Trial Search Results

Safety and Pharmacology Study of Atezolizumab Alone and in Combination With Bacille Calmette-Guérin (BCG) in High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Participants

The purpose of this study is to test the safety of the study drug Atezolizumab, when given alone and in combination with different dose levels of BCG and to find out what effects, good or bad, the study drug, alone and in combination with Bacille Calmette-Guérin (BCG), has on you. Atezolizumab is a drug that acts by blocking a protein called PD-L1. Blocking this protein may improve the body’s immune system and allow for better recognition and killing of cancer cells. BCG is a type of bacteria that is put directly into the bladder. BCG stimulates the body's immune system cells, which can destroy cancer cells in the bladder.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Hoffmann-La Roche

Stanford Investigator(s):

Intervention(s):

  • Drug: Atezolizumab
  • Biological: Bacille Calmette-Guérin

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Histologically confirmed non-muscle-invasive transitional cell carcinoma (TCC) of the
   bladder with carcinoma in-situ (CIS)

   - High-risk NMIBC defined by the following:

BCG-unresponsive NMIBC:

Persistence of high-grade CIS at 6 months following an adequate course of BCG; or
Stage/grade progression at 3 months after induction BCG; or Recurrence of high-grade CIS
after achieving a disease-free state (i.e., CR) following induction of an adequate course
of BCG that occurs less than (<) 6 months after the last exposure to BCG

BCG-relapsing NMIBC:

Recurrence of high-grade CIS after achieving a disease-free state following induction of an
adequate course of BCG that occurs greater than or equal to (>/=) 6 months after the last
exposure to BCG

Very high-risk (VHR) BCG-naïve NMIBC:

VHR NMIBC, defined as having at least 1 of the following: Multiple and/or large (greater
than [>] 3 centimeters [cm]) T1, (HG/G3) tumors; T1, (HG/G3) tumor with concurrent CIS; T1,
G3 with CIS in prostatic urethra; Micropapillary variant of non-muscle invasive urothelial
carcinoma

   - For BCG-unresponsive and BCG-relapsing NMIBC, participants must have received an
   adequate course of BCG

   - Resection of all pTa/pT1 papillary disease

   - No prior radiation to bladder or pelvic region

   - Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to
   (
   - Life expectancy >/=12 weeks

   - Adequate hematologic and end-organ function

   - Creatinine clearance >/=30 milliliters per minute (mL/min) (calculated using the
   Cockcroft-Gault formula)

   - For women of childbearing potential: agreement to remain abstinent (refrain from
   heterosexual intercourse) or use contraceptive methods that result in a failure rate
   of <1% per year during the treatment period and for at least 5 months after the last
   dose of study drug. Women must refrain from donating eggs during this same period.

   - For men receiving BCG: Agreement to remain abstinent (refrain from sexual intercourse)
   or use a condom

   - Tumor tissue biopsy within 60 days prior to study entry or availability of an archival
   specimen obtained within 60 days of study screening

Exclusion Criteria:

   - Evidence of locally advanced, metastatic, muscle-invasive, and/or extravesical bladder
   cancer

   - Any malignancy within 5 years prior to Cycle 1, Day 1

   - History of autoimmune disease, idiopathic pulmonary fibrosis, organizing pneumonia
   (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or
   active pneumonitis

   - Signs or symptoms of infection within 2 weeks prior to the first dose of study
   treatment

   - Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to the first
   dose of study treatment

   - Treatment with any approved anti-cancer therapy within 3 weeks prior to the first dose
   of study treatment

   - Treatment with any other investigational agent or participation in another clinical
   trial with therapeutic intent within 4 weeks prior to the first dose of study
   treatment

   - Pregnant or lactating women, or women intending to become pregnant during the study

   - Prior allogeneic stem cell or solid organ transplantation

   - Positive test for human immunodeficiency virus (HIV)

   - Active hepatitis B or C and/or tuberculosis

   - Severe infections within 28 days prior to the first dose of study treatment

   - Significant cardiovascular disease

   - Major surgical procedure other than for diagnosis within 4 weeks prior to the first
   dose of study treatment, or anticipation of need for a major surgical procedure during
   the course of the study

   - Administration of a live/attenuated vaccine within 4 weeks prior to the first dose of
   study treatment, within 5 months following the administration of the last dose of
   study drug, or anticipation that such a live/attenuated vaccine will be required
   during the study

   - History of prior significant toxicity or intolerance to BCG requiring discontinuation
   of treatment

   - History of prior systemic BCG infection

   - History of immunosuppression, or conditions associated with congenital or acquired
   immune deficiency

   - Concurrent febrile illness, urinary tract infection, or gross hematuria

   - Prior treatment with cluster of differentiation 137 (CD137) agonists or immune
   checkpoint blockade therapies

   - Treatment with systemic immunostimulatory agents within 6 weeks or five half-lives of
   the drug, whichever is shorter, prior to the first dose of study treatment

   - Treatment with systemic immunosuppressive medications within 2 weeks prior to the
   first dose of study treatment, or anticipated requirement for systemic
   immunosuppressive medications during the trial

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting