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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001364-19 | EudraCT Number |
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This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment consisting of atezolizumab in combination with either obinutuzumab + bendamustine (Atezo-G-benda) or obinutuzumab + CHOP (Atezo-G-CHOP) in participants with FL and atezolizumab + rituximab + chemotherapy (Atezo-R-CHOP) in participants with DLBCL, followed by post-induction treatment consisting of either atezolizumab plus obinutuzumab (Atezo-G) in participants with FL who achieve a complete response (CR) or partial response (PR) at end of induction (EOI) or atezolizumab alone in participants with DLBCL who achieve a CR at EOI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezo-G-Benda (Safety Run-In and Expansion Phases) | Experimental | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL will receive obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL will receive same treatment regimen as described for safety run-in phase. |
|
| Atezo-G-CHOP (Safety Run-In Phase) | Experimental | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL will receive obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment. |
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| Atezo-R-CHOP (Expansion Phase) | Experimental | Participants with previously untreated DLBCL will receive rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezo-G-Benda: Atezolizumab 840 milligrams (mg) intravenously (IV) on Days 1 and 15 of Cycles 2-6, during induction treatment, followed by 840 mg IV on Days 1 and 2 of each month, starting with Month 1, during maintenance treatment. Atezo-G-CHOP: Atezolizumab 1200 mg IV on Day 1 Cycles 2-6, during induction treatment, followed by 840 mg IV on Days 1 and 2 of each month, starting with Month 1. Atezo-R-CHOP: Atezolizumab 1200 mg IV on Day 1 Cycles 2-8, during induction treatment, followed by 1200 mg IV on Day 1 of Cycles 9-25. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria | Primary end point was positron emission tomography (PET) CR at EOI by IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [](streamdown:incomplete-link) | Up to approximately 6 months |
| Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Baseline up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With CR at EOI, as Determined by the Investigator Using Lugano 2014 Criteria | Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake \ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Cancer Center - Aurora | Aurora | Colorado | 80012 | United States | ||
| Georgetown University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36287231 | Derived | Younes A, Burke JM, Cheson BD, Diefenbach CS, Ferrari S, Hahn UH, Hawkes EA, Khan C, Lossos IS, Musuraca G, Tani M, Vitolo U, Yuen S, Raval A, Shivhare M, Nielsen TG, Sellam G, Sharman JP. Safety and efficacy of atezolizumab with rituximab and CHOP in previously untreated diffuse large B-cell lymphoma. Blood Adv. 2023 Apr 25;7(8):1488-1495. doi: 10.1182/bloodadvances.2022008344. | |
| 35359000 |
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Out of the 117 subjects who were screened for this study, 91 subjects were enrolled to either FL treatment cohort (Atezo-G-Benda, Atezo-G-CHOP) or DLBCL cohort (Atezo-R-CHOP) and 26 subjects failed screening.
The study was conducted at 15 sites in 3 countries (Italy, Australia, and USA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2018 |
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| Bendamustine | Drug | Bendamustine will be administered at a dose of 90 milligrams per square meter (mg/m^2) IV on Days 1 and 2 of Cycles 1-6, during induction treatment. |
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| Cyclophosphamide | Drug | Cyclophosphamide will be administered at a dose of 750 mg/m^2 IV on Day 1 of Cycle 1-6/8, during induction treatment. |
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| Doxorubicin | Drug | Doxorubicin will be administered at a dose of 50 mg/m^2 IV on Day 1 of Cycle 1-6/8, during induction treatment. |
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| Obinutuzumab | Drug | Atezo-G-Benda: Obinutuzumab will be administered at a dose of 1000 mg IV on Days 1, 8, and 15 of Cycle 1 and 1000 mg IV on Day 1 of Cycles 2-6, during induction treatment, followed by 1000 mg IV on Day 1 of every other month, starting with Month 1, during maintenance treatment. Atezo-G-CHOP: Obinutuzumab will be administered at a dose of 1000 mg IV on Days 1, 8, and 15 of Cycle 1 and 1000 mg IV on Day 1 of Cycles 2-6 during induction treatment, followed by 1000 mg IV on Day 1 of every other month, starting with Month 1 during maintenance treatment. |
|
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| Prednisone | Drug | Prednisone will be administered at a dose of 40 mg/m^2 orally on Days 1-5 of Cycle 1-6/8, during induction treatment. Prednisolone may be given if prednisone is unavailable. The 40 mg/m^2 dose of prednisone on Day 1 will be replaced by oral corticosteroids given as premedication on Day 1 of Cycle 1 (and subsequent cycles). |
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| Vincristine | Drug | Vincristine will be administered at a dose of 1.4 mg/m^2 (maximum 2 mg) IV on Day 1 of Cycle 1-6/8, during induction treatment. |
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| Rituximab | Drug | Atezo-R-CHOP: Participants with previously untreated DLBCL will receive rituximab at a dose of 375 mg/m^2 IV on Day 1 of Cycle 1-8, during induction treatment. |
|
| Up to approximately 6 months |
| Percentage of Participants With CR at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria | Complete response according to the modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. Partial Response (PR): at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. | Up to approximately 6 months |
