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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002904-15 | EudraCT Number |
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Study was terminated due to closure of study arms following futility analysis and difficulty in enrolling participants due to evolving treatment landscape
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| Name | Class |
|---|---|
| EMD Serono | INDUSTRY |
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Study B9991011 is a multi-center, international, randomized, open label, 2 component (Phase 1b followed by Phase 3), parallel-arm study of avelumab in combination with various agents for the treatment of Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL).
The target study population of this Phase 1b/3 registrational study is patients with R/R DLBCL who have completed at least 2 (but not more than 4) lines of prior rituximab-containing multi-agent chemotherapy, and/or in whom autologous stem cell transplant (ASCT) has failed, or who are not candidates for ASCT or who are not eligible for intensive chemotherapy. Patients who are ineligible for intensive second line chemotherapy must have received at least one prior rituximab-containing combination chemotherapy regimen. The study will assess the safety, efficacy, pharmacokinetics (PK), immunogenicity of the 3 avelumab-based combination regimens tested, and collect patient reported outcome (PRO) data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b Arm A | Experimental | avelumab/utomilumab/rituximab |
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| Phase 1b Arm B | Experimental | avelumab/utomilumab/azacitidine |
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| Phase 1b Arm C | Experimental | avelumab/rituximab/bendamustine |
|
| Phase 3 Arm D (selected from Phase 1b) | Experimental | Selected regimen from Phase 1b component which may be i) avelumab/utomilumab/rituximab OR ii) avelumab/rituximab/azacitidine OR iii) avelumab/rituximab/bendamustine |
|
| Phase 3 Arm E | Active Comparator | Investigator's Choice of either rituximab/bendamustine or rituximab/gemcitabine/oxaliplatin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelumab | Biological | Investigational fully human anti-PD-L1 monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLT) | AEs occurring in first 4 weeks of treatment,attributable to 1 of study drugs. Hematology:1)Grade 4 neutropenia,2)Grade >=3 febrile neutropenia with single temperature of >38.3 degrees Celsius (C)/sustained temperature of >=38.0 degrees C for more than 1 hour with/without associated sepsis,3)Grade >=3 neutropenic infection,4)Grade 4 thrombocytopenia/Grade 3 thrombocytopenia with clinically significant bleeding,5)Grade 4 anemia 6)Any grade >=3 non-hematology toxicity except:transient Grade 3 flu like symptoms/fever controlled with standard medical management;transient Grade 3 fatigue,localized skin reactions/headache that resolves to Grade <=1;Grade 3 nausea,vomiting/diarrhea resolved to Grade <=1 in ˂72 hours after initiation of adequate medical management;Grade 3 skin toxicity resolved to Grade <=1 in ˂7 days;tumor flare;Single laboratory values that are out of normal range,that have no clinical correlate and resolve to Grade <=1 within 7 days with adequate medical management. | Day 1 Cycle 1 up to 4 Weeks |
| Objective Response Rate (ORR) as Assessed by Investigator Per Lugano Response Classification Criteria | ORR was defined as percentage of participants with complete response (CR) or partial response (PR), as assessed by investigator per lugano response classification criteria. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [<=] mediastinum), or 3 (uptake less than [<] mediastinum but <=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. PR was defined as >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in sum of products of diameters (SPD) of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. | Randomization until date of PD, start of new anticancer therapy, discontinuation from study or death due to any cause, whichever occurred first (maximum up to 36 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Greater Than or Equal to (>=) Grade 3, As Per National Cancer Institute Common Terminology Criteria For Adverse Events (NCI-CTCAE), Version 4.03 | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03,severity was graded as Grade 1:asymptomatic/mild symptoms,clinical/diagnostic observations only, intervention not indicated; Grade 2:moderate, minimal, local/noninvasive intervention indicated,limiting age-appropriate instrumental activities of daily life (ADL); Grade 3:severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4:life-threatening consequence, urgent intervention indicated; Grade 5:death related to AE. TEAE was defined as events which occurred during on-treatment period beginning with first dose of study treatment through minimum (30 days + last dose of study treatment or start of new anti-cancer drug therapy). In this outcome measure participant with any TEAE of Grade 3 or above are reported. |
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Key Inclusion Criteria:
-Any of the following as defined by the WHO, 2016 lymphoid neoplasm classifications and histologically confirmed:
Relapsed or refractory disease following at least 2 lines (and a maximum of 4 lines) of prior rituximab containing multi-agent chemotherapy which may include an autologous stem cell transplantation unless patients are not considered suitable for intensive second-line chemotherapy or autologous stem cell transplantation. Patients who are ineligible for intensive second line chemotherapy,must have received at least one prior rituximab-containing combination chemotherapy regimen. Patients who are ineligible for intensive second line chemotherapy, must have received at least one prior rituximab-containing combination chemotherapy regimen.
