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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004845-25 | EudraCT Number |
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This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of obinutuzumab + Atezo + Pola in participants with relapsed or refractory (RR) FL and rituximab + Atezo + Pola in participants with RR DLBCL. The study will include an initial dose-escalation phase designed to determine the recommended Phase 2 dose (RP2D) for Pola in this treatment combination, followed by an expansion phase in which Pola will be given at the RP2D. All participants will receive induction treatment with obinutuzumab + Atezo + Pola for 6 cycles. RR FL participants achieving a complete response (CR), partial response (PR), or stable disease (SD) at the end of induction (EOI) will receive maintenance treatment with obinutuzumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-Escalation Phase | Experimental | During the induction treatment Cycle 1 (21-day cycles): participants will receive obinutuzumab on Days 1, 8, and 15 and Pola on Day 1; Cycles 2-6: participants will receive obinutuzumab on Day 1, Atezo on Day 1, and Pola on Day 1. This is followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. |
|
| Expansion Phase | Experimental | For FL during the induction treatment Cycle 1 (21-day cycles): participants will receive obinutuzumab on Days 1, 8, and 15 and Pola at identified RP2D (decided from dose-escalation phase) on Day 1; Cycles 2-6: participants will receive obinutuzumab on Day 1 and Pola at RP2D on Day 1. This is followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months (during maintenance treatment for FL participants). |
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| Safety Run-In Phase | Experimental | For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants will receive rituximab on Day 1 and Pola on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab [TECENTRIQ] | Drug | Atezolizumab will be administered by intravenous (IV) infusion at a flat dose of 1200 milligram (mg) every 3 weeks (Q3W) on Day 1 of Cycles 2-6, given in 21-day cycles during induction treatment. NOTE: Atezolizumab treatment has been discontinued in all participants currently on study treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With CR at EOI, as Determined by the Investigator on the Basis of Positron Emission Tomography and Computed Tomography (PET-CT) Scan | 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 \ | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With CR at EOI, as Determined by Investigator on the Basis of CT Scans Alone | Tumor response assessment was performed by investigator according to modified Lugano classification using computed tomography (CT) scan. OR: a response of CR or PR. CR: Target nodes/nodal masses regressed to <= 1.5 cm in LDi; no extralymphatic sites of disease; organ enlargement regressed to normal; no new lesions; normal/IHC-negative bone marrow morphology. All CT evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. |
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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 |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States | ||
| University Miami |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35182224 | Derived | Topp MS, Eradat H, Florschutz A, Hochhaus A, Wrobel T, Walewski J, Knopinska-Posluszny W, Kanate AS, Lech-Maranda E, Brunnberg U, Chitra S, Nielsen TG, Sellam G, Shivhare M, Lossos IS. Anti-CD20-atezolizumab-polatuzumab vedotin in relapsed/refractory follicular and diffuse large B-cell lymphoma. J Cancer Res Clin Oncol. 2023 Feb;149(2):811-817. doi: 10.1007/s00432-021-03847-5. Epub 2022 Feb 18. |
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The study was conducted at 11 investigational centres in Germany (3), Poland (5) and USA (3).
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose-Escalation FL Cohort 1.4 mg | During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. |
| 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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| Obinutuzumab | Drug | Obinutuzumab will be administered by IV infusion at a flat dose of 1000 mg on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-6, given in 21-day cycles during induction treatment, and on Day 1 of every other month during maintenance treatment (1 cycle=21 days; infusion rate starts at 50 mg/hour (hr) and increases every 30 min to a maximum of 400 mg/hr). |
|
| Polatuzumab Vedotin | Drug | Polatuzumab vedotin will be administered by IV infusion. For relapsed or refractory FL either 1.4 mg/kilogram (kg) or 1.8 mg/kg (dose-escalation phase) and at RP2D (dose-expansion phase) on Day 1 of Cycles 1-6 will be given in 21-day cycles during induction treatment. For relapsed or refactory DLBCL, 1.8 mg/kg will be given during run-in phase and either 1.8 mg/kg or 1.4 mg/kg during the expansion phase (1 cycle=21 days; infusion rate starts with 90 min and decreases to 30 min). |
|
| Rituximab | Drug | Rituximab will be administered by IV infusion at 375 mg/m˄2 on Day 1 of Cycles 1-6 during induction treatment (1 cycle-21 days; infusion rate starts with 50 mg/hr and increases every 30 min to a maximum of 400 mg/hr). |
|
| Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months) |
| Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of PET-CT Scans | 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 PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months) |
| Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of CT Scans Alone | Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. OR: a response of CR or PR. CR: Target nodes/nodal masses regressed to <= 1.5 cm in LDi; no extralymphatic sites of disease; organ enlargement regressed to normal; no new lesions; normal/IHC-negative bone marrow morphology. PR with >= 50 percet decrease in SPD of up to six target measurable nodes and extranodal sites, a 5 mm x 5 mm default value when lesions were too small, 0 x0 mm value when lesions were no longer visible, actual measurements were used for nodes greater than 5 mm x 5 mm for lymph nodes & extralymphatic sites; absent/normal, regression for non-measured lesion; spleen enlargement regression by > 50 percent; no new lesions; reduced residual uptake in bone marrow compared to baseline. All CT evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months) |
| Percentage of Participants With Best Response of CR or PR During the Study, as Determined by the Investigator on the Basis of CT Scans Alone | Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. OR: a response of CR or PR. CR: Target nodes/nodal masses regressed to <= 1.5 cm in LDi; no extralymphatic sites of disease; organ enlargement regressed to normal; no new lesions; normal/IHC-negative bone marrow morphology. PR with >= 50 percet decrease in SPD of up to six target measurable nodes and extranodal sites, a 5 mm x 5 mm default value when lesions were too small, 0 x0 mm value when lesions were no longer visible, actual measurements were used for nodes greater than 5 mm x 5 mm for lymph nodes & extralymphatic sites; absent/normal, regression for non-measured lesion; spleen enlargement regression by > 50 percent; no new lesions; reduced residual uptake in bone marrow compared to baseline. All CT evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. | Baseline up to 35 months |
| Percentage of Participants With Adverse Events and Serious Adverse Events | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the treatment. An adverse event was therefore any unfavourable 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. Grading was completed according to the CTCAE, version 4.0 for severity and tumor flare reactions were graded according to NCI CTCAE v3.0. | Baseline up to 35 months |
| Serum Obinutuzumab Concentration | pre-dose (0 hr), 30 min after EOI on Day 1 Cycle 1; pre-dose (within 5 hr), 30 min after EOI on Day 1 of Cycles 2, 4, 6; maintenance phase: pre-dose (within 5 hr) on Day 1 of Months 1, 7, 13, 19; anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 50 mg/hr and decreases every 30 min to maximum of 400 mg/hr) | Pre-dose (0 hr) up to 35 months |
| Serum Rituximab Concentration | pre-dose (0 hr), 30 min after EOI on Day 1 Cycle 1; pre-dose (within 5 hr) on Day 1 of Cycles 2, 4; pre-dose (within 5 hr), 30 min after EOI on Day 1 of Cycle 6; anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 50 mg/hr and increases every 30 min to maximum of 400 mg/hr) | Pre-dose (0 hr) up to 35 months |
| Serum Atezo Concentration | pre-dose (within 5 hr), 30 min after EOI on Day 1 of Cycles 2, 3, 4; pre-dose (within 5 hr) on Day 1 of Cycle 6; maintenance phase: pre-dose (within 5 hr) on Day 1 of Month 1; 30 min after EOI on Day 2 of Month 1; pre-dose (within 5 hr) on Day 1 of Month 4, 7, 13, 19; anytime during treatment discontinuation visit, 120 days after the last dose, and 1-2 years after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 60 min and decreases to 30 min) | Pre-dose (0 hr) up to 35 months |
| Serum Pola Concentration | pre-dose (0 hr) on Day 1 Cycle 1; pre-dose (within 5 hr) on Day 1 of Cycles 2, 4; maintenance phase: pre-dose (within 5 hr) on Day 1 of Months 1; anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 90 min and decreases to 30 min) | Pre-dose (0 hr) up to 35 months |
| Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab | Pre-dose (0 hr) on Day 1 of Cycle 1, 6, anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 50 mg/hr and increased every 30 min to maximum of 400 mg/hr) | Baseline up to 35 months |
| Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab | Pre-dose (0 hr) on Day 1 of Cycle 1, 2, 4, 6, anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 50 mg/hr and increased every 30 min to maximum of 400 mg/hr) | Baseline to 35 months |
| Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezo | Pre-dose (0 hr) on Day 1 of Cycle 2, 3, 4, 6, Month 1, 4, 7, 13 and 19, anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 60 min and decreases to 30 min) | Baseline to 35 months |
| Percentage of Participants With ATAs to Pola | Pre-dose (0 hr) on Day 1 of Cycle 1, 2, 4, anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 90 min and decreases to 30 min) | Baseline to 35 months |
| Miami |
| Florida |
| 33136 |
| United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| Columbia Basin Hem-Onc; Department Hematology Oncology | Kennewick | Washington | 99336 | United States |
| Robert Byrd Health Science; Dept of Medicine, Section of Hematology/Oncology | Morgantown | West Virginia | 26506 | United States |
| Städtisches Klinikum Dessau Klinik für Innere Medizin Abt. Intensivmedizin | Dessau | 06847 | Germany |
