021
cancer
carcinoma
neutrophil count
lymphadenectomy
pembrolizumab
carcinoma in situ
bladder cancer
invasive bladder cancer
transurethral resection
bladder tumor

Summary

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

Details
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

Eligibility

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note