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Norton Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34687398 | Derived | Hawkes EA, Phillips T, Budde LE, Santoro A, Saba NS, Roncolato F, Gregory GP, Verhoef G, Offner F, Quero C, Radford J, Giannopoulos K, Stevens D, Thall A, Huang B, Laird AD, Sandner R, Ansell SM. Avelumab in Combination Regimens for Relapsed/Refractory DLBCL: Results from the Phase Ib JAVELIN DLBCL Study. Target Oncol. 2021 Nov;16(6):761-771. doi: 10.1007/s11523-021-00849-8. Epub 2021 Oct 23. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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This study was planned to be conducted into two phases: Phase 1b and Phase 3. Phase 3 of the study was never conducted due to early termination of study because of Phase 1b enrollment closure.
This study included participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after completion of at least 2 and not more than 4 lines of rituximab-containing multi-agent chemotherapy (prior to this study), and/or in whom autologous stem cell transplant (ASCT) has failed, or who were not candidates for ASCT or who were not eligible for intensive chemotherapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Avelumab+Rituximab+Utomilumab | Avelumab 10 milligram per kilogram (mg/kg) intravenous (IV) infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 milligram per meter square (mg/m^2) IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days. |
| 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 | Yes | No | No | Study Protocol | Dec 11, 2017 | Nov 20, 2020 |
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|
| Utomilumab | Biological | Investigational, fully human IgG2 CD 137/4-1BB agonist |
|
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| Rituximab | Biological | CD20-directed cytolytic antibody |
|
|
| Azacitidine | Other | Antimetabolite antineoplastic agent and demethylation agent. |
|
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| Bendamustine | Drug | Alkylating drug |
|
|
| Gemcitabine | Drug | Nucleoside analogue |
|
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| Oxaliplatin | Drug | Platinum-based drug |
|
|
| From first dose of study treatment up to at least 30 days after the last dose of study treatment or initiation of new anti-cancer therapy (up to 36 months) |
| Number of Participants With Laboratory Abnormalities As Per National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Laboratory parameters included hematological and biochemistry: Hematological parameters included: anemia, haemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cells decreased. Biochemistry parameters included alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholesterol high, creatine kinase(cpk) increased, creatinine increased, gamma glutamyl transferase(ggt) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, lipase increased,serum amylase increased.Test abnormalities were graded by NCI CTCAE version 4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening. Number of participants with abnormalities of any grade were reported. | From first dose of study treatment up to at least 30 days after the last dose of study treatment or initiation of new anti-cancer therapy (up to 36 months) |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (>) 30 millisecond (ms) or 60 ms; absolute value >450 ms, >480 ms and >500 ms; 2) heart rate (HR): absolute value <=50 beats per minute (bpm) and decrease from baseline >=20 bpm; absolute value >=120 bpm and increase from baseline >=20 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS interval: absolute value >=120 ms. | From first dose of study treatment up to at least 30 days after the last dose of study treatment or initiation of new anti-cancer therapy (up to 36 months) |
| Duration of Response (DOR) as Assessed by Investigator Per Lugano Response Classification Criteria | Investigator assessed DOR: was defined for participants with OR as time from first documentation of OR to time of first documentation of disease progression/death due to any cause, whichever occurred first. CR: 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. PR: >=50% decrease in SPD of up to 6 of largest dominant lymph nodes,no increase in size of other nodes,liver,spleen volume,>=50% decrease in SPD of hepatic splenic nodules,absence of other organ involvement,no new sites of disease. PD: appearance of new lesion more than 1.5 cm in any axis,at least a 50% increase from nadir in SPD/longest diameter of previous lesion/node. Data was censored on date of last adequate tumor assessment in participants with no event,started new anti-cancer therapy/had 2 or more missing assessments. | First response (CR or PR) to date of PD, start of new anti-cancer therapy, discontinuation from the study, censoring date or death due to any cause, whichever occurred first (maximum up to 36 months) |
| Time to Tumor Response (TTR) as Assessed by Investigator Per Lugano Response Classification Criteria | TTR was defined for participants who achieved objective response as time from randomization to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as 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 and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow. PR was defined as >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. | From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to 36 months) |