| Uniklinik Essen | Essen | 45122 | Germany |
| Universitatsklinikum Frankfurt | Frankfurt | 60590 | Germany |
| Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik | Greifswald | 17475 | Germany |
| Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie | Hanover | 30625 | Germany |
| Universitätsklinikum Jena Klinik f.Chirurgie Abt. Allgemein- und Viszeralchirurgie | Jena | 07747 | Germany |
| Klinikum rechts der Isar der Technischen Universität München | München | 81675 | Germany |
| Universitätsklinikum Würzburg | Würzburg | 97080 | Germany |
| Szpitale Wojewodzkie w Gdyni Sp. z o.o. | Gdynia | 81-519 | Poland |
| Wojewódzki Szpital Specjalistyczny im.MikołajaKopernika;KlinikaHematologiiUniwersytetuMedycznego | Lodz | 9351 | Poland |
| MTZ Clinical Research Sp. z o.o. | Warsaw | 02-106 | Poland |
| Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych | Warsaw | 02-776 | Poland |
| Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego | Warsaw | 02-781 | Poland |
| Medical Uni of Wroclaw; Hematology | Wroclaw | 50-367 | Poland |
| FG001 | Dose-Escalation and Expansion FL Cohort 1.8 mg | During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. |
| FG002 | Safety Run-in and Expansion DLBCL Cohort | For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose-Escalation FL Cohort 1.4 mg | During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. |
| BG001 | Dose-Escalation and Expansion FL Cohort 1.8 mg | During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. |
| BG002 | Safety Run-in and Expansion DLBCL Cohort | For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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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| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | 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 CR at EOI, as Determined by the Investigator on the Basis of Positron Emission Tomography and Computed Tomography (PET-CT) Scan | 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 \ | Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available. | Posted | Number | Percentage of participants | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months) |
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| Secondary | Percentage of Participants With CR at EOI, as Determined by Investigator on the Basis of CT Scans Alone | Tumor response assessment was performed by investigator according to modified Lugano classification using computed tomography (CT) scan. OR: a response of CR or PR. CR: Target nodes/nodal masses regressed to <= 1.5 cm in LDi; no extralymphatic sites of disease; organ enlargement regressed to normal; no new lesions; normal/IHC-negative bone marrow morphology. All CT evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. | Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available. | Posted | Number | Percentage of participants | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months) |
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| Secondary | Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of PET-CT Scans | 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 PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population | Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available | Posted | Number | Percentage of participants | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months) |
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| Secondary | Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of CT Scans Alone | Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. OR: a response of CR or PR. CR: Target nodes/nodal masses regressed to <= 1.5 cm in LDi; no extralymphatic sites of disease; organ enlargement regressed to normal; no new lesions; normal/IHC-negative bone marrow morphology. PR with >= 50 percet decrease in SPD of up to six target measurable nodes and extranodal sites, a 5 mm x 5 mm default value when lesions were too small, 0 x0 mm value when lesions were no longer visible, actual measurements were used for nodes greater than 5 mm x 5 mm for lymph nodes & extralymphatic sites; absent/normal, regression for non-measured lesion; spleen enlargement regression by > 50 percent; no new lesions; reduced residual uptake in bone marrow compared to baseline. All CT evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. | Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available | Posted | Number | Percentage of participants | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months) |
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| Secondary | Percentage of Participants With Best Response of CR or PR During the Study, as Determined by the Investigator on the Basis of CT Scans Alone | Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. OR: a response of CR or PR. CR: Target nodes/nodal masses regressed to <= 1.5 cm in LDi; no extralymphatic sites of disease; organ enlargement regressed to normal; no new lesions; normal/IHC-negative bone marrow morphology. PR with >= 50 percet decrease in SPD of up to six target measurable nodes and extranodal sites, a 5 mm x 5 mm default value when lesions were too small, 0 x0 mm value when lesions were no longer visible, actual measurements were used for nodes greater than 5 mm x 5 mm for lymph nodes & extralymphatic sites; absent/normal, regression for non-measured lesion; spleen enlargement regression by > 50 percent; no new lesions; reduced residual uptake in bone marrow compared to baseline. All CT evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. | Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available | Posted | Number | Percentage of participants | Baseline up to 35 months |