| Percentage of Participants With CR at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria | Complete response according to modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. | Up to approximately 6 months |
| Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria | Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. | Up to approximately 6 months |
| Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria | Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. | Up to approximately 6 months |
| Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Lugano 2014 Criteria | Tumor response assessment was performed by IRC according to modified Lugano classification using PET/CT scan. OR defined as a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with/without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR: a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. | Up to approximately 6 months |
| Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Lugano 2014 Criteria | Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR: a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes & extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR with a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. | Up to approximately 6 months |
| Percentage of Participants With Best Response of CR or PR During Study, as Determined by Investigator Using Modified Cheson 2007 Criteria | CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. | Baseline up to approximately 4 years (assessed at Baseline, 6 to 8 weeks after Day [D] 1 of Cycle [Cy] 6 or 8 (1Cy: 21 or 28 days), then every 2 months up to 24 months, at 35 days of last dose, and at every 3 months post-treatment follow-up [up 4 years]) |
| Observed Serum Obinutuzumab Concentration | Predose time point was "any time prior to dose" for Cycle (Cy) 1 and "within 5 hour prior to dose" for other cycles (Cy 2,5,6) and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 milligrams per hour (mg/hour). If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. | Induction: Predose, 0.5 hour (h) postinfusion on Day (D) 1 of Cy1,2,5,6 (1Cy: 21/28 days); Maintenance: Predose, 0.5h postinfusion on Day 1 of Month 1,3,7,15,23; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years) |
| Observed Serum Atezolizumab Concentration | Atezo-G-Benda: Induction:Predose on D1 of Cy5,6 & D1,15 of Cy2,3 (1Cy:21/28 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years); Atezo-G-CHOP: Induction:Predose on D1 of Cy2,3,5,6 (1Cy:21 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,3,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years). Predose time point was "within 5 hour prior to dose" for Cy2,3,5,6 during induction phase and for Months 1 to 24 during maintenance phase. infusion length: 30-60 minutes. | Atezo-R-CHOP: Predose on D1 of Cy2,3,5,8,9,10,11,12,16,20,25 (1Cy:21 days), 0.5h postinfusion of D1 of Cy2,9; at 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years) |
| Observed Serum Rituximab Concentration | Predose time point was "any time prior to dose" for Cycle 1 and "within 5 hour prior to dose" for other cycles (Cycles 2,5,8) during induction phase and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 mg/hour. If no infusion-related or hypersensitivity reaction occurs, increase the infusion rate in 50 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. | Predose, 0.5h postinfusion on D1 of Cy1,2,5,8 (1Cy: 21 days); at 120 days and 1 year after last rituximab dose or at treatment discontinuation (up to 4 years) |
| Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab | Induction: Predose (any time prior to dose) on D1 of Cy1,5,6 (1Cy: 21/28 days); Maintenance: Predose (any time prior to dose) on D1 of Month 1; at 120 days and 1 year of last obinutuzumab dose or at treatment discontinuation (up to 4 years) | Baseline up to approximately 4 years |
| Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab | Induction: Predose (any time prior to dose) on D1 of Cy1,5,8 (1Cy: 21 days); Maintenance: at 120 days and 1 year of last rituximab dose or at treatment discontinuation (up to 4 years) | Baseline up to approximately 4 years |
| Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab | Atezo-G-CHOP: Induction: Predose on D1 of Cy2,3,5,6 (1 Cy: 21 days); Maintenance: Predose on D1 of Month 1,2,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years); Atezo-R-CHOP: Predose on D1 of Cy 2,3,5,8,16,25 (1 Cy: 21 days); at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). Predose time point was "any time prior to dose" for Cycles 2,3,5,6,8 during induction phase, for Cycles 16,25 during consolidation treatment, and for Months 1 to 24 during maintenance phase. Atezo-G-Benda: Induction: Predose on D1 of Cy2,3,5,6 (1Cy: 28 days), Cy3D15: Predose; ; Maintenance: Predose on D1 of Month 1,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). The percentage of participants with positive results for ATAs to atezolizumab at baseline and at post-baseline time points are reported. | Baseline up to approximately 4 years |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| University Miami | Miami | Florida | 33136 | United States |
| New York Uni Medical Center | New York | New York | 10016 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute | Springfield | Oregon | 97477 | United States |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| Texas Oncology | Austin | Texas | 78705 | United States |
| Texas Oncology-Tyler | Irving | Texas | 75063 | United States |
| Concord Repatriation General Hospital; Haematology | Sydney | New South Wales | 2139 | Australia |
| Calvary Mater Newcastle | Waratah | New South Wales | 2298 | Australia |
| The Queen Elizabeth Hospital; Haematology/Oncology | Woodville South | South Australia | 5011 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Austin Hospital | Heidelberg | Victoria | 3084 | Australia |
| Azienda Ospedaliera S. Orsola-Malpighi | Bologna | Emilia-Romagna | 40138 | Italy |
| Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori | Meldola | Emilia-Romagna | 47014 | Italy |
| Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia | Ravenna | Emilia-Romagna | 48100 | Italy |