| Disease Control Rate as Assessed by the Investigator Per Lugano Response Classification Criteria | Disease control rate was defined as percentage of participants with disease control. Disease Control (DC) was defined as the best overall response of CR, PR, or stable disease (SD). CR: score of 1 (no uptake above background), 2 (uptake <= mediastinum), or 3 (uptake less than <mediastinum but <=liver) with or 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. PR: >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. SD: <50% decrease in SDP of up to 6 dominant, measurable nodes and extranodal sites; no criteria for progressive disease met. To qualify as a best overall response of SD, at least one SD assessment must be observed >=6 weeks after start date and before disease progression. | From the date of randomization to the first documentation of PD, study discontinuation, start of new anti-cancer therapy or death due to any cause, whichever occurred first (maximum up to 36 months) |
| Progression-Free Survival (PFS) as Assessed by the Investigator Per Lugano Response Classification Criteria | Investigator assessed PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. PFS data was censored on the date of the last adequate tumor assessment for participants who had no an event (PD or death), for participants who start a new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing or inadequate post-baseline tumor assessment. Participants without an adequate baseline or post-baseline tumor assessment were censored on the date of randomization unless death occurred on or before the time of the second planned tumor assessment in which case the death was considered as an event. | From the date of randomization to progression of disease, study discontinuation, censoring date or death due to any cause, whichever occurred first (up to 36 months) |
| Overall Survival | Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method. | From the date of randomization to discontinuation from the study or death, whichever occurred first (maximum up to 36 months) |
| Concentration Verses Time Summary of Avelumab | 1 hour Post dose Day 2 Cycle 1, 144 hour Post dose Day 8 of Cycle 1, 0 hour Post dose Day 16 of Cycle 1, Day 1 of Cycle 4 and Cycle 6 |
| Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status | ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. | Baseline: 2 hours pre-dose of first dose of avelumab, Post baseline: post first dose up to up to 30 Days after the end of treatment (maximum up to 36 months) |
| Number of Participants With Anti-Drug Antibodies (ADA) Against Rituximab by Never and Ever Positive Status | ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. | From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months) |
| Number of Participants With Anti-Drug Antibodies (ADA) Against Utomilumab by Never and Ever Positive Status | ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. | From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months) |
| Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status | nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point. | From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months) |
| Number of Participants With Neutralizing Antibodies (nAb) Against Rituximab by Never and Ever Positive Status | nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point. | From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months) |
| Number of Participants With Neutralizing Antibodies (nAb) Against Utomilumab by Never and Ever Positive Status | nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point. | From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months) |
| Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor and Immune Cells as Assessed by Immunohistochemistry (IHC) at Baseline | Percentage of Tumor and Immune Cells as Assessed by Immunohistochemistry at Baseline. | Screening (prior to first dose of study treatment) |
| Number of Participants With Minimal Residual Disease Burden (MRD) Positive, Negative and Not Evaluable (NE) Status | Number of participants with MRD positive, negative and not evaluable status were reported in this outcome measure. | Baseline, Day 1 of Cycle 3, 6, 9, 12 and 18 |
| Louisville |
| Kentucky |
| 40207 |
| United States |
| Norton Diagnostic Center - Dupont | Louisville | Kentucky | 40207 | United States |
| Norton Women's and Children's Hospital | Louisville | Kentucky | 40207 | United States |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | United States |
| Parexel International | Billerica | Massachusetts | 01821 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| North Shore Hematology Oncology Associates | East Setauket | New York | 11733 | United States |
| St. George Hospital | Kogarah | New South Wales | 2217 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Cancer Clinical Trials Centre, Austin Health, Level 4 | Heidelberg | Victoria | 3084 | Australia |
| Genesis Care | Heidelberg | Victoria | 3084 | Australia |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Farmacia Studi Clinici | Rozzano | MI | 20089 | Italy |
| Istituto Clinico Humanitas | Rozzano | MI | 20089 | Italy |
| Malopolskie Centrum Medyczne S.C. | Krakow | Lesser Poland Voivodeship | 30-510 | Poland |
| Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli | Lublin | Lublin Voivodeship | 20-090 | Poland |
| Nzoz McD Voxel Osrodek Pet-Tk-Nmr | Krakow | 30-006 | Poland |
| Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli Oddzial Hematologiczny | Lublin | 20-090 | Poland |
