Trials by Condition
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 accepting patients for this trial.
Lead Sponsor:
Hoffmann-La Roche
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
(=) 2;
- 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
- 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
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Denise Haas
650-736-1252
Recruiting