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Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients (ALBAN)

Primary Purpose

Bladder Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BCG
Atezolizumab
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed informed consent form after the last endoscopic surgery (TURBT)
  2. Adult man and women ( age ≥18 years)
  3. Any high risk non muscle invasive urothelial carcinoma histologically confirmed (mixed histology tumors allowed if urothelial carcinoma histology is predominant) defined on the TURBT as any of the following :

    • T1 tumor and/or
    • High grade (WHO 2004) and/or
    • Grade 3 (WHO1973) and/or
    • Carcinoma in situ (CIS)
  4. Tumor tissue available from the surgery for central confirmation of the diagnosis and analysis the expression of PD-L1
  5. At least one additional (second) resection of the primary tumor has been performed in any of the following cases [without upstaging towards Muscle Invasive Bladder Cancer (EAU guidelines, 2017)] :

    • T1 tumors at physician's discretion,
    • incomplete initial TURB,
    • no muscle in the specimen (can be omitted if TaLG/G1 tumors or primary CIS only was found)
  6. Absence of metastasis in pelvis, abdomen, or chest, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan no more than 90 days prior to the first study treatment
  7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
  8. Life expectancy ≥12 weeks
  9. Systolic blood pressure (BP) <160 mmHg and diastolic BP <95 mmHg, as documented within 7 days prior to the first study treatment (hypertension allowed provided it is controlled)
  10. Adequate hematologic and end-organ function, as defined by the following laboratory results obtained within 7 days prior to the first study treatment:

    • absolute neutrophil count (ANC) ≥1500 cells/μL
    • white blood cell (WBC) counts >2500/μL
    • Lymphocyte count ≥300/μL
    • Platelet count ≥100,000/μL
    • Hemoglobin ≥9.0 g/dL
    • aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), and alkaline phosphatase ≤2.5 × the upper limit of normal (ULN)
    • Serum bilirubin ≤1.0 × ULN Patients with known Gilbert disease who have serum bilirubin level ≤3 × ULN may be enrolled.
    • Partial thromboplastin time (PTT)/Prothrombin Time (PT) ≤1.5 × ULN or international normalized ratio (INR) <1.7 × ULN
    • Calculated creatinine clearance ≥20 mL/min (Cockcroft-Gault formula)
  11. 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 atezolizumab
  12. Patients affiliated to the social security system
  13. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.

Exclusion Criteria:

  1. Patient having received previous BCG therapy for bladder cancer
  2. Any approved anti-cancer therapy, including systemic chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment. Hormone-replacement therapy or oral contraceptives are allowed
  3. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug, whichever is longer, prior to day 1 of study treatment
  4. Malignancies other than urothelial cancer within 5 years prior to Day 1 of cycle 1 of treatment except the following:

    • Patients with localized low risk prostate cancer (defined as Stage ≤T2b, Gleason score ≤7, and PSA at prostate cancer diagnosis ≤20 ng/mL [if measured]) treated with curative intent (radiotherapy and/or prostatectomy) and without prostate-specific antigen (PSA) recurrence are eligible.
    • Patients with low risk prostate cancer (defined as Stage T1/T2a, Gleason score ≤7 and PSA ≤10 ng/mL) who are treatment-naive and undergoing active surveillance are eligible.
    • Patients with malignancies of a negligible risk of metastasis or death (e.g., risk of metastasis or death <5% at 5 years) are eligible provided they meet all of the following criteria: malignancy treated with expected curative intent (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) and no evidence of recurrence or metastasis by follow-up imaging and any disease-specific tumor markers.
  5. Pregnancy or breastfeeding
  6. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  7. Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  8. History of autoimmune disease or history of immunosuppression, or conditions associated with congenital or acquired immune deficiency , including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis (see Appendix 6 for a more comprehensive list of autoimmune diseases)

    • Patients with a history of autoimmune-related hypothyroidism/hyperthyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.
    • Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.
    • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan may be eligible.
    • History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  9. Serum albumin <2.5 g/dL
  10. Known HIV infection
  11. Patients with active hepatitis B virus (HBV; chronic or acute; defined as having a positive hepatitis B surface antigen (HBsAg) test prior the randomisation) or hepatitis C.

    • Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody (HBc Ab) and absence of HBsAg) are eligible. HBV DNA must be obtained in these patients prior to randomisation.
    • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  12. Known active tuberculosis
  13. Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  14. Signs or symptoms of urinary infection and/or other signs and symptoms > grade 1 (NCI CTCAE v5.0) within 2 weeks prior to Cycle 1, Day 1

    • Patients receiving therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1 are not eligible
    • Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or to prevent chronic obstructive pulmonary disease exacerbation) are eligible.
  15. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months before Cycle1, Day 1, unstable arrhythmias, or unstable angina.

    - Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.

  16. Major surgical procedure other than for diagnosis within 4 weeks prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
  17. Prior allogeneic stem cell or solid organ transplant
  18. Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation if such a live, attenuated vaccine will be required during the study

    - Influenza vaccination should be given during influenza season only (approximately October through May in the Northern Hemisphere and approximately April through September in the Southern Hemisphere). Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Cycle 1, Day 1, at randomization, during treatment or within 5 months following the last dose of atezolizumab (for patients randomized to atezolizumab).

  19. Any other disease, 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
  20. Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  21. Treatment with systemic immunostimulatory agents (including but not limited to interferons, interleukin 2 (IL-2)) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1
  22. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF) agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial

    • Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea, multiple doses for contrast allergy) may be enrolled in the study.
    • The use of inhaled or low-dose (e.g., ≤10 mg/day prednisone) corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, mineralocorticoids (e.g., fludrocortisone for adrenal insufficiency) and low-dose corticosteroids for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
  23. Person deprived of their liberty or under protective custody or guardianship

Sites / Locations

  • Groupe Jolimont - Hôpital de Jolimont
  • AZ Delta - Campus RumbekeRecruiting
  • Centre Hospitalier Universitaire AngersRecruiting
  • Centre Hospitalier Universitaire BordeauxRecruiting
  • Hôpital G. MontpiedRecruiting
  • Clinique Claude BernardRecruiting
  • CHU GrenobleRecruiting
  • Hôpital privé Toulon - Sainte MargueriteRecruiting
  • Hôpital du Kremlin-BicêtreRecruiting
  • Hôpital Saint VincentRecruiting
  • Hôpital privé de la LouvièreRecruiting
  • Hôpital Saint PhilibertRecruiting
  • Insitut Paoli CalmetteRecruiting
  • Centre Hospitalier Universitaire MarseilleRecruiting
  • Centre Hospitalier Universitaire NîmesRecruiting
  • Hôpital européen Georges PompidouRecruiting
  • Hôpital Saint LouisRecruiting
  • Groupe Hospitalier Paris Saint JosephRecruiting
  • Hôpital CochinRecruiting
  • Institut Mutualiste MontsourisRecruiting
  • Centre Hospitalier Universitaire TenonRecruiting
  • Hôpital Diaconesses- Croix Saint SimonRecruiting
  • Hôpital La Pitié SalpétrièreRecruiting
  • Centre Hospitalier Universitaire Lyon SudRecruiting
  • Centre CARIO-HPCARecruiting
  • Centre Hospitalier Universitaire RennesRecruiting
  • Hôpitaux d'instruction des armées BeginRecruiting
  • Hôpital FochRecruiting
  • Hôpitaux Leman
  • Institut Claudius RegaudRecruiting
  • Centre Hospitalier Universitaire ToursRecruiting
  • Institut Gustave RoussyRecruiting
  • Hospital Universitario A Coruña
  • Hospital Universitario de Jerez de la FronteraRecruiting
  • Hospital Universitario Ramon y CajalRecruiting
  • Hospital Universitario La Paz
  • Hospital General Universitario Morales Meseguer
  • Hospital Universitario de Canarias

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A : control arm

Arm B: experimental arm

Arm Description

BCG therapy only BCG therapy will be administered in two phases: induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1) maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1).