| NU-MED Centrum Diagnostyki i Terapii Onkologicznej Zamosc Sp. z o.o. | Zamość | 22-400 | Poland |
| Samsung Medical Center Clinical Trial Pharmacy | Seoul | 06351 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital San Pedro de Alcantara | Cáceres | 10003 | Spain |
| Centro de Investigación Medicina Especializada Sanitaria (CIMES) | Málaga | 29010 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| The Christie Pathology Partnership | Manchester | M20 4BX | United Kingdom |
| FG001 | Avelumab+Azacitidine+Utomilumab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Azacitidine 40 mg/m^2 subcutaneous (SC) dose was administered on Days 1 to 5 of each treatment cycle until the participant no longer received clinical benefit, along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days. |
| FG002 | Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. |
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Avelumab+Rituximab+Utomilumab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days. |
| BG001 | Avelumab+Azacitidine+Utomilumab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Azacitidine 40 mg/m^2 SC dose was administered on Days 1 to 5 of each treatment cycle until the participant no longer received clinical benefit, along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days. |
| BG002 | Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. |
| 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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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | Number of Participants With Dose Limiting Toxicities (DLT) | AEs occurring in first 4 weeks of treatment,attributable to 1 of study drugs. Hematology:1)Grade 4 neutropenia,2)Grade >=3 febrile neutropenia with single temperature of >38.3 degrees Celsius (C)/sustained temperature of >=38.0 degrees C for more than 1 hour with/without associated sepsis,3)Grade >=3 neutropenic infection,4)Grade 4 thrombocytopenia/Grade 3 thrombocytopenia with clinically significant bleeding,5)Grade 4 anemia 6)Any grade >=3 non-hematology toxicity except:transient Grade 3 flu like symptoms/fever controlled with standard medical management;transient Grade 3 fatigue,localized skin reactions/headache that resolves to Grade <=1;Grade 3 nausea,vomiting/diarrhea resolved to Grade <=1 in ˂72 hours after initiation of adequate medical management;Grade 3 skin toxicity resolved to Grade <=1 in ˂7 days;tumor flare;Single laboratory values that are out of normal range,that have no clinical correlate and resolve to Grade <=1 within 7 days with adequate medical management. | DLT evaluable set included all participants who were randomized in the study and received at least 1 dose of study medication and either experienced DLT during the first cycle, or completed the primary DLT observation period of 4 weeks. | Posted | Count of Participants | Participants | No | Day 1 Cycle 1 up to 4 Weeks |
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| Primary | Objective Response Rate (ORR) as Assessed by Investigator Per Lugano Response Classification Criteria | ORR was defined as percentage of participants with complete response (CR) or partial response (PR), as assessed by investigator per lugano response classification criteria. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [<=] mediastinum), or 3 (uptake less than [<] mediastinum but <=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. PR was defined as >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in sum of products of diameters (SPD) of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. | Full analysis set population included all participants who were randomized in the study. | Posted | Number | 95% Confidence Interval | Percentage of participants | Randomization until date of PD, start of new anticancer therapy, discontinuation from study or death due to any cause, whichever occurred first (maximum up to 36 months) |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Greater Than or Equal to (>=) Grade 3, As Per National Cancer Institute Common Terminology Criteria For Adverse Events (NCI-CTCAE), Version 4.03 | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03,severity was graded as Grade 1:asymptomatic/mild symptoms,clinical/diagnostic observations only, intervention not indicated; Grade 2:moderate, minimal, local/noninvasive intervention indicated,limiting age-appropriate instrumental activities of daily life (ADL); Grade 3:severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4:life-threatening consequence, urgent intervention indicated; Grade 5:death related to AE. TEAE was defined as events which occurred during on-treatment period beginning with first dose of study treatment through minimum (30 days + last dose of study treatment or start of new anti-cancer drug therapy). In this outcome measure participant with any TEAE of Grade 3 or above are reported. | Safety analysis set population included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From first dose of study treatment up to at least 30 days after the last dose of study treatment or initiation of new anti-cancer therapy (up to 36 months) |