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| Secondary | Percentage of Participants With Adverse Events and Serious Adverse Events | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the treatment. An adverse event was therefore any unfavourable 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. Grading was completed according to the CTCAE, version 4.0 for severity and tumor flare reactions were graded according to NCI CTCAE v3.0. | The Safety Evaluable Population that includes patients who received at least one dose of any study treatment. | Posted | Number | Percentage of participants | Baseline up to 35 months |
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| Secondary | Serum Obinutuzumab Concentration | pre-dose (0 hr), 30 min after EOI on Day 1 Cycle 1; pre-dose (within 5 hr), 30 min after EOI on Day 1 of Cycles 2, 4, 6; maintenance phase: pre-dose (within 5 hr) on Day 1 of Months 1, 7, 13, 19; anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 50 mg/hr and decreases every 30 min to maximum of 400 mg/hr) | The Safety Evaluable Population that includes patients who received at least one dose of any study treatment. | Posted | Mean | Standard Deviation | mcg/mL | Pre-dose (0 hr) up to 35 months |
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| Secondary | Serum Rituximab Concentration | pre-dose (0 hr), 30 min after EOI on Day 1 Cycle 1; pre-dose (within 5 hr) on Day 1 of Cycles 2, 4; pre-dose (within 5 hr), 30 min after EOI on Day 1 of Cycle 6; anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 50 mg/hr and increases every 30 min to maximum of 400 mg/hr) | The Safety Evaluable Population that includes patients who received at least one dose of any study treatment. | Posted | Mean | Standard Deviation | mcg/mL | Pre-dose (0 hr) up to 35 months |
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| Secondary | Serum Atezo Concentration | pre-dose (within 5 hr), 30 min after EOI on Day 1 of Cycles 2, 3, 4; pre-dose (within 5 hr) on Day 1 of Cycle 6; maintenance phase: pre-dose (within 5 hr) on Day 1 of Month 1; 30 min after EOI on Day 2 of Month 1; pre-dose (within 5 hr) on Day 1 of Month 4, 7, 13, 19; anytime during treatment discontinuation visit, 120 days after the last dose, and 1-2 years after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 60 min and decreases to 30 min) | The Safety Evaluable Population that includes patients who received at least one dose of any study treatment. | Posted | Mean | Standard Deviation | mcg/mL | Pre-dose (0 hr) up to 35 months |
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| Secondary | Serum Pola Concentration | pre-dose (0 hr) on Day 1 Cycle 1; pre-dose (within 5 hr) on Day 1 of Cycles 2, 4; maintenance phase: pre-dose (within 5 hr) on Day 1 of Months 1; anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 90 min and decreases to 30 min) | The Safety Evaluable Population that includes patients who received at least one dose of any study treatment. | Posted | Mean | Standard Deviation | mcg/mL | Pre-dose (0 hr) up to 35 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab | Pre-dose (0 hr) on Day 1 of Cycle 1, 6, anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 50 mg/hr and increased every 30 min to maximum of 400 mg/hr) | The Safety Evaluable Population that includes patients who received at least one dose of any study treatment. | Posted | Number | Percentage of participants | Baseline up to 35 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab | Pre-dose (0 hr) on Day 1 of Cycle 1, 2, 4, 6, anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 50 mg/hr and increased every 30 min to maximum of 400 mg/hr) | The Safety Evaluable Population that includes patients who received at least one dose of any study treatment. (FL cohorts not applicable as rituximab was only administered in the Safety Run- in phase). | Posted | Number | Percentage of participants | Baseline to 35 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezo | Pre-dose (0 hr) on Day 1 of Cycle 2, 3, 4, 6, Month 1, 4, 7, 13 and 19, anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 60 min and decreases to 30 min) | The Safety Evaluable Population for this outcome measure includes participants in the DLBCL cohort who received at least one dose of any study treatment. Participants in the FL 1.4 mg and FL 1.8 mg were not anazlyed. | Posted | Number | Percentage of participants | Baseline to 35 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With ATAs to Pola | Pre-dose (0 hr) on Day 1 of Cycle 1, 2, 4, anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 90 min and decreases to 30 min) | The Safety Evaluable Population that includes patients who received at least one dose of any study treatment. | Posted | Number | Percentage of participants | Baseline to 35 months |
|
From randomization up to 35 months
All adverse events that occurred on or after the first dose of study treatment are summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute Common Terminology Criteria (NCI CTCAE) v4.0 grade. All-Cause Mortality is reported for the ITT population.