| Ospedale Infermi di Rimini | Rimini | Emilia-Romagna | 47900 | Italy |
| AOU Città della Salute e della Scienza di Torino - Presidio Le Molinette | Torino | Lazio | 10126 | Italy |
| Asst Papa Giovanni XXIII | Bergamo | Lombardy | 24100 | Italy |
| Azienda Ospedaliera Univ | Florence | Tuscany | 50141 | Italy |
| Derived |
| Younes A, Burke JM, Diefenbach C, Ferrari S, Khan C, Sharman JP, Tani M, Ujjani C, Vitolo U, Yuen S, Raval A, Shivhare M, Nielsen TG, Sellam G, Gilbertson M. Safety and efficacy of atezolizumab with obinutuzumab and bendamustine in previously untreated follicular lymphoma. Blood Adv. 2022 Oct 25;6(20):5659-5667. doi: 10.1182/bloodadvances.2021006131. |
| FG001 | Atezo-G-CHOP Cohort (Safety Run-In Phase) | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment. |
| FG002 | Atezo-R-CHOP Cohort (Expansion Phase) | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
| COMPLETED |
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| NOT COMPLETED |
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3 populations for the Atezo-G-Benda cohort: safety, efficacy, and pharmacokinetic (PK). All participants (n = 42) in Atezo-G-Benda cohort included in safety and positron emission tomography (PET) evaluable populations. Two participants were excluded from efficacy evaluable population due to diagnosis of relapsed/ refractory follicular lymphoma (r/r FL). All 42 FL participants in Atezo-G-Benda cohort included in PK evaluable population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. |
| BG001 | Atezo-G-CHOP Cohort (Safety Run-In Phase) | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment. |
| BG002 | Atezo-R-CHOP Cohort (Expansion Phase) | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria | Primary end point was positron emission tomography (PET) CR at EOI by IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [](streamdown:incomplete-link) | Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of relapsed/refractory [r/r] FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab). | Posted | Number | 90% Confidence Interval | percentage of participants | Up to approximately 6 months |
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| Primary | Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received. | Posted | Number | percentage of participants | Baseline up to approximately 4 years |
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| Secondary | Percentage of Participants With CR at EOI, as Determined by the Investigator Using Lugano 2014 Criteria | Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake \ | Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab). | Posted | Number | 90% Confidence Interval | percentage of participants | Up to approximately 6 months |
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| Secondary | Percentage of Participants With CR at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria | Complete response according to the modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. Partial Response (PR): at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. | Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab). | Posted | Number | 90% Confidence Interval | percentage of participants | Up to approximately 6 months |
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| Secondary | Percentage of Participants With CR at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria | Complete response according to modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. | Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab). | Posted | Number | 90% Confidence Interval | percentage of participants | Up to approximately 6 months |
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| Secondary | Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria | Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. | Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab). | Posted | Number | 90% Confidence Interval | percentage of participants | Up to approximately 6 months |
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| Secondary | Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria | Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. | Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab). | Posted | Number | 90% Confidence Interval | percentage of participants | Up to approximately 6 months |
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| Secondary | Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Lugano 2014 Criteria | Tumor response assessment was performed by IRC according to modified Lugano classification using PET/CT scan. OR defined as a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with/without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR: a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. | Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab). | Posted | Number | 90% Confidence Interval | percentage of participants | Up to approximately 6 months |
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| Secondary | Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Lugano 2014 Criteria | Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR: a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes & extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR with a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. | Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab). | Posted | Number | 90% Confidence Interval | percentage of participants | Up to approximately 6 months |
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| Secondary | Percentage of Participants With Best Response of CR or PR During Study, as Determined by Investigator Using Modified Cheson 2007 Criteria | CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. | All PET evaluable 1L FL and 1L DLBCL patients that received at least one dose of atezolizumab. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline up to approximately 4 years (assessed at Baseline, 6 to 8 weeks after Day [D] 1 of Cycle [Cy] 6 or 8 (1Cy: 21 or 28 days), then every 2 months up to 24 months, at 35 days of last dose, and at every 3 months post-treatment follow-up [up 4 years]) |