BCG therapy + administration of atezolizumab BCG therapy will be administered in two phases: induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1) maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1). atezolizumab is administered by IV infusion every 3 weeks (21 [± 2] days) for 1 year (18 cycles as a maximum).

Outcomes

Primary Outcome Measures

Recurrence-free survival
Recurrence is defined as reappearance of disease (local recurrence or occurrence of any metastasis) after the start of therapy.

Secondary Outcome Measures

Progression-free survival
Progression- free survival defined as the time from randomization to the date of disease progression defined as increase of stage from Ta to T1 or from CIS to T1; progression to Muscle Invasive Bladder Cancer (T≥ 2) or to lymph node N+ or to distant disease M+; the date of progression being determined by the endoscopic resection (TURBT) for a local relapse or by CT scan in case of non-local relapse.
Disease-specific survival
Disease-specific survival defined as the time from randomization to the date of death from bladder cancer.
Overall Survival
Overall Survival defined as the time from randomization to the date of death from any cause.
Disease worsening in each arm
Disease worsening, defined as cystectomy or change in therapy indicative, including systemic chemotherapy or radiation therapy. The date of diagnosis (cystoscopy or CT scan) leading to cystectomy or chemotherapy will be considered as the time of disease worsening.
Complete response in each arm
Complete response is assessed by cystoscopy and cytology.
Complete response among patients with CIS
Complete response is assessed by cystoscopy and cytology.
National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
The frequency, nature, and severity of adverse events graded according to NCI CTCAE v5.0 and according to the immune-related adverse event (irAE).
Quality of life questionnaire (QLQ): QLQ-C30 questionnaire (EORTC)
This self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