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| Secondary | Number of Participants With Laboratory Abnormalities As Per National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.03 | Laboratory parameters included hematological and biochemistry: Hematological parameters included: anemia, haemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cells decreased. Biochemistry parameters included alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholesterol high, creatine kinase(cpk) increased, creatinine increased, gamma glutamyl transferase(ggt) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, lipase increased,serum amylase increased.Test abnormalities were graded by NCI CTCAE version 4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening. Number of participants with abnormalities of any grade were reported. | Safety analysis set population included all participants who received at least 1 dose of study drug. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Count of Participants | Participants | From first dose of study treatment up to at least 30 days after the last dose of study treatment or initiation of new anti-cancer therapy (up to 36 months) |
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| Secondary | Number of Participants With Electrocardiogram (ECG) Abnormalities | ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (>) 30 millisecond (ms) or 60 ms; absolute value >450 ms, >480 ms and >500 ms; 2) heart rate (HR): absolute value <=50 beats per minute (bpm) and decrease from baseline >=20 bpm; absolute value >=120 bpm and increase from baseline >=20 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS interval: absolute value >=120 ms. | Safety analysis set population included all participants who received at least 1 dose of study drug. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Count of Participants | Participants | From first dose of study treatment up to at least 30 days after the last dose of study treatment or initiation of new anti-cancer therapy (up to 36 months) |
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| Secondary | Duration of Response (DOR) as Assessed by Investigator Per Lugano Response Classification Criteria | Investigator assessed DOR: was defined for participants with OR as time from first documentation of OR to time of first documentation of disease progression/death due to any cause, whichever occurred first. CR: 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. PR: >=50% decrease in SPD of up to 6 of largest dominant lymph nodes,no increase in size of other nodes,liver,spleen volume,>=50% decrease in SPD of hepatic splenic nodules,absence of other organ involvement,no new sites of disease. PD: appearance of new lesion more than 1.5 cm in any axis,at least a 50% increase from nadir in SPD/longest diameter of previous lesion/node. Data was censored on date of last adequate tumor assessment in participants with no event,started new anti-cancer therapy/had 2 or more missing assessments. | Participants who were randomized and achieved an objective response. | Posted | Median | 95% Confidence Interval | Months | First response (CR or PR) to date of PD, start of new anti-cancer therapy, discontinuation from the study, censoring date or death due to any cause, whichever occurred first (maximum up to 36 months) |
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| Secondary | Time to Tumor Response (TTR) as Assessed by Investigator Per Lugano Response Classification Criteria | TTR was defined for participants who achieved objective response as time from randomization to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as 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 and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow. PR was defined as >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. | Participants who were randomized and achieved an objective response. | Posted | Median | Full Range | Months | From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to 36 months) |
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| Secondary | Disease Control Rate as Assessed by the Investigator Per Lugano Response Classification Criteria | Disease control rate was defined as percentage of participants with disease control. Disease Control (DC) was defined as the best overall response of CR, PR, or stable disease (SD). CR: score of 1 (no uptake above background), 2 (uptake <= mediastinum), or 3 (uptake less than <mediastinum but <=liver) with or 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. PR: >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. SD: <50% decrease in SDP of up to 6 dominant, measurable nodes and extranodal sites; no criteria for progressive disease met. To qualify as a best overall response of SD, at least one SD assessment must be observed >=6 weeks after start date and before disease progression. | Full analysis set population included all participants who were randomized in the study. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of randomization to the first documentation of PD, study discontinuation, start of new anti-cancer therapy or death due to any cause, whichever occurred first (maximum up to 36 months) |
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| Secondary | Progression-Free Survival (PFS) as Assessed by the Investigator Per Lugano Response Classification Criteria | Investigator assessed PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. PFS data was censored on the date of the last adequate tumor assessment for participants who had no an event (PD or death), for participants who start a new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing or inadequate post-baseline tumor assessment. Participants without an adequate baseline or post-baseline tumor assessment were censored on the date of randomization unless death occurred on or before the time of the second planned tumor assessment in which case the death was considered as an event. | Full analysis set population included all participants who were randomized in the study. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization to progression of disease, study discontinuation, censoring date or death due to any cause, whichever occurred first (up to 36 months) |
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| Secondary | Overall Survival | Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method. | Full analysis set population included all participants who were randomized in the study. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization to discontinuation from the study or death, whichever occurred first (maximum up to 36 months) |
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| Secondary | Concentration Verses Time Summary of Avelumab | Avelumab pharmacokinetic concentration analysis set included all participants who received at least 1 dose of study drug and who had at least 1 post-dose concentration measurement above the lower limit of quantitation for avelumab. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Mean | Standard Deviation | microgram per milliliter (mcg/mL) | 1 hour Post dose Day 2 Cycle 1, 144 hour Post dose Day 8 of Cycle 1, 0 hour Post dose Day 16 of Cycle 1, Day 1 of Cycle 4 and Cycle 6 |
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| Secondary | Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status | ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. | Avelumab immunogenicity analysis set included participants who had at least 1 ADA sample collected for avelumab. | Posted | Count of Participants | Participants | Baseline: 2 hours pre-dose of first dose of avelumab, Post baseline: post first dose up to up to 30 Days after the end of treatment (maximum up to 36 months) |
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| Secondary | Number of Participants With Anti-Drug Antibodies (ADA) Against Rituximab by Never and Ever Positive Status | ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. | Rituximab immunogenicity analysis set included participants who had at least 1 ADA sample collected for rituximab. | Posted | Count of Participants | Participants | From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months) |
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| Secondary | Number of Participants With Anti-Drug Antibodies (ADA) Against Utomilumab by Never and Ever Positive Status | ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. | Utomilumab immunogenicity analysis set included participants who had at least 1 ADA sample collected for utomilumab. | Posted | Count of Participants | Participants | From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months) |
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| Secondary | Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status | nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point. | Data for this outcome measure was not collected since there was no participants with post-baseline ADA ever positive sample for avelumab. | Posted | From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months) |
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| Secondary | Number of Participants With Neutralizing Antibodies (nAb) Against Rituximab by Never and Ever Positive Status | nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point. | Data for this this outcome measure was not collected since there was no participant with rituximab ADA ever positive sample. | Posted | From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months) |
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| Secondary | Number of Participants With Neutralizing Antibodies (nAb) Against Utomilumab by Never and Ever Positive Status | nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point. | Utomilumab immunogenicity analysis set included participants from the safety analysis set who had at least one ADA/nAb sample collected for utomilumab. Here, 'overall number of participants analyzed' signifies number of participants who were ADA positive and whose samples were further analyzed for nAb. | Posted | Count of Participants | Participants | From the date of first study treatment up to 30 Days after the end of treatment (maximum up to 36 months) |
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| Secondary | Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor and Immune Cells as Assessed by Immunohistochemistry (IHC) at Baseline | Percentage of Tumor and Immune Cells as Assessed by Immunohistochemistry at Baseline. | Full analysis set population included all participants who were randomized in the study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | Full Range | Percentage of cells staining positive | Screening (prior to first dose of study treatment) |
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| Secondary | Number of Participants With Minimal Residual Disease Burden (MRD) Positive, Negative and Not Evaluable (NE) Status | Number of participants with MRD positive, negative and not evaluable status were reported in this outcome measure. | Safety analysis set population included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline, Day 1 of Cycle 3, 6, 9, 12 and 18 |
|
Baseline up to follow up (36 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study drug.