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| Secondary | Observed Serum Obinutuzumab Concentration | Predose time point was "any time prior to dose" for Cycle (Cy) 1 and "within 5 hour prior to dose" for other cycles (Cy 2,5,6) and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 milligrams per hour (mg/hour). If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. | All participants who received at least 1 dose of study treatment and who provided at least one pharmacokinetic (PK) sample. | Posted | Median | Full Range | ug/mL | Induction: Predose, 0.5 hour (h) postinfusion on Day (D) 1 of Cy1,2,5,6 (1Cy: 21/28 days); Maintenance: Predose, 0.5h postinfusion on Day 1 of Month 1,3,7,15,23; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years) |
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| Secondary | Observed Serum Atezolizumab Concentration | Atezo-G-Benda: Induction:Predose on D1 of Cy5,6 & D1,15 of Cy2,3 (1Cy:21/28 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years); Atezo-G-CHOP: Induction:Predose on D1 of Cy2,3,5,6 (1Cy:21 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,3,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years). Predose time point was "within 5 hour prior to dose" for Cy2,3,5,6 during induction phase and for Months 1 to 24 during maintenance phase. infusion length: 30-60 minutes. | All participants who received at least 1 dose of study treatment and who provided at least one pharmacokinetic (PK) sample. 0 represents no data was collected at that cycle. | Posted | Median | Full Range | ug/mL | Atezo-R-CHOP: Predose on D1 of Cy2,3,5,8,9,10,11,12,16,20,25 (1Cy:21 days), 0.5h postinfusion of D1 of Cy2,9; at 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years) |
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| Secondary | Observed Serum Rituximab Concentration | Predose time point was "any time prior to dose" for Cycle 1 and "within 5 hour prior to dose" for other cycles (Cycles 2,5,8) during induction phase and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 mg/hour. If no infusion-related or hypersensitivity reaction occurs, increase the infusion rate in 50 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. | All participants who received at least 1 dose of study treatment and who provided at least one PK sample. | Posted | Median | Full Range | ug/mL | Predose, 0.5h postinfusion on D1 of Cy1,2,5,8 (1Cy: 21 days); at 120 days and 1 year after last rituximab dose or at treatment discontinuation (up to 4 years) |
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| Secondary | Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab | Induction: Predose (any time prior to dose) on D1 of Cy1,5,6 (1Cy: 21/28 days); Maintenance: Predose (any time prior to dose) on D1 of Month 1; at 120 days and 1 year of last obinutuzumab dose or at treatment discontinuation (up to 4 years) | The safety analysis population consisted of all participants who received at least one dose of study drug in the Atezo-G-Benda cohort | Posted | Number | percentage of participants | Baseline up to approximately 4 years |
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| Secondary | Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab | Induction: Predose (any time prior to dose) on D1 of Cy1,5,8 (1Cy: 21 days); Maintenance: at 120 days and 1 year of last rituximab dose or at treatment discontinuation (up to 4 years) | The safety analysis population consisted of all participants who received at least one dose of study drug in the Atezo-R-CHOP cohort. | Posted | Number | percentage of participants | Baseline up to approximately 4 years |
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| Secondary | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab | Atezo-G-CHOP: Induction: Predose on D1 of Cy2,3,5,6 (1 Cy: 21 days); Maintenance: Predose on D1 of Month 1,2,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years); Atezo-R-CHOP: Predose on D1 of Cy 2,3,5,8,16,25 (1 Cy: 21 days); at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). Predose time point was "any time prior to dose" for Cycles 2,3,5,6,8 during induction phase, for Cycles 16,25 during consolidation treatment, and for Months 1 to 24 during maintenance phase. Atezo-G-Benda: Induction: Predose on D1 of Cy2,3,5,6 (1Cy: 28 days), Cy3D15: Predose; ; Maintenance: Predose on D1 of Month 1,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). The percentage of participants with positive results for ATAs to atezolizumab at baseline and at post-baseline time points are reported. | The analysis population consisted of all participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Baseline up to approximately 4 years |
|
Baseline up to approximately 4 years
The safety population is defined as all patients who received at least one dose of the study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases) | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab (G) and bendamustine during Cycle 1 (28-day cycle) and atezolizumab, obinutuzumab, and bendamustine during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (every other month [q2m]) for 24 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL received same treatment regimen as described for safety run-in phase. | 5 | 42 | 19 | 42 | 42 | 42 |
| EG001 | Atezo-G-CHOP Cohort (Safety Run-In Phase) | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment. | 1 | 7 | 2 | 7 | 7 | 7 |
| EG002 | Atezo-R-CHOP Cohort (Expansion Phase) | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. | 5 | 42 | 18 | 42 | 42 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AUTOIMMUNE HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ATRIAL TACHYCARDIA | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MYOCARDITIS | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HYPOACUSIS | Ear and labyrinth disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DIPLOPIA | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| IMMUNE-MEDIATED ENTEROCOLITIS | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| SUDDEN DEATH | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| EPSTEIN-BARR VIRUS INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| GASTROENTERITIS SALMONELLA | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| KIDNEY INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| PNEUMONIA INFLUENZAL | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| PNEUMONIA VIRAL | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION STAPHYLOCOCCAL | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| MIGRAINE | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| LARYNGEAL INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| OBLITERATIVE BRONCHIOLITIS | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| LYMPH NODE PAIN | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HYPOPHYSITIS | Endocrine disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| OCULAR HYPERAEMIA | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PHOTOPHOBIA | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DEFAECATION URGENCY | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DUODENAL ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| GLOSSITIS | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HAEMORRHOIDAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| RECTAL DISCHARGE | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| STEATORRHOEA | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| FEELING COLD | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PERIPHERAL SWELLING | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| SEASONAL ALLERGY | Immune system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| PHARYNGITIS STREPTOCOCCAL | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| VULVOVAGINAL MYCOTIC INFECTION | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| MENISCUS INJURY | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMATURIA | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| SKIN LACERATION | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| AMYLASE INCREASED | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| LIPASE INCREASED | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| JOINT EFFUSION | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ACROCHORDON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| OVARIAN EPITHELIAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| AMNESIA | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| BALANCE DISORDER | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| TASTE DISORDER | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DEVICE OCCLUSION | Product Issues | MedDRA v23.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MANIA | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| MICTURITION URGENCY | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| VAGINAL DISCHARGE | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
| |
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
| |
| VULVOVAGINAL PAIN | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HICCUPS | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PHARYNGEAL DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| UPPER-AIRWAY COUGH SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| RASH VESICULAR | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
| |
| PERIPHERAL COLDNESS | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
|
Development of the atezolizumab combination treatment was discontinued as there was insufficient evidence regarding the additive efficacy of this therapy.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Apr 26, 2021 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000069461 | Bendamustine Hydrochloride |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| C543332 | obinutuzumab |
| D011241 | Prednisone |
| D014750 | Vincristine |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment. |
| OG002 | Atezo-R-CHOP Cohort (Expansion Phase) | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
|
|
| OG001 | Atezo-R-CHOP Cohort (Expansion Phase) | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
|
|
| OG001 | Atezo-R-CHOP Cohort (Expansion Phase) | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
|
|
| OG001 | Atezo-R-CHOP Cohort (Expansion Phase) | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
|
|
| OG001 | Atezo-R-CHOP Cohort (Expansion Phase) | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
|
|
| OG001 | Atezo-R-CHOP Cohort (Expansion Phase) | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
|
|
| OG001 | Atezo-R-CHOP Cohort (Expansion Phase) | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
|
|
| OG001 | Atezo-R-CHOP Cohort (Expansion Phase) | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
|
|
| OG001 | Atezo-R-CHOP Cohort (Expansion Phase) | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
|
|
Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment. |
|
|
| OG001 | Atezo-R-CHOP Cohort (Expansion Phase) | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
| OG002 | Atezo-G-CHOP Cohort (Safety Run-In Phase) | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment. |
|
|
|
|
|
|
| OG001 | Atezo-G-CHOP Cohort (Safety Run-In Phase) | Safety run-in phase: Participants with previously untreated or relapsed or refractory FL received obinutuzumab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, obinutuzumab, and CHOP during Cycles 2-6, during induction treatment, followed by atezolizumab (once monthly) and obinutuzumab (q2m) for 24 months, during maintenance treatment. |
| OG002 | Atezo-R-CHOP Cohort (Expansion Phase) | Participants with previously untreated DLBCL received rituximab and CHOP during Cycle 1 (21-day cycle) and atezolizumab, rituximab, and CHOP during Cycles 2-8 (atezolizumab and rituximab for 8 cycles and CHOP for either 6 or 8 cycles, as determined by the investigator), during induction treatment, followed by atezolizumab from Cycles 9-25 during consolidation treatment. |
|
|