A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)
- Conditions
- Renal Cell Carcinoma
- Interventions
- Registration Number
- NCT02420821
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic RCC who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 915
- Definitive diagnosis of unresectable locally advanced or metastatic RCC with clear-cell histology and/or a component of sarcomatoid carcinoma, with no prior treatment in the metastatic setting
- Evaluable Memorial Sloan Kettering Cancer Center risk score
- Measurable disease, as defined by RECIST v1.1
- Karnofsky performance status greater than or equal to 70%
- Adequate hematologic and end-organ function prior to randomization
Disease-Specific Exclusions:
- Radiotherapy for RCC within 14 days prior to treatment
- Active central nervous system disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites
- Uncontrolled hypercalcemia
- Any other malignancies within 5 years except for low-risk prostate cancer or those with negligible risk of metastasis or death
General Medical Exclusions:
- Life expectancy less than 12 weeks
- Participation in another experimental drug study within 4 weeks prior to treatment
- Pregnant or lactating women
- Known hypersensitivity to any component of atezolizumab or other study medication
- History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes mellitus
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis
- Positive human immunodeficiency virus test
- Active or chronic hepatitis B or C
- Severe infections within 4 weeks prior to treatment
- Exposure to oral or IV antibiotics within 2 weeks prior to treatment
- Live attenuated vaccines within 4 weeks prior to treatment (for influenza vaccination participants must agree not to receive live, attenuated influenza vaccine within 4 weeks prior to treatment, during treatment or within 5 months following the last dose)
- Significant cardiovascular disease
- Prior allogeneic stem cell or solid organ transplantation
Exclusion Criteria Related to Medications:
- Prior treatment with cluster of differentiation 137 agonists, anti-cytotoxic T-lymphocyte associated protein-4, anti-programmed death (PD)-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
- Treatment with immunostimulatory agents for non-malignant conditions within 6 weeks or immunosuppressive agents within 2 weeks prior to treatment
Bevacizumab- and Sunitinib-Specific Exclusions:
- History of hypertensive crisis or hypertensive encephalopathy
- Baseline electrocardiogram showing corrected QT interval greater than 460 milliseconds
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atezolizumab + Bevacizumab Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Participants will receive both atezolizumab and bevacizumab until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression, withdrawal of consent, or death, whichever occurs first. Sunitinib Sunitinib Participants will receive sunitinib until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression, withdrawal of consent, or death, whichever occurs first. Atezolizumab + Bevacizumab Bevacizumab Participants will receive both atezolizumab and bevacizumab until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression, withdrawal of consent, or death, whichever occurs first.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) Tumor response was assessed by the investigator according to RECIST v1.1. Disease Progression (PD) was defined as greater than or equal to (\>/=) 20 percent (%) relative increase in the sum of diameters (SoD) of all target lesions (TLs), taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 millimeters (mm); \>/=1 new lesion(s); and/or unequivocal progression of existing non-TLs.
Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. PD: \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Participants with a PFS event who missed \>/=2 scheduled assessments immediately prior to the PFS event were censored at the last tumor assessment prior to the missed visits. Median PFS was estimated by Kaplan-Meier method and 95% confidence interval (CI) was assessed using the method of Brookmeyer and Crowley.
Percentage of Participants Who Died of Any Cause in ITT Population Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) Percentage of participants who died of any cause was reported.
Overall Survival (OS) in ITT Population Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Died of Any Cause in PD-L1-Selected Population Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) Percentage of participants who died of any cause was reported.
OS in PD-L1-Selected Population Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Percentage of Participants With PD as Determined by an Independent Review Committee (IRC) According to RECIST v1.1 or Death From Any Cause in ITT Population Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) Tumor response was assessed by an IRC according to RECIST v1.1. PD was defined as \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs.
PFS as Determined by an IRC According to RECIST v1.1 in ITT Population Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) PFS was defined as the time from randomization to PD, as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. PD: \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Percentage of Participants With PD as Determined by an IRC According to RECIST v1.1 or Death From Any Cause in PD-L1-Selected Population Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) Tumor response was assessed by an IRC according to RECIST v1.1. PD was defined as \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs.
