Spots Global Cancer Trial Database for 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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Trial Identification
Brief Title: 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: 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 ID: NCT02951156
Conditions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
Farmacia Studi