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 | Avelumab+Rituximab+Utomilumab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days. | 4 | 8 | 3 | 8 | 8 | 8 |
| EG001 | Avelumab+Azacitidine+Utomilumab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Azacitidine 40 mg/m^2 SC dose was administered on Days 1 to 5 of each treatment cycle until the participant no longer received clinical benefit, along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days. | 8 | 9 | 6 | 9 | 9 | 9 |
| EG002 | Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. | 6 | 11 | 7 | 11 | 11 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.1 | Non-systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Blood calcium | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Blood chloride increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Lipase decreased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Microalbuminuria | Renal and urinary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Primary hypothyroidism | Endocrine disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
|
Data for Phase 3 outcome measures were not collected as study was terminated early and phase 3 was not conducted.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 12, 2018 | Nov 20, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| 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 |
|---|---|
| C000609138 | avelumab |
| C577122 | utomilumab |
| D000069283 | Rituximab |
| D001374 | Azacitidine |
| D000069461 | Bendamustine Hydrochloride |
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| 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 |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003841 | Deoxycytidine |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Race: Other |
|
| OG001 | Avelumab+Azacitidine+Utomilumab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Azacitidine 40 mg/m^2 SC dose was administered on Days 1 to 5 of each treatment cycle until the participant no longer received clinical benefit, along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days. |
| OG002 | Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. |
|
|
| OG001 | Avelumab+Azacitidine+Utomilumab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Azacitidine 40 mg/m^2 SC dose was administered on Days 1 to 5 of each treatment cycle until the participant no longer received clinical benefit, along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days. |
| OG002 | Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. |
|
|
| OG001 | Avelumab+Azacitidine+Utomilumab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Azacitidine 40 mg/m^2 SC dose was administered on Days 1 to 5 of each treatment cycle until the participant no longer received clinical benefit, along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days. |
| OG002 | Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. |
|
|
| OG001 | Avelumab+Azacitidine+Utomilumab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Azacitidine 40 mg/m^2 SC dose was administered on Days 1 to 5 of each treatment cycle until the participant no longer received clinical benefit, along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days. |
| OG002 | Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. |
|
|
| OG001 | Avelumab+Azacitidine+Utomilumab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Azacitidine 40 mg/m^2 SC dose was administered on Days 1 to 5 of each treatment cycle until the participant no longer received clinical benefit, along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days. |
| OG002 | Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. |
|
|
| OG001 | Avelumab+Azacitidine+Utomilumab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Azacitidine 40 mg/m^2 SC dose was administered on Days 1 to 5 of each treatment cycle until the participant no longer received clinical benefit, along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days. |
| OG002 | Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. |
|
|
| OG001 | Avelumab+Azacitidine+Utomilumab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Azacitidine 40 mg/m^2 SC dose was administered on Days 1 to 5 of each treatment cycle until the participant no longer received clinical benefit, along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days. |
| OG002 | Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. |
|
|
| OG001 | Avelumab+Azacitidine+Utomilumab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Azacitidine 40 mg/m^2 SC dose was administered on Days 1 to 5 of each treatment cycle until the participant no longer received clinical benefit, along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days. |
| OG002 | Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. |
|
|
| OG002 | Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. |
|
|
| OG002 | Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. |
|
|
| OG002 | Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. |
|
|
|
|
|
|
| OG002 | Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. |
|
|
Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Azacitidine 40 mg/m^2 SC dose was administered on Days 1 to 5 of each treatment cycle until the participant no longer received clinical benefit, along with fixed dose of 100 mg IV infusion of utomilumab on Day 2 of each treatment cycle in Cycles 1 and 2. If the dose of utomilumab was well tolerated, then it was administered on Day 1 of Cycle 3 and all subsequent cycles until the participant no longer received clinical benefit. The duration of each treatment cycle was 28 days. |
|
|
| OG002 | Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. |
|
|
| OG002 | Avelumab+Bendamustine+Rituximab | Avelumab 10 mg/kg IV infusion was administered every 2 weeks on Day 2 and Day 16 of Cycles 1 and 2, if well tolerated then continued on Day 1 and Day 15 in Cycle 3 and all subsequent cycles, until the participant no longer received clinical benefit. Rituximab 375 mg/m^2 IV infusion was administered on Day 1 of each treatment cycle (maximum of 8 cycles), along with 90 mg/m^2 IV infusion of bendamustine on Day 2 and Day 3 of each treatment cycle in Cycles 1 and 2. If the dose of bendamustine was well tolerated, then it was administered on Day 1 and Day 2 in Cycle 3 and all subsequent cycles for a maximum of 6 cycles. The duration of each treatment cycle was 28 days. |
|
|