PFS as Determined by an IRC According to RECIST v1.1 in PD-L1-Selected Population Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) PFS was defined as the time from randomization to PD, as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. PD: \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator According to RECIST v1.1 in Objective Response Rate (ORR)-Evaluable Population Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) Tumor response was assessed by the investigator according to RECIST v1.1. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs and (if applicable) normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to less than (\<) 10 mm. PR was defined as \>/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of \>/=1 non-TL(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders.
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 in DOR-Evaluable Population Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) DOR was defined as the time from the first occurrence of CR/PR to PD as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs and normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to \<10 mm. PR: \>/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of \>/=1 non-TL(s) and/or maintenance of tumor marker level above the normal limits. PD: \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley.
Percentage of Participants With an Objective Response of CR or PR as Determined by an IRC According to RECIST v1.1 in ORR-Evaluable Population Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) Tumor response was assessed by an IRC according to RECIST v1.1. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs and (if applicable) normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to \<10 mm. PR was defined as \>/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of \>/=1 non-TL(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders.
DOR as Determined by an IRC According to RECIST v1.1 in DOR-Evaluable Population Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) DOR was defined as the time from the first occurrence of CR/PR to PD as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs and normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to \<10 mm. PR: \>/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of \>/=1 non-TL(s) and/or maintenance of tumor marker level above the normal limits. PD: \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley.
Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item Baseline (Day 1 Cycle 1); every week for first 12 weeks, Days 1 and 22 of each cycle (Cycle 3 up to 19), within 30 days of PD (up to 27 months), at EoT (up to 27 months) and at 6, 12, 24, and 36 weeks after EoT (overall up to 27 months); 1 cycle=42 days The BFI is a valid and reliable self-report questionnaire used to assess the severity and impact of cancer-related fatigue. BFI worst fatigue item assessed the severity of fatigue at its worst in the last 24 hours. The item was rated on a scale of 0 (not present) to 10 (as bad as you can imagine). Change from baseline in the score at each time point is reported, where a negative value indicates improvement.
Percentage of Participants With PD as Determined by the Investigator According to Immune-Modified RECIST or Death From Any Cause in ITT Population Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) Tumor response was assessed by the investigator according to immune-modified RECIST. PD was defined as \>/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm.
PFS as Determined by the Investigator According to Immune-Modified RECIST in ITT Population Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) PFS was defined as the time from randomization to PD, as determined by the investigator per immune-modified RECIST or death from any cause, whichever occurred first. PD: \>/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Percentage of Participants With an Objective Response of CR or PR as Determined by the Investigator According to Immune-Modified RECIST in ORR-Evaluable Population Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) Tumor response was assessed by the investigator according to immune-modified RECIST. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs or reduction in short axis of any pathological lymph nodes to \<10 mm. PR was defined as \>/=30% decrease in the SoD of TLs and all new measurable lesions (taking as reference the baseline SoD), in the absence of CR. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders.
DOR as Determined by the Investigator According to Immune-Modified RECIST in DOR-Evaluable Population Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) DOR was defined as the time from the first occurrence of CR/PR to PD as determined by the investigator per immune-modified RECIST or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs or reduction in short axis of any pathological lymph nodes to \<10 mm. PR: \>/=30% decrease in the SoD of TLs and all new measurable lesions (taking as reference the baseline SoD), in the absence of CR. PD: \>/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley.
Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in ITT Population Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs.
PFS as Determined by the Investigator According to RECIST v1.1 in ITT Population Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. PD: \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Participants with a PFS event who missed \>/=2 scheduled assessments immediately prior to the PFS event were censored at the last tumor assessment prior to the missed visits. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in Participants With Sarcomatoid Histology Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs.
PFS as Determined by the Investigator According to RECIST v1.1 in Participants With Sarcomatoid Histology Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. PD: \>/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of \>/=5 mm; \>/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Percentage of Participants Who Died of Any Cause in Participants With Sarcomatoid Histology Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) Percentage of participants with sarcomatoid histology who died of any cause was reported.
OS in Participants With Sarcomatoid Histology Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score Baseline (Day 1 Cycle 1); Day 22 Cycle 1; Day 1 and 22 of every cycle from Cycle 2 up to Cycle 19; Cycle length = 42 days The MDASI is a cancer-related, multi-symptom, valid, and reliable self-report questionnaire that comprises of 23 items and two subscales: symptom severity (17 items) and symptom interference (6 items). In Part II, participants were asked to rate how much the symptoms have interfered with 6 areas of function (general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours. Each item was rated on a scale of 0 (does not interfere) to 10 (interfered completely) and total Part II score was calculated as an average of 6-item scores. Repeated measures model-estimated least-squares (LS) mean score for changes from baseline is reported at each timepoint, where a negative value indicates improvement. Here, 'Number Analyzed' = number of participants evaluable at specified time point.
Change From Baseline in Symptom Severity as Determined by MDASI Part I Score Baseline; End of Treatment (EoT) visit (up to approximately 27 months) The MDASI is a cancer-related, multi-symptom, valid, and reliable self-report questionnaire that comprises of 23 items and two subscales: symptom severity (17 items) and symptom interference (6 items). In Part I, participants were asked to rate how severe the symptoms (pain, fatigue, nausea, disturbed sleep, feeling of being distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, feeling sad, vomiting, numbness or tingling, rash/skin changes, headache, mouth/throat sores, and diarrhea) were when "at their worst" in the last 24 hours. Each item was rated on a scale of 0 (not present) to 10 (as bad as you can imagine). Mixed-effects model-estimated LS mean score for change from baseline at the end-of treatment is reported for each item, where a negative value indicates improvement.
Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score Baseline (Day 1 Cycle 1); every week for first 12 weeks, Days 1 and 22 of each cycle (Cycle 3 up to 19), within 30 days of PD (up to 27 months), at EoT (up to 27 months) and at 6, 12, 24, and 36 weeks after EoT (overall up to 27 months); 1 cycle=42 days The BFI is a valid and reliable self-report questionnaire used to assess the severity and impact of cancer-related fatigue. BFI interference subscale (6 items) assessed the impact of fatigue on global domains (general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life) in the last 24 hours. Each item was rated on a scale of 0 (does not interfere) to 10 (interfered completely). Change from baseline in the mean score of all 6 items at each timepoint is reported, where a negative value indicates improvement.
Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score Day 1 and 22 of every cycle (Baseline = Day 1 Cycle 1) up to Cycle 19; Cycle length = 42 days The FKSI-19 is a 19-item tool designed to assess the most important symptoms and concerns related to treatment effectiveness in advanced kidney cancer. The FKSI-19 GP5 item (bothered by the side effect of treatment) assessed side effects burden in the past 7 days on a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Repeated measures model-estimated LS mean score for changes from baseline is reported at each timepoint, where a negative value indicates improvement.
Number of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycles 2, 4, and 8, and every eight cycles thereafter up to EoT [up to approximately 27 months] and 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days) The number of participants with "Treatment-induced ATAs" and "Treatment-enhanced ATA" against atezolizumab at any time during or after treatment was reported. Treatment-induced ATA = a participant with negative or missing Baseline ATA result(s) and at least one positive post-Baseline ATA result. Treatment-enhanced ATA = a participant with positive ATA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result. Here, 'Overall Number of Participants Analyzed' = number of participants with a non-missing baseline ATA sample; 'Number Analyzed' = number of participants with a non-missing ATA sample at indicated timepoint.