Full Information

First Posted
January 8, 2019
Last Updated
May 24, 2022
Sponsor
UNICANCER
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03799835
Brief Title
Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients
Acronym
ALBAN
Official Title
An Open Label, Randomized, Phase III Trial, Evaluating Efficacy of Atezolizumab in Addition to One Year BCG (Bacillus CaLmette-Guerin) Bladder Instillation in BCG-naive Patients With High-risk Non-muscle Invasive Bladder cANcer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
February 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER
Collaborators
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an open-label, randomized, multicentric study in patients with high-risk non-muscle invasive bladder cancer who had never received BCG for this disease. The objective is to evaluate the efficacy of atezolizumab as measured by recurrence-free survival.
Detailed Description
ALBAN study will randomize 516 patients in 45 centers in Europe (France, Belgium and Spain), according to a ratio 1:1 in the following arms of treatment: Arm A (control arm): BCG only Arm B (experimental arm): BCG+ atezolizumab The are two factors of stratifications (center and CIS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
516 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A : control arm
Arm Type
Active Comparator
Arm Description
BCG therapy only BCG therapy will be administered in two phases: induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1) maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1).
Arm Title
Arm B: experimental arm
Arm Type
Experimental
Arm Description
BCG therapy + administration of atezolizumab BCG therapy will be administered in two phases: induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1) maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1). atezolizumab is administered by IV infusion every 3 weeks (21 [± 2] days) for 1 year (18 cycles as a maximum).
Intervention Type
Drug
Intervention Name(s)
BCG
Other Intervention Name(s)
Bacillus Calmette Guerin (BCG) Medac®, OncoTice
Intervention Description
Intravesical administration OncoTice wil be used only under two conditions : BCG Medac® unavailable and the patient has received at minimum one instillation of BCG Medac®
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
MPDL3280A, Tecentriq®
Intervention Description
IV perfusion
Primary Outcome Measure Information:
Title
Recurrence-free survival
Description
Recurrence is defined as reappearance of disease (local recurrence or occurrence of any metastasis) after the start of therapy.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Progression- free survival defined as the time from randomization to the date of disease progression defined as increase of stage from Ta to T1 or from CIS to T1; progression to Muscle Invasive Bladder Cancer (T≥ 2) or to lymph node N+ or to distant disease M+; the date of progression being determined by the endoscopic resection (TURBT) for a local relapse or by CT scan in case of non-local relapse.
Time Frame
From randomization to the date of progression, assessed up to 5 years
Title
Disease-specific survival
Description
Disease-specific survival defined as the time from randomization to the date of death from bladder cancer.
Time Frame
From randomization to the date of death, assessed up to 5 years
Title
Overall Survival
Description
Overall Survival defined as the time from randomization to the date of death from any cause.
Time Frame
From randomization to the date of death, assessed up to 5 years
Title
Disease worsening in each arm
Description
Disease worsening, defined as cystectomy or change in therapy indicative, including systemic chemotherapy or radiation therapy. The date of diagnosis (cystoscopy or CT scan) leading to cystectomy or chemotherapy will be considered as the time of disease worsening.
Time Frame
From randomization to the date of death, assessed up to 5 years
Title
Complete response in each arm
Description
Complete response is assessed by cystoscopy and cytology.
Time Frame
6 weeks and 2 years after randomization
Title
Complete response among patients with CIS
Description
Complete response is assessed by cystoscopy and cytology.
Time Frame
6 weeks and 2 years after randomization
Title
National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Description
The frequency, nature, and severity of adverse events graded according to NCI CTCAE v5.0 and according to the immune-related adverse event (irAE).
Time Frame
Throughout study completion, assessed up to 5 years
Title
Quality of life questionnaire (QLQ): QLQ-C30 questionnaire (EORTC)
Description
This self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Time Frame
At randomization, every 12 weeks for years 1 and 2 after randomization, then every 24 weeks for years 3 to 5 after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent form after the last endoscopic surgery (TURBT) Adult man and women ( age ≥18 years) Any high risk non muscle invasive urothelial carcinoma histologically confirmed (mixed histology tumors allowed if urothelial carcinoma histology is predominant) defined on the TURBT as any of the following : T1 tumor and/or High grade (WHO 2004) and/or Grade 3 (WHO1973) and/or Carcinoma in situ (CIS) Tumor tissue available from the surgery for central confirmation of the diagnosis and analysis the expression of PD-L1 At least one additional (second) resection of the primary tumor has been performed in any of the following cases [without upstaging towards Muscle Invasive Bladder Cancer (EAU guidelines, 2017)] : T1 tumors at physician's discretion, incomplete initial TURB, no muscle in the specimen (can be omitted if TaLG/G1 tumors or primary CIS only was found) Absence of metastasis in pelvis, abdomen, or chest, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan no more than 90 days prior to the first study treatment Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 Life expectancy ≥12 weeks Systolic blood pressure (BP) <160 mmHg