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 | Dose-Escalation FL Cohort 1.4 mg | During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 milligram (mg) of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and 1.4 mg/kilogram (kg) of pola on Day 1. The 1.4 mg/kg dose was cleared by an Internal Monitoring Committee (IMC) review and escalated to 1.8 mg/kg. This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | Dose-Escalation and Expansion FL Cohort 1.8 mg | During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. | 2 | 10 | 4 | 10 | 10 | 10 |
| EG002 | Safety Run-in and Expansion DLBCL Cohort | For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. | 13 | 23 | 2 | 21 | 15 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA version 22.1 | Systematic Assessment |
| |
| GUILLAIN-BARRE SYNDROME | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA version 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| ANAEMIA FOLATE DEFICIENCY | Blood and lymphatic system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| SINUS TACHYCARDIA | Cardiac disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| AUTOIMMUNE THYROIDITIS | Endocrine disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| GLAUCOMA | Eye disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| SCLERITIS | Eye disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| FACE OEDEMA | General disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| INFUSION SITE EXTRAVASATION | General disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| OEDEMA | General disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| PERIPHERAL SWELLING | General disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| BACTERIAL INFECTION | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| CYTOMEGALOVIRUS INFECTION | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| LARYNGITIS | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| ORAL FUNGAL INFECTION | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| PELVIC ABSCESS | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA version 22.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 22.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA version 22.1 | Systematic Assessment |
| |
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA version 22.1 | Systematic Assessment |
| |
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA version 22.1 | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA version 22.1 | Systematic Assessment |
| |
| LIPASE INCREASED | Investigations | MedDRA version 22.1 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA version 22.1 | Systematic Assessment |
| |
| PROCALCITONIN INCREASED | Investigations | MedDRA version 22.1 | Systematic Assessment |
| |
| THYROXINE DECREASED | Investigations | MedDRA version 22.1 | Systematic Assessment |
| |
| TRI-IODOTHYRONINE DECREASED | Investigations | MedDRA version 22.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA version 22.1 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA version 22.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| FLUID RETENTION | Metabolism and nutrition disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| SACROILIITIS | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| FACIAL PARALYSIS | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| POLYNEUROPATHY | Nervous system disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| HICCUPS | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| LARYNGEAL OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| PULMONARY THROMBOSIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| THROMBOSIS | Vascular disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| CATARACT NUCLEAR | Eye disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| VITREOUS DEGENERATION | Eye disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| ACUTE SINUSITIS | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| CONJUNCTIVITIS VIRAL | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
| |
| TENDONITIS | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA version 22.1 | Systematic Assessment |
|
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 |
| Sep 10, 2020 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| 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 |
| C543332 | obinutuzumab |
| C000600736 | polatuzumab vedotin |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| 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 |
|
| White |
|
During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. |
| OG002 | Safety Run-In Phase | For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. |
|
|
| OG001 | Dose-Escalation and Expansion FL Cohort 1.8 mg | During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. |
| OG002 | Safety Run-In Phase | For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. |
|
|
| OG001 | Dose-Escalation and Expansion FL Cohort 1.8 mg | During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. |
| OG002 | Safety Run-In Phase | For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. |
|
|
| OG001 | Dose-Escalation and Expansion FL Cohort 1.8 mg | During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. |
| OG002 | Safety Run-In Phase | For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. |
|
|
During the induction treatment Cycle 1 (21-day cycles): participants received obinutuzumab on Days 1, 8, and 15 and pola on Day 1; Cycles 2-6: participants received 1000 mg of obinutuzumab on Day 1, 1200 mg of atezo on Day 1, and pola was escalated to 1.8 mg/kg (on Day 1); once cleared by the IMC it was declared as the recommended phase 2 dose (RP2D). This was followed by obinutuzumab on Day 1 of every other month starting with Month 1 for 24 months, during maintenance treatment for FL participants. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed.
| OG002 | Safety Run-In Phase | For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. |
|
|
|
|
|
| OG002 | Safety Run-In Phase | For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. |
|
|
| OG002 | Safety Run-In Phase | For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. |
|
|
|
|
|
| OG002 | Safety Run-In Phase | For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. |
|
|
| OG002 | Safety Run-In Phase | For DLBCL, during the induction treatment Cycles 1-6 (21-day cycles): participants received a 375 mg/m^2 IV of rituximab on Day 1 and on Day 1 of every other month during consolidation. Participants also received a 1.8 mg/kg IV of Pola on Day 1. Cycles 2-6: participants received 1200 mg of Atezo on Day 1. Due to unexpected toxicity, recruitment was stopped, and atezolizumab discontinued in all treated patients. This combination will not be further developed. |
|
|