Number of Participants With ATAs Against Bevacizumab Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycle 3, at EoT [up to approximately 27 months] and at 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days) The number of participants with "Treatment-induced ATAs" and "Treatment-enhanced ATA" against bevacizumab at any time during or after treatment was reported. Treatment-induced ATA = a participant with negative or missing Baseline ATA result(s) and at least one positive post-Baseline ATA result. Treatment-enhanced ATA = a participant with positive ATA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.
Maximum Observed Serum Concentration (Cmax) for Atezolizumab 30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days) Cmax for atezolizumab was estimated from plasma concentration versus time data.
Minimum Observed Serum Concentration (Cmin) for Atezolizumab Predose (Hour 0) on Day 22 of Cycle 1; predose (Hour 0) on Day 1 of Cycles 2; Cycle length = 42 days Cmin for atezolizumab was estimated from plasma concentration versus time data.
Cmax for Bevacizumab 30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days) Cmax for bevacizumab was estimated from plasma concentration versus time data.
Cmin for Bevacizumab Pre-dose (Hour 0) on Day 1 of Cycle 3 (Cycle length = 42 days) Cmin for bevacizumab was estimated from plasma concentration versus time data.
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Trial Locations
- Locations (154)
Lynn Cancer Institute/Boca Raton Regional Hospital
🇺🇸Boca Raton, Florida, United States
Florida Cancer Specialists - Port Charlotte
🇺🇸Port Charlotte, Florida, United States
Texas Oncology-Baylor Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Piedmont Cancer Institute, PC
🇺🇸Atlanta, Georgia, United States
Lifehouse
🇦🇺Camperdown, New South Wales, Australia
St John of God Hospital
🇦🇺Murdoch, Western Australia, Australia
Sunnybrook Odette Cancer Centre
🇨🇦Toronto, Ontario, Canada
Cleveland Clinic Foundation; Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Inst.
🇺🇸Boston, Massachusetts, United States
Comprehensive Cancer Centers of Nevada - Eastern Avenue
🇺🇸Las Vegas, Nevada, United States
Oncology Hematology Care Inc
🇺🇸Cincinnati, Ohio, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Queen Elizabeth II Health Sciences Centre; Oncology
🇨🇦Halifax, Nova Scotia, Canada
Instituto do Cancer do Estado de Sao Paulo - ICESP
🇧🇷Sao Paulo, SP, Brazil
Royal Victoria Hospital
🇨🇦Barrie, Ontario, Canada
ICO - Site René Gauducheau
🇫🇷Saint Herblain, France
Institut Gustave Roussy; Departement Oncologie Medicale
🇫🇷Villejuif, France
A.O. Universitaria Policlinico Di Modena; Oncologia
🇮🇹Modena, Emilia-Romagna, Italy
Hamilton Health Sciences - Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
The Ottawa Hospital Cancer Centre; Oncology
🇨🇦Ottawa, Ontario, Canada
ICO Paul Papin; Oncologie Medicale.
🇫🇷Angers, France
Centre Francois Baclesse; Urologie Gynecologie
🇫🇷Caen, France
Osaka International Cancer Institute; Urology
🇯🇵Osaka, Japan
National Cancer Center
🇰🇷Goyang-si, Korea, Republic of
Niigata University Medical & Dental Hospital
🇯🇵Niigata, Japan
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
🇪🇸Sevilla, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
🇪🇸Madrid, Spain
Taichung Veterans General Hospital; Division of Urology
🇨🇳Taichung, Taiwan
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
🇪🇸Sabadell, Barcelona, Spain
Royal Marsden Hospital; Dept of Medical Oncology
🇬🇧Sutton, United Kingdom
ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic
🇷🇺Barnaul, Altaj, Russian Federation
Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit
🇹🇭Chiangmai, Thailand
P.A. Herzen Oncological Inst. ; Oncology
🇷🇺Moscow, Russian Federation
Centro Oncologico Estatal ISSEMYM
🇲🇽Toluca, Mexico
Hospital Universitario Reina Sofia; Servicio de Oncologia
🇪🇸Córdoba, Cordoba, Spain
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna
🇵🇱Poznan, Poland
Royal Free Hospital; Dept of Oncology
🇬🇧London, United Kingdom
University of California
🇺🇸San Francisco, California, United States
Sarah Cannon Cancer Center and Research Institute
🇺🇸Nashville, Tennessee, United States
London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Princess Margaret Cancer Center
🇨🇦Toronto, Ontario, Canada
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
🇩🇪Dresden, Germany
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
🇩🇪Essen, Germany
Lakeridge Health Oshawa; Oncology
🇨🇦Oshawa, Ontario, Canada
University of California at Irvine Medical Center; Department of Oncology
🇺🇸Orange, California, United States
Georgetown U; Lombardi Comp Can
🇺🇸Washington, District of Columbia, United States
Rocky Mountain Cancer Center; Medical Oncology
🇺🇸Boulder, Colorado, United States
Florida Cancer Specialist, North Region
🇺🇸Saint Petersburg, Florida, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
New York Oncology Hematology,P.C.-Albany
🇺🇸Albany, New York, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Northwest Cancer Specialists, P.C.