and diastolic BP <95 mmHg, as documented within 7 days prior to the first study treatment (hypertension allowed provided it is controlled) Adequate hematologic and end-organ function, as defined by the following laboratory results obtained within 7 days prior to the first study treatment: absolute neutrophil count (ANC) ≥1500 cells/μL white blood cell (WBC) counts >2500/μL Lymphocyte count ≥300/μL Platelet count ≥100,000/μL Hemoglobin ≥9.0 g/dL aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), and alkaline phosphatase ≤2.5 × the upper limit of normal (ULN) Serum bilirubin ≤1.0 × ULN Patients with known Gilbert disease who have serum bilirubin level ≤3 × ULN may be enrolled. Partial thromboplastin time (PTT)/Prothrombin Time (PT) ≤1.5 × ULN or international normalized ratio (INR) <1.7 × ULN Calculated creatinine clearance ≥20 mL/min (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 atezolizumab Patients affiliated to the social security system Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up. Exclusion Criteria: Patient having received previous BCG therapy for bladder cancer Any approved anti-cancer therapy, including systemic chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment. Hormone-replacement therapy or oral contraceptives are allowed Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug, whichever is longer, prior to day 1 of study treatment Malignancies other than urothelial cancer within 5 years prior to Day 1 of cycle 1 of treatment except the following: Patients with localized low risk prostate cancer (defined as Stage ≤T2b, Gleason score ≤7, and PSA at prostate cancer diagnosis ≤20 ng/mL [if measured]) treated with curative intent (radiotherapy and/or prostatectomy) and without prostate-specific antigen (PSA) recurrence are eligible. Patients with low risk prostate cancer (defined as Stage T1/T2a, Gleason score ≤7 and PSA ≤10 ng/mL) who are treatment-naive and undergoing active surveillance are eligible. Patients with malignancies of a negligible risk of metastasis or death (e.g., risk of metastasis or death <5% at 5 years) are eligible provided they meet all of the following criteria: malignancy treated with expected curative intent (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) and no evidence of recurrence or metastasis by follow-up imaging and any disease-specific tumor markers. Pregnancy or breastfeeding History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation History of autoimmune disease or history of immunosuppression, or conditions associated with congenital or acquired immune deficiency , including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis (see Appendix 6 for a more comprehensive list of autoimmune diseases) Patients with a history of autoimmune-related hypothyroidism/hyperthyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan may be eligible. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. Serum albumin <2.5 g/dL Known HIV infection Patients with active hepatitis B virus (HBV; chronic or acute; defined as having a positive hepatitis B surface antigen (HBsAg) test prior the randomisation) or hepatitis C. Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody (HBc Ab) and absence of HBsAg) are eligible. HBV DNA must be obtained in these patients prior to randomisation. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Known active tuberculosis Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia Signs or symptoms of urinary infection and/or other signs and symptoms > grade 1 (NCI CTCAE v5.0) within 2 weeks prior to Cycle 1, Day 1 Patients receiving therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1 are not eligible Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or to prevent chronic obstructive pulmonary disease exacerbation) are eligible. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months before Cycle1, Day 1, unstable arrhythmias, or unstable angina. - Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate. Major surgical procedure other than for diagnosis within 4 weeks prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study Prior allogeneic stem cell or solid organ transplant Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation if such a live, attenuated vaccine will be required during the study - Influenza vaccination should be given during influenza season only (approximately October through May in the Northern Hemisphere and approximately April through September in the Southern Hemisphere). Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Cycle 1, Day 1, at randomization, during treatment or within 5 months following the last dose of atezolizumab (for patients randomized to atezolizumab). Any other disease, 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 Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies Treatment with systemic immunostimulatory agents (including but not limited to interferons, interleukin 2 (IL-2)) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1 Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF) agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea, multiple doses for contrast allergy) may be enrolled in the study. The use of inhaled or low-dose (e.g., ≤10 mg/day prednisone) corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, mineralocorticoids (e.g., fludrocortisone for adrenal insufficiency) and low-dose corticosteroids for patients with orthostatic hypotension or adrenocortical insufficiency is allowed. Person deprived of their liberty or under protective custody or guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soazig Nénan-Le Ficher
Phone
+33185343113
Email
s-nenan@unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Maggy Chausson
Phone
+33185343112
Ext
+33185343112
Email
m-chausson@unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morgan Roupret, MD-PHD
Organizational Affiliation
Hôpital Pitié-Salpétrière
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yohann Loriot, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Jolimont - Hôpital de Jolimont
