Avelumab In Combination Regimens That Include An Immune Agonist, Epigenetic Modulator, CD20 Antagonist and/or Conventional Chemotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)
NCT ID: NCT02951156
Last Updated: 2020-12-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
29 participants
INTERVENTIONAL
2016-12-16
2019-12-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1b Arm A
avelumab/utomilumab/rituximab
Avelumab
Investigational fully human anti-PD-L1 monoclonal antibody
Utomilumab
Investigational, fully human IgG2 CD 137/4-1BB agonist
Rituximab
CD20-directed cytolytic antibody
Phase 1b Arm B
avelumab/utomilumab/azacitidine
Avelumab
Investigational fully human anti-PD-L1 monoclonal antibody
Utomilumab
Investigational, fully human IgG2 CD 137/4-1BB agonist
Azacitidine
Antimetabolite antineoplastic agent and demethylation agent.
Phase 1b Arm C
avelumab/rituximab/bendamustine
Avelumab
Investigational fully human anti-PD-L1 monoclonal antibody
Rituximab
CD20-directed cytolytic antibody
Bendamustine
Alkylating drug
Phase 3 Arm D (selected from Phase 1b)
Selected regimen from Phase 1b component which may be i) avelumab/utomilumab/rituximab OR ii) avelumab/rituximab/azacitidine OR iii) avelumab/rituximab/bendamustine
Avelumab
Investigational fully human anti-PD-L1 monoclonal antibody
Utomilumab
Investigational, fully human IgG2 CD 137/4-1BB agonist
Rituximab
CD20-directed cytolytic antibody
Azacitidine
Antimetabolite antineoplastic agent and demethylation agent.
Bendamustine
Alkylating drug
Phase 3 Arm E
Investigator's Choice of either rituximab/bendamustine or rituximab/gemcitabine/oxaliplatin
Rituximab
CD20-directed cytolytic antibody
Bendamustine
Alkylating drug
Gemcitabine
Nucleoside analogue
Oxaliplatin
Platinum-based drug
Interventions
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Avelumab
Investigational fully human anti-PD-L1 monoclonal antibody
Utomilumab
Investigational, fully human IgG2 CD 137/4-1BB agonist
Rituximab
CD20-directed cytolytic antibody
Azacitidine
Antimetabolite antineoplastic agent and demethylation agent.
Bendamustine
Alkylating drug
Gemcitabine
Nucleoside analogue
Oxaliplatin
Platinum-based drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diffuse large B-cell lymphoma (DLBCL), Not Otherwise Specified (NOS): Germinal center B-cell type (GCB), Activated B-cell type (ABC)
* High-grade B-cell lymphoma (HGBCL) NOS
* HGBCL with MYC and BCL2 and/or BCL6 rearrangements
* T-cell histocyte-rich large B-cell lymphoma
* EBV+ DLBCL, NOS
* HHV8+ DLBCL, NOS
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.
* Baseline measurable disease with at least 1 bi dimensional lesion with longest diameter (LDi) \>1.5cm on CT scan which is FDG avid on PET scan.
* A biopsy (archived or Screening/recent) will be collected at Screening.
* At least 18years of age (or ≥20 years in Japan).
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
Exclusion Criteria
* Prior organ transplantation including prior allogeneic SCT.
* Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab, tremelimumab or any other antibody, or drug specifically targeting T cell co stimulatory or immune checkpoint pathways).
18 Years
ALL
No
Sponsors
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EMD Serono
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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City of Hope
Duarte, California, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Norton Diagnostic Center - Dupont
Louisville, Kentucky, United States
Norton Women's and Children's Hospital
Louisville, Kentucky, United States
Tulane Medical Center
New Orleans, Louisiana, United States
Parexel International
Billerica, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
North Shore Hematology Oncology Associates
East Setauket, New York, United States
St. George Hospital
Kogarah, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Cancer Clinical Trials Centre, Austin Health, Level 4
Heidelberg, Victoria, Australia
Genesis Care
Heidelberg, Victoria, Australia
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Farmacia Studi Clinici
Rozzano, MI, Italy
Istituto Clinico Humanitas
Rozzano, MI, Italy
Malopolskie Centrum Medyczne S.C.
Krakow, Lesser Poland Voivodeship, Poland
Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli
Lublin, Lublin Voivodeship, Poland
Nzoz McD Voxel Osrodek Pet-Tk-Nmr
Krakow, , Poland
Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli Oddzial Hematologiczny
Lublin, , Poland
NU-MED Centrum Diagnostyki i Terapii Onkologicznej Zamosc Sp. z o.o.
Zamość, , Poland
Samsung Medical Center Clinical Trial Pharmacy
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital San Pedro de Alcantara
Cáceres, , Spain
Centro de Investigación Medicina Especializada Sanitaria (CIMES)
Málaga, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
The Christie NHS Foundation Trust
Manchester, , United Kingdom
The Christie Pathology Partnership
Manchester, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2016-002904-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B9991011
Identifier Type: -
Identifier Source: org_study_id