🇺🇸Tigard, Oregon, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
SCRI Tennessee Oncology Chattanooga
🇺🇸Chattanooga, Tennessee, United States
Oncology and Hematology Associates of SW Virginia-Raonoke
🇺🇸Roanoke, Virginia, United States
Vanderbilt Univ Medical Ctr
🇺🇸Nashville, Tennessee, United States
Calvary Mater Newcastle; Medical Oncology
🇦🇺Waratah, New South Wales, Australia
Macquarie University Hospital
🇦🇺Macquarie Park, New South Wales, Australia
Ashford Cancer Center Research
🇦🇺Kurralta Park, South Australia, Australia
Icon Cancer Foundation
🇦🇺South Brisbane, Queensland, Australia
Austin Hospital; Medical Oncology
🇦🇺Heidelberg, Victoria, Australia
University Clinical Centre of the Republic of Srpska
🇧🇦Banja Luka, Bosnia and Herzegovina
Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
Hospital de Caridade de Ijui; Oncologia
🇧🇷Ijui, RS, Brazil
Hospital Sao Lucas - PUCRS
🇧🇷Porto Alegre, RS, Brazil
CHU de Quebec Hotel-Dieu de Quebec
🇨🇦Quebec City, Quebec, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Thomayerova nemocnice
🇨🇿Praha 4 - Krc, Czechia
Masarykuv onkologicky ustav
🇨🇿Brno, Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika
🇨🇿Olomouc, Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
🇨🇿Praha 2, Czechia
Aarhus Universitetshospital; Kræftafdelingen
🇩🇰Aarhus N, Denmark
Herlev Hospital; Afdeling for Kræftbehandling
🇩🇰Herlev, Denmark
Hopital Saint Andre; Oncologie 2
🇫🇷Bordeaux, France
Centre Oscar Lambret
🇫🇷Lille, France
Odense Universitetshospital, Onkologisk Afdeling R
🇩🇰Odense C, Denmark
Centre D'Oncologie de Gentilly; Oncology
🇫🇷Nancy, France
APHP - Hospital Saint Louis
🇫🇷Paris, France
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
🇫🇷Paris, France
Centre Léon Bérard
🇫🇷Lyon, France
Institut Paoli Calmettes; Oncologie Medicale
🇫🇷Marseille, France
Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg
🇩🇪Heidelberg, Germany
Klinikum d.Universität München Campus Großhadern
🇩🇪München, Germany
Universitätsklinikum Tübingen; Klinik für Urologie
🇩🇪Tübingen, Germany
Irccs Ospedale San Raffaele;Oncologia Medica
🇮🇹Milano, Lombardia, Italy
Az. Osp. Cardarelli; Divisione Di Oncologia
🇮🇹Napoli, Campania, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
🇮🇹Milano, Lombardia, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
🇮🇹Meldola, Emilia-Romagna, Italy
Fondazione IRCCS Policlinico San Matteo, Oncologia
🇮🇹Pavia, Lombardia, Italy
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
🇮🇹Arezzo, Toscana, Italy
Nagoya University Hospital; Urology
🇯🇵Aichi, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Chiba Cancer Center
🇯🇵Chiba, Japan
Gunma University Hospital
🇯🇵Gunma, Japan
Hokkaido University Hospital
🇯🇵Hokkaido, Japan
University of Tsukuba Hospital; Urology
🇯🇵Ibaraki, Japan
Iwate Medical University Hospital
🇯🇵Iwate, Japan
Yokohama City University Hospital
🇯🇵Kanagawa, Japan
Kitasato University Hospital
🇯🇵Kanagawa, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Osaka Metropolitan University Hospital
🇯🇵Osaka, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Kindai University Hospital
🇯🇵Osaka, Japan
Osaka University Hospital
🇯🇵Osaka, Japan
Keio University Hospital
🇯🇵Tokyo, Japan
Tokyo Medical and Dental University Hospital
🇯🇵Tokyo, Japan
Tokushima University Hospital
🇯🇵Tokushima, Japan
The Cancer Institute Hospital, JFCR; Urology
🇯🇵Tokyo, Japan
Nippon Medical School Hospital
🇯🇵Tokyo, Japan
Toranomon Hospital
🇯🇵Tokyo, Japan
Tokyo Women's Medical University
🇯🇵Tokyo, Japan
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
GBUZ Nizhegorodskay Region: Clinical Diagnostic Center
🇷🇺Nizhni Novgorod, Niznij Novgorod, Russian Federation
MAGODENT Sp. z o.o.
🇵🇱Warsaw, Poland
City Clinical Oncology Hospital
🇷🇺Moscow, Russian Federation
Hospital Clínic i Provincial; Servicio de Oncología
🇪🇸Barcelona, Spain
National Cancer Centre; Medical Oncology
🇸🇬Singapore, Singapore
Hospital Univ Vall d'Hebron; Servicio de Oncologia
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
🇪🇸Madrid, Spain
Hospital Duran i Reynals; Oncologia
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
🇪🇸Madrid, Spain
National Taiwan Uni Hospital; Dept of Oncology
🇨🇳Taipei, Taiwan
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
🇹🇭Bangkok, Thailand
Songklanagarind Hospital; Department of Oncology
🇹🇭Songkhla, Thailand
Hacettepe University Medical Faculty
🇹🇷Ankara, Turkey
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
🇹🇷Edirne, Turkey
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
🇹🇷Istanbul, Turkey
Addenbrookes Nhs Trust; Oncology Clinical Trials Unit
🇬🇧Cambridge, United Kingdom
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Clatterbridge Cancer Centre
🇬🇧Bebington, United Kingdom
Royal Blackburn Hospital
🇬🇧Blackburn, United Kingdom
Barts Health NHS Trust - St Bartholomew's Hospital
🇬🇧London, United Kingdom
Churchill Hospital; Oxford Cancer and Haematology Centre
🇬🇧Oxford, United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
🇬🇧Manchester, United Kingdom
Singleton Hospital; Pharmacy Department
🇬🇧Swansea, United Kingdom
Southampton General Hospital; Medical Oncology
🇬🇧Southampton, United Kingdom
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
University of Colorado; Anschutz Cancer Pavilion
🇺🇸Aurora, Colorado, United States
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
🇹🇭Bangkok, Thailand
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
🇵🇱Lublin, Poland
National University Hospital
🇸🇬Singapore, Singapore
Chulalongkorn Hospital; Medical Oncology
🇹🇭Bangkok, Thailand
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
🇮🇹Roma, Lazio, Italy
Chang Gung Medical Foundation-Linkou, Urinary Oncology
🇨🇳Taoyuan, Taiwan
Cancerología
🇲🇽Queretaro, Mexico
Saint Elizabeth's Hospital
🇵🇱Warsaw, Poland
The University of Chicago
🇺🇸Chicago, Illinois, United States