Status:
ACTIVE_NOT_RECRUITING
Atezolizumab and BCG in High Risk BCG naïve Non-muscle Invasive Bladder Cancer (NMIBC) Patients (BladderGATE)
Lead Sponsor:
Fundacion Oncosur
Collaborating Sponsors:
Apices Soluciones S.L.
Conditions:
Invasive Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Patients with high-risk non-muscle invasive bladder cancer (NMIBC) are usually managed by transurethral resection of their bladder tumor (TURBT) alone plus additional intravesical therapy to deliver h...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years old.
- Signed Informed Consent Form
- Histologically confirmed diagnosis of high risk non-muscle-invasive (T1, high grade Ta - G3- and / or carcinoma in situ) transitional cell carcinoma of the bladder
- Never treated with BCG or stopped \>3y ago
- World Health Organization Performance Status (WHO PS) 0-1
- No prior radiation to bladder
- Life expectancy ≥ 5 years
- Adequate hematologic and end-organ function
- The time elapsed between the TURBT and the start of the study treatment will not be less than 4 weeks or more than 12 weeks
- Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 14 days prior to the first dose of study treatment.
- For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 150 days after the last dose of study drug.
- Tumor tissue biopsy at study entry or availability of an archival specimen obtained within 2 months of study screening
- Willingness to complete all study-related procedures including patient-reported questionnaires
Exclusion
- Muscle-invasive, locally advanced non-resectable, or metastatic urothelial carcinoma (i.e., T2, T3, T4, and/or stage IV)
- Previous BCG within a 3 years period
- Life expectancy \<5 years
- WHO PS 2, 3 or 4
- Known additional malignancy that is progressing or requires active treatment
- Active autoimmune disease that has required systemic treatment in the past 2 years
- Evidence of interstitial lung disease or active non-infectious pneumonitis
- Active infection requiring systemic therapy
- Pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial through 150 days after the last dose of study treatment.
- Prior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor
- Known human immunodeficiency virus (HIV)
- Known active Hepatitis B or C infection or tuberculosis
- Received a live virus vaccine within 30 days of planned start of study treatment
- Treatment with any approved anti-cancer therapy, including chemotherapy , radiation therapy , or hormonal 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
- Allergy or hypersensitivity to components of the atezolizumab or BCG formulation
- Prior allogeneic stem cell or solid organ transplantation
- History of idiopathic pulmonary fibrosis, organizing pneumonia , drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- Serum albumin \< 2.5 g/dL
- Severe infections within 4 weeks prior to the first dose of study treatment
- 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
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina
- 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
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- History of prior systemic BCG infection
Key Trial Info
Start Date :
February 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04134000
Start Date
February 3 2020
End Date
September 1 2024
Last Update
May 21 2024
Active Locations (1)
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1
Hospital 12 de Octubre
Madrid, Spain