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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)

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
City of Hope Investigational Drug Services
Duarte, California, 91010 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diffuse Large B-Cell Lymphoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

-Any of the following as defined by the WHO, 2016 lymphoid neoplasm classifications and
histologically confirmed:

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Active central nervous system (CNS) lymphoma.

- 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).

NCT02951156
Pfizer
Recruiting
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)

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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)
Phase 1b/Phase 3 Multicenter Study Of Avelumab (msb0010718c) 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 (Dlbcl) Javelin Dlbcl
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diffuse Large B-Cell Lymphoma
  • Biological: Avelumab
    Investigational fully human anti-PD-L1 monoclonal antibody
    Other Name: MSB0010718C
  • Biological: Utomilumab
    Investigational, fully human IgG2 CD 137/4-1BB agonist
    Other Name: PF-05082566
  • Biological: Rituximab
    CD20-directed cytolytic antibody
    Other Name: Rituxan
  • Other: Azacitidine
    Antimetabolite antineoplastic agent and demethylation agent.
    Other Name: Vidaza
  • Drug: Bendamustine
    Alkylating drug
    Other Name: Treanda
  • Drug: Gemcitabine
    Nucleoside analogue
    Other Name: Gemzar
  • Drug: Oxaliplatin
    Platinum-based drug
    Other Name: Eloxatin
  • Experimental: Phase 1b Arm A
    avelumab/utomilumab/rituximab
    Interventions:
    • Biological: Avelumab
    • Biological: Utomilumab
    • Biological: Rituximab
  • Experimental: Phase 1b Arm B
    avelumab/utomilumab/azacitidine
    Interventions:
    • Biological: Avelumab
    • Biological: Utomilumab
    • Other: Azacitidine
  • Experimental: Phase 1b Arm C
    avelumab/rituximab/bendamustine
    Interventions:
    • Biological: Avelumab
    • Biological: Rituximab
    • Drug: Bendamustine
  • Experimental: 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
    Interventions:
    • Biological: Avelumab
    • Biological: Utomilumab
    • Biological: Rituximab
    • Other: Azacitidine
    • Drug: Bendamustine
  • Active Comparator: Phase 3 Arm E
    Investigator's Choice of either rituximab/bendamustine or rituximab/gemcitabine/oxaliplatin
    Interventions:
    • Biological: Rituximab
    • Drug: Bendamustine
    • Drug: Gemcitabine
    • Drug: Oxaliplatin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
304
May 29, 2021
March 20, 2020   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Relapsed or refractory DLBCL 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 >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.

Key Exclusion Criteria:

  • Transformed lymphoma or Burkitt's Lymphoma.
  • Active/symptomatic central nervous system (CNS) lymphoma based on clinical evaluation.
  • 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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Australia,   Belgium,   Czechia,   Denmark,   Italy,   Poland,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT02951156
B9991011
2016-002904-15 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
EMD Serono
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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