City
Haine Saint Paul
ZIP/Postal Code
7100
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
AZ Delta - Campus Rumbeke
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lieven Goeman, MD
Facility Name
Centre Hospitalier Universitaire Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Souhil Lebdai, MD
First Name & Middle Initial & Last Name & Degree
MD
Facility Name
Centre Hospitalier Universitaire Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégoire Robert, MD
First Name & Middle Initial & Last Name & Degree
Marine Gross-Goupil, MD
Facility Name
Hôpital G. Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Guy, MD
First Name & Middle Initial & Last Name & Degree
MD
Facility Name
Clinique Claude Bernard
City
Ermont
ZIP/Postal Code
95120
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Thomas, MD
First Name & Middle Initial & Last Name & Degree
Julie Giroud, MD
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Luc Descotes, MD-PHD
First Name & Middle Initial & Last Name & Degree
Mathieu Laramas, MD
Facility Name
Hôpital privé Toulon - Sainte Marguerite
City
Hyères
ZIP/Postal Code
83400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mael Martin, MD
First Name & Middle Initial & Last Name & Degree
Philippe Bernard, MD
Facility Name
Hôpital du Kremlin-Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Irani, MD
Facility Name
Hôpital Saint Vincent
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Louis Bonnal
First Name & Middle Initial & Last Name & Degree
Sylvie Berger
Facility Name
Hôpital privé de la Louvière
City
Lille
ZIP/Postal Code
59800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Colin, MD
First Name & Middle Initial & Last Name & Degree
Olvier Romano, MD
Facility Name
Hôpital Saint Philibert
City
Lomme
ZIP/Postal Code
59462
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Louis Bonnal
First Name & Middle Initial & Last Name & Degree
Sylvie Berger
Facility Name
Insitut Paoli Calmette
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Géraldine Pignot, MD
First Name & Middle Initial & Last Name & Degree
Gwenaelle Gravis, MD
Facility Name
Centre Hospitalier Universitaire Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric LECHEVALLIER, MD
First Name & Middle Initial & Last Name & Degree
Jean-Laurent DEVILLE, MD
Facility Name
Centre Hospitalier Universitaire Nîmes
City
Nîmes
ZIP/Postal Code
30900
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane Droupy, MD
First Name & Middle Initial & Last Name & Degree
Nadine Houédé, MD
Facility Name
Hôpital européen Georges Pompidou
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc-Olivier Timsit, MD
First Name & Middle Initial & Last Name & Degree
Constance Thibault, MD
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Masson-Lecomte, MD
First Name & Middle Initial & Last Name & Degree
Hélène Gautier, MD
Facility Name
Groupe Hospitalier Paris Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Durand
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Barry Delongchamps, MD
First Name & Middle Initial & Last Name & Degree
Olivier Huillard
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Sanchez-Salas, MD
First Name & Middle Initial & Last Name & Degree
Mostefa Bennamoun, MD
Facility Name
Centre Hospitalier Universitaire Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Traxer, MD
First Name & Middle Initial & Last Name & Degree
Ahmed Khalil, MD
Facility Name
Hôpital Diaconesses- Croix Saint Simon
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Sebe, MD
First Name & Middle Initial & Last Name & Degree
Camille Serrate, MD
Facility Name
Hôpital La Pitié Salpétrière
City
Paris
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morgan Roupret, MD-PHD
First Name & Middle Initial & Last Name & Degree
Baptiste Abbar, MD
Facility Name
Centre Hospitalier Universitaire Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69130
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain Ruffion, MD
First Name & Middle Initial & Last Name & Degree
Denis Maillet, MD
Facility Name
Centre CARIO-HPCA
City
Plérin
ZIP/Postal Code
22198
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc Corbel
First Name & Middle Initial & Last Name & Degree
Dominique Besson
Facility Name
Centre Hospitalier Universitaire Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain Mathieu, MD
Facility Name
Hôpitaux d'instruction des armées Begin
City
Saint-Mandé
ZIP/Postal Code
94160
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo Picchi, MD
First Name & Middle Initial & Last Name & Degree
Marie Dusaud, MD-PHD
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yann Neuzillet, MD-PHD
Facility Name
Hôpitaux Leman
City
Thonon-les-Bains
ZIP/Postal Code
74200
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien Pouessel, MD
Facility Name
Centre Hospitalier Universitaire Tours
City
Tours
ZIP/Postal Code
3700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck Bruyère, MD
First Name & Middle Initial & Last Name & Degree
Claude Linassier, MD
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yohann Loriot, MD
Facility Name
Hospital Universitario A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Martinez Breijo, MD
Facility Name
Hospital Universitario de Jerez de la Frontera
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Álvaro Juárez Soto, MD
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Álvaro Sánchez González, MD
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Álvarez Maestro, MD
Facility Name
Hospital General Universitario Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomás Fernández Aparicio, MD
First Name & Middle Initial & Last Name & Degree
Marta Zafra Poves, MD
Facility Name
Hospital Universitario de Canarias
City
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Cristina Plata Bello, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients

Learn more about this trial

Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients

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