A Study to Test the Safety of Immunotherapy With Nivolumab Alone or With Ipilimumab Before Surgery for Bladder Cancer Patients Who Are Not Suitable for Chemotherapy

  • End date
    Jan 24, 2024
  • participants needed
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 24 March 2022
radical cystectomy
neutrophil count
bladder cancer
transitional cell carcinoma
bladder tumor
bladder carcinoma
surgery for bladder cancer


The purpose of this study is to test if immunotherapy with nivolumab alone or in combination with ipilimumab is safe and does not delay the planned bladder cancer surgery. The investigators want to see if treatment with these drugs prior to surgery may decrease the size of the bladder cancer and thus could help make the surgery more successful.

Condition Bladder Cancer
Treatment Ipilimumab, Nivolumab, Radical Cystectomy
Clinical Study IdentifierNCT03520491
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on24 March 2022


Yes No Not Sure

Inclusion Criteria

Histologically confirmed diagnosis of urothelial carcinoma of the bladder. Variant histology is acceptable if there is a predominant urothelial component
Patients ineligible for cisplatin based on any of the following criteria
° Cystoscopically and radiographically confirmed cT2-4a cN0 cM0 disease
Patients with cT4a disease invading into the prostatic stroma with no
Grade 2 or above audiometric hearing loss (per CTCAE v4.0)
cystoscopic confirmation of muscle invasion are eligible
Grade 2 or above peripheral neuropathy (per CTCAE v4.0)
°Histologically confirmed high grade urothelial carcinoma of the upper tract
and/or radiographically visible tumor stage T2-T4a N0/x M0 disease with
Medically appropriate candidate for radical cystectomy, as per MSK Attending Urologic Oncologist
positive selective urinary cytology. Hydronephrosis associated with tumor on
imaging or biopsy will be considered invasive by definition. (Variant
Required initial laboratory values
histology is acceptable if there is a predominant urothelial component)
Estimated or calculated creatinine clearance ≥ 30ml/min but < 60 ml/min
Availability of tumor specimen block or 30 unstained slides from diagnosis of
muscle-invasive disease. Patients with fewer than 30 slides available may be
enrolled after discussion with the Principal Investigator
Karnofsky performance status ≥ 70%
Age ≥ 18 years
Absolute neutrophil count ≥ 1.5 x 10^9/L
Platelets ≥ 100 x 10^9/L
Bilirubin ≤1.5 times the upper limit of normal (x ULN)
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
PTT/PT ≤1.5 x ULN or INR < 1.7 x ULN for patients who are not receiving therapeutic anticoagulation. Patients receiving therapeutic anticoagulation should be on a stable dose

Exclusion Criteria

Presence of active autoimmune disease, symptoms, or conditions, with the following
Prior treatment with systemic chemotherapy for urothelial cancer, including immune checkpoint inhibitors for non-muscle invasive bladder cancer. (Prior intravesical treatment such as BCG is allowed.)
Prior bladder-directed radiotherapy (exclusion applies only to MIBC Cohorts 1 - 3)
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
°Subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune
thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo
Serious, non-healing wound, ulcer, or bone fracture
psoriasis, or alopecia) not requiring systemic treatment, asymptomatic laboratory
evidence of autoimmune disease (e.g.: +ANA, +RF, anti-thyroglobulin antibodies), or
conditions not expected to recur in the absence of an external trigger are permitted
Prior therapy with intravesical BCG within 6 weeks of treatment
to enroll
Subjects with a condition requiring systemic treatment with either corticosteroids
(>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14
days of first dose of study drug. Inhaled or topical steroids, and adrenal replacement
steroid doses are permitted in the absence of active autoimmune disease
Evidence of bleeding diathesis or coagulopathy. Therapeutic anticoagulation is
permitted, but patients must be on a stable dose
Inability to comply with study and/or follow-up procedures
Major surgical procedure within 28 days prior to the study. (Transurethral resection
of bladder tumor is permitted
Other prior malignancy active within the previous 2 years except for local or
organ-confined early stage cancer that has been definitively treated with curative
intent or does not require treatment, does not require ongoing treatment, has no
evidence of active disease, and has a negligible risk of recurrence and is therefore
unlikely to interfere with the endpoints of the study
Subjects who have received prior therapy with any T cell co-stimulation or checkpoint
pathways such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-CD137; or other
medicines specifically targeting T cells are prohibited. Prior IL-2 is permitted
Positive test for hepatitis B virus (HBV) using HBV surface antigen (HBV sAg) test or
positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV
antibody test indicating acute or chronic infection
Known history of testing positive for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS)
History of allergy to study drug component or history of severe hypersensitivity
reaction to any monoclonal antibody
Women who are breastfeeding or pregnant as evidenced by a positive pregnancy test
within 14 days of first dose
Male subjects who are unwilling to use contraception during the treatment and for at
least 31 weeks after the last dose of study treatment (5 half-lives of study drug plus
days duration of sperm turnover)
Women of childbearing potential (WOCBP) not using a medically acceptable means of
contraception throughout the study treatment and for at least 23 weeks following the
last dose of study treatment (5 half-lives of study drug plus 30 days duration of
ovulatory cycle)
WOCBP are defined as those who have experienced menarche and who have not
undergone successful surgical sterilization (hysterectomy, bilateral tubal
ligation, or bilateral oophorectomy) or are not postmenopausal. Post-menopausal
is defined as
Amenorrhea ≥ 12 consecutive months without another cause, or
For women with irregular menstrual periods and on hormone replacement therapy
(HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL
Subjects who are compulsorily detained for treatment of either a psychiatric or
physical (e.g., infectious disease) illness
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