An Experimental Treatment With Pembrolizumab in Treating Patients With Advanced Bladder Cancer

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"This study will use MK-3475 to stimulate your immune system to treat muscle-invasive bladder cancer."
Age: 18 years or older
Healthy Volunteers: No
Keywords: Urothelial Carcinoma, bladder cancer
Type: Drug study, Phase 3
789 Participants
You are being asked to take part in this study because you have had surgery to remove bladder cancer. Your cancer is in the deep muscle of the bladder wall (called muscle-invasive bladder cancer). Patients who are not in a study are usually followed with scans without treatment. They may also receive chemotherapy with a combination of drugs. Cisplatin-combination chemotherapy before surgery is the standard of care if you have normal kidney function. It has been shown to improve survival in patients. If you did not get chemotherapy before surgery it can be given after surgery (also called adjuvant chemotherapy). Studies have shown adjuvant chemotherapy may lengthen the time it takes for the disease to come back. However, it does not improve survival in patients like yourself.

The purpose of this study is to compare any good and bad effects of using a drug called MK- 3475 (pembrolizumab). It will be used after the removal of your muscle invasive bladder cancer. MK-3475 is a drug that uses a person’s own immune system to treat cancer. This study will allow researchers to know whether treatment with MK-3475 is better, the same, or worse than the usual approach. To be better, the MK-3475 should increase life by 9 months or more, compared to observation alone. The use of MK-3475 could prevent your cancer from returning but it could also cause side effects. This immunotherapy drug, MK-3475, is already FDA-approved for use in other types of cancers. It is considered experimental for your type of cancer.
This study requires

This study has two study groups.

If you are in Group 1 you will receive treatment with MK- 3475. The MK-3475 will be given through your vein over 30 minutes once every 3 weeks. If you are in Group 2 you will be followed with scans without treatment. You will not receive any treatment but you will be contacted every 3 weeks with a phone call from your doctor’s office to see how you are feeling. You will also be asked to come back to the clinic every 6 weeks for a check-up for one year.

A computer will by chance assign you to one of the 2 groups in this study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the others. You will have an equal chance of being placed in either group. Prior to randomization, a sample of your tumor tissue will be sent to a laboratory to determine if it contains a protein called PD-L1. This test is required because they will help the investigators determine who will be most likely to respond to this treatment in the future. In addition, it will ensure that the 2 groups are equal. The results of the PD-L1 will not be shared with you or your physician.

Who can participate

Inclusion Criteria:

  • Histologically confirmed muscle-invasive urothelial carcinoma of the bladder or upper tract; variant histology allowed as long as urothelial carcinoma is predominant (> 50%); pure small-cell carcinoma is excluded
  • Paraffin tissue samples obtained by transurethral resection of muscle-invasive bladder tumor, upper tract resection, cystectomy/nephrectomy/ureterectomy, or nephroureterectomy must be available; this specimen submission is mandatory prior to registration as results will be used for stratification
  • Patient must fit into one of the following three categories:
  • Patients who received neoadjuvant chemotherapy and pathologic stage at surgical resection is >= pT2 and/or N+ OR
  • Patients who are not cisplatin-eligible (according to >= 1 of the following criteria: - - Eastern Cooperative Oncology Group [ECOG] performance status of 2, creatinine clearance < 60 mL/min, grade >= 2 hearing loss, grade >= 2 neuropathy, or New York Heart Association class III heart failure and pathologic stage at surgical resection is >= pT3 or pN+) OR
  • Patients that decline adjuvant cisplatin-based or other systemic chemotherapy based on an informed discussion with the physician and pathologic stage at surgical resection is >= pT3 or pN+
  • Patient must have had radical surgical resection of their bladder cancer >= 4 weeks but =< 16 weeks prior to pre-registration
  • No invasive cancer at the surgical margins
  • No evidence of residual cancer or metastasis after surgery
  • No metastatic disease on cross-sectional imaging (according to Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1 criteria)
  • No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease; human immunodeficiency virus (HIV) (+) patients are eligible as long as they have: cd4 > 200, undetectable viral load and on highly active antiretroviral therapy (HAART) therapy
  • No current pneumonitis or prior history of non-infectious pneumonitis that required steroids within the previous 5 years
  • Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible
  • Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
  • No known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
  • No postoperative/adjuvant systemic therapy
  • No prior treatment with any therapy on the PD-1/PD-L1 axis
  • No treatment with any other type of investigational agent =< 4 weeks before pre-registration
  • No major surgery =< 4 weeks before pre-registration
  • No radiation therapy =< 4 weeks before pre-registration
  • No neoadjuvant chemotherapy =< 4 weeks before pre-registration
  • Not pregnant and not nursing
  • ECOG performance status =< 2
  • Absolute neutrophil count (ANC) >= 1,200/mm^3
  • Leukocytes >= 3,000/ mm^3
  • Platelet count >= 75,000/mm^3
  • Hemoglobin >= 9 g/dL or >= 5.6 mmol/L
  • Creatinine =< 2.0 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 30 mL/min
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x upper limit of normal (ULN)
  • Serum albumin >= 2.8 g/dL
  • For women of childbearing potential only: a negative urine or serum pregnancy test done =< 7 days prior to pre-registration is required
  • Results of central PD-L1 testing available; Q2 Solutions will forward the PD-L1 results to the statistical center and the statistical center will notify the site that the result is available; the notification from the Alliance registration/randomization office will serve as a confirmation of this eligibility criteria; after sites receive the confirmation e-mail from Alliance they can register the patient
Benefits and risks of participating

We cannot promise any benefit to you as a result of taking part in this research study.


As with any research study, there are risks - both known and unknown. The study doctor will discuss the known risks associated with taking part in this research study. The study team will inform you of any new information as it becomes known to them.
You will not be paid for taking part in this research study.
Study duration and period
If you are in Group 1 you will receive MK-3475 once every 3 weeks for one year. After you finish one year of treatment, your doctor will continue to watch you for a total of five years after you were registered to this study. You will need to be seen every 3 months for the first 3 years and then every 6 months for the next 2 years. If you are in Group 2 you will not receive treatment and your doctor’s office will call you every 3 weeks to check on you. You will also be asked to come into the clinic every 6 weeks for a check-up for the first year after you are put onto the study. After that first year you will be seen every 3 months for the first 3 years and then every 6 months for the next 2 years.
Recruitment period
From Jan. 30, 2018
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Christina Devisser
Research Topic
  • Stage II Bladder Urothelial Carcinoma AJCC v6 and v7
  • Stage III Bladder Urothelial Carcinoma AJCC v6 and v7

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