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)

Part of paid clinical trials in Duarte, California.

Sponsor
Pfizer
Study ID
NCT02951156
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Avelumab — BIOLOGICAL
    Investigational fully human anti-PD-L1 monoclonal antibody
  • Utomilumab — BIOLOGICAL
    Investigational, fully human IgG2 CD 137/4-1BB agonist
  • Rituximab — BIOLOGICAL
    CD20-directed cytolytic antibody
  • Azacitidine — OTHER
    Antimetabolite antineoplastic agent and demethylation agent.
  • Bendamustine — DRUG
    Alkylating drug
  • Gemcitabine — DRUG
    Nucleoside analogue
  • Oxaliplatin — DRUG
    Platinum-based drug

Study Details

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).

Key Dates

Start date
Dec 16, 2016
Status verified
Nov 2020
Primary completion
Dec 2, 2019
Completion
Dec 2, 2019

Study Design

Enrollment
29 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b Arm A
    avelumab/utomilumab/rituximab
  • Experimental: Phase 1b Arm B
    avelumab/utomilumab/azacitidine
  • Experimental: Phase 1b Arm C
    avelumab/rituximab/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
  • Active Comparator: Phase 3 Arm E
    Investigator's Choice of either rituximab/bendamustine or rituximab/gemcitabine/oxaliplatin

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLT) [ Time Frame: Day 1 Cycle 1 up to 4 Weeks ]

Locations (9)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Norton Cancer InstituteLouisvilleKentucky40207-
Norton Diagnostic Center - DupontLouisvilleKentucky40207-
Norton Women's and Children's HospitalLouisvilleKentucky40207-
Tulane Medical CenterNew OrleansLouisiana70112-
Parexel InternationalBillericaMassachusetts01821-
University of Michigan Health SystemAnn ArborMichigan48109-
Mayo ClinicRochesterMinnesota55905-
North Shore Hematology Oncology AssociatesEast SetauketNew York11733-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CANorton Cancer Institute· Louisville, KYNorton Diagnostic Center - Dupont· Louisville, KYNorton Women's and Children's Hospital· Louisville, KYTulane Medical Center· New Orleans, LAParexel International· Billerica, MA

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