Bladder Cancer Clinical Trial
Official title:
A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Verified date | March 2024 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. The results of Cohort 1 are reported separately (NCT02951767). Cohort 2 (reported here) will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity.
Status | Completed |
Enrollment | 310 |
Est. completion date | February 28, 2023 |
Est. primary completion date | July 4, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, urethra) - Representative tumor specimens as specified by the protocol - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Life expectancy greater than or equal to (>=) 12 weeks - Measurable disease, as defined by RECIST v1.1 - Adequate hematologic and end organ function Cohort 2-Specific Inclusion Criteria - Disease progression during or following treatment with at least one platinum-containing regimen (e.g., gemcitabine and cisplatin [GC], methotrexate, vinblastine, doxorubicin, and cisplatin [MVAC], CarboGem, etc.) for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence. - A regimen was defined as participants receiving at least two cycles of a platinum-containing regimen. Participants who had received one cycle of a platinum-containing regimen but discontinued due to Grade 4 hematologic toxicity or Grade 3 or 4 non-hematologic toxicity could also be eligible. - Participants who received prior adjuvant/neoadjuvant chemotherapy and progressed within 12 months of treatment with a platinum-containing adjuvant/neoadjuvant regimen were considered as second-line participants. Exclusion Criteria: - Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment - Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment - Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments - Leptomeningeal disease - Uncontrolled tumor-related pain - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) - Uncontrolled hypercalcemia (greater than [>] 1.5 millimoles per liter [mmol/L] ionized calcium or Ca > 12 milligrams per deciliter [mg/dL] or corrected serum calcium > upper limits of normal [ULN]) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab - Malignancies other than urothelial bladder cancer within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome or incidental prostate cancer - Pregnant and lactating women - History of autoimmune disease - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan - Serum albumin less than (<) 2.5 grams per deciliter (g/dL) - Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis - Severe infections within 4 weeks prior to Cycle 1, Day 1 - Significant cardiovascular disease - Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1 - Prior allogeneic stem cell or solid organ transplant - Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 - 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 - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4), anti-programmed death-1 receptor (anti-PD-1), and anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies |
Country | Name | City | State |
---|---|---|---|
Canada | Bcca - Cancer Center Southern Interior | Kelowna | British Columbia |
Canada | McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology | Montreal | Quebec |
Canada | Lakeridge Health Oshawa; Oncology | Oshawa | Ontario |
Canada | The Ottawa Hospital Cancer Centre; Oncology | Ottawa | Ontario |
Canada | Sunnybrook Odette Cancer Centre | Toronto | Ontario |
Canada | University Health Network; Princess Margaret Hospital; Medical Oncology Dept | Toronto | Ontario |
Canada | BCCA-Vancouver Cancer Centre | Vancouver | British Columbia |
France | APHP - Hospital Saint Louis | Paris | |
France | Hopital Foch; Oncologie | Suresnes | |
France | Institut Gustave Roussy; Oncologie Medicale | Villejuif | |
Germany | Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie | Berlin | |
Germany | Universitätsklinikum Düsseldorf; Urologische Klinik | Düsseldorf | |
Germany | Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie | Freiburg | |
Germany | Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II | Hamburg | |
Germany | Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik | München | |
Italy | Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia | Arezzo | Toscana |
Italy | Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2 | Milano | Lombardia |
Netherlands | The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis | Amsterdam | |
Spain | Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | |
Spain | Institut Catala d Oncologia Hospital Duran i Reynals | Barcelona | |
Spain | Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | |
Spain | Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | |
Spain | Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | |
Spain | Clinica Universitaria de Navarra; Servicio de Oncologia | Pamplona | Navarra |
Spain | Hospital Universitario Virgen del Rocio; Servicio de Oncologia | Sevilla | |
United Kingdom | University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital | Birmingham | |
United Kingdom | Barts and The London | London | |
United Kingdom | Sarah Cannon Research Institute | London | |
United Kingdom | Royal Marsden Hospital; Dept of Medical Oncology | Sutton | |
United Kingdom | The Clatterbridge Cancer Centre NHS Foundation Trust | Wirral | |
United States | New York Oncology Hematology, P.C. | Albany | New York |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Piedmont Cancer Institute, PC | Atlanta | Georgia |
United States | Rocky Mountain Cancer Center - Aurora | Aurora | Colorado |
United States | University Of Colorado | Aurora | Colorado |
United States | University of Alabama At Birmingham | Birmingham | Alabama |
United States | Beth Israel Deaconess Medical Center, Harvard Medical School; Department of Medicine | Boston | Massachusetts |
United States | Dana Farber Cancer Inst. ; Dept. of Medical Oncology | Boston | Massachusetts |
United States | Massachusetts General Hospital;Oncology | Boston | Massachusetts |
United States | University of Chicago; Hematology/Oncology | Chicago | Illinois |
United States | Oncology Hematology Care Inc | Cincinnati | Ohio |
United States | Case Western Reserve Univ; Hem/Onc | Cleveland | Ohio |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Karmanos Cancer Institute | Detroit | Michigan |
United States | Willamette Valley Cancer Ctr - 520 Country Club | Eugene | Oregon |
United States | Virginia Cancer Specialists, PC | Fairfax | Virginia |
United States | University of Connecticut Health Center | Farmington | Connecticut |
United States | Ctr for Cancer and Blood Disorders | Fort Worth | Texas |
United States | Indiana University Health; Goshen Center for Cancer Care | Goshen | Indiana |
United States | Ingalls Memorial Hospital | Harvey | Illinois |
United States | Houston Methodist Hospital | Houston | Texas |
United States | Texas Oncology - Houston (Gessner) | Houston | Texas |
United States | Mayo Clinic Cancer Center | Jacksonville | Florida |
United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
United States | The Angeles Clinic and Research Institute - W LA Office | Los Angeles | California |
United States | UCLA | Los Angeles | California |
United States | USC Norris Cancer Center | Los Angeles | California |
United States | Norton Cancer Institute | Louisville | Kentucky |
United States | Minnesota Oncology Minneapolis | Minneapolis | Minnesota |
United States | Sarah Cannon Cancer Center - Tennessee Oncology, Pllc | Nashville | Tennessee |
United States | Yale Cancer Center ; Medical Oncology | New Haven | Connecticut |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Mount Sinai School of Medicine - Tisch Cancer Institute | New York | New York |
United States | NYU Langone Medical Center | New York | New York |
United States | Virginia Oncology Associates - Lake Wright Cancer Center | Norfolk | Virginia |
United States | Urology Cancer Center & GU Research Network | Omaha | Nebraska |
United States | Kimmel Cancer Center Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Mayo Clinic - Rochester | Rochester | Minnesota |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | UCSF | San Francisco | California |
United States | Kaiser Permanente - San Marcos | San Marcos | California |
United States | Pinnacle Oncology Hematology | Scottsdale | Arizona |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
United States | Stanford Cancer Center | Stanford | California |
United States | Arizona Oncology - HOPE Wilmot | Tucson | Arizona |
United States | Kaiser Permanente; Oncology Clinical Trials | Vallejo | California |
United States | Georgetown University Medical Center Lombardi Cancer Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (=) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed =4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | |
Primary | Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According Modified RECIST | Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as =30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed =4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | |
Secondary | Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1 | DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as =30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or progressive disease (PD) was defined as =20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed =4 weeks after the initial assessment of CR or PR. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | |
Secondary | DOR as Assessed by the Investigator According to RECIST v1.1 | DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as =30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as =20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed =4 weeks after the initial assessment of CR or PR. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | |
Secondary | DOR as Assessed by the Investigator According to Modified RECIST | DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as =30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as =20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed =4 weeks after the initial assessment of CR or PR. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | |
Secondary | Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1 | Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as =20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | |
Secondary | Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1 | PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as =20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | |
Secondary | Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1 | Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as =20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | |
Secondary | PFS as Assessed by the Investigator According to RECIST v1.1 | PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as =20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | |
Secondary | Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to Modified RECIST | Tumor response was assessed by the investigator according to modified RECIST. Disease progression or PD was defined as =20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | |
Secondary | PFS as Assessed by the Investigator According to Modified RECIST | PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to modified RECIST. Disease progression or PD was defined as =20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | |
Secondary | Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According RECIST v1.1 | Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as =30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed =4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | |
Secondary | Percentage of Participants Who Died | The percentage of participants who died from any cause was reported. | Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | |
Secondary | Overall Survival (OS) | OS was defined as the time from start of treatment to the time of death from any cause on study. | Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) | |
Secondary | Percentage of Participants Alive at 1-year | 1-year | ||
Secondary | Maximum Serum Concentration (Cmax) of Atezolizumab | Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days) | ||
Secondary | Minimum Serum Concentration (Cmin) of Atezolizumab | Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days) | ||
Secondary | Percentage of Participants Positive for Anti-therapeutic Antibodies (ATA) to Atezolizumab | Day 1 of all cycles (Cycle length = 21 days) and at treatment discontinuation (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
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