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)

NCT02951156

Last updated date
Study Location
City of Hope
Duarte, California, 91010, United States
Contact
1-800-718-1021

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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.

Key

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).

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Diffuse Large B-Cell LymphomaAvelumab 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)
NCT02951156
  1. Duarte, California
  2. Louisville, Kentucky
  3. Louisville, Kentucky
  4. Louisville, Kentucky
  5. New Orleans, Louisiana
  6. Billerica, Massachusetts
  7. Ann Arbor, Michigan
  8. Rochester, Minnesota
  9. East Setauket, New York
  10. Kogarah, New South Wales
  11. Clayton, Victoria
  12. Heidelberg, Victoria
  13. Heidelberg, Victoria
  14. Gent,
  15. Leuven,
  16. Rozzano, MI
  17. Rozzano, MI
  18. Seoul,
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  20. Lublin, Lubelskie
  21. Krakow, Malopolskie
  22. Krakow,
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  24. Zamosc,
  25. Caceres,
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  27. Málaga,
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Advanced Information
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Large B-Cell Lymphoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2019)
29
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2016)
500
Actual Study Completion Date  ICMJE December 2, 2019
Actual Primary Completion Date December 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

-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.

Key Exclusion Criteria:

  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Italy,   Korea, Republic of,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries Czechia,   Denmark,   France,   Netherlands,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT02951156
Other Study ID Numbers  ICMJE B9991011
2016-002904-15 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description: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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE EMD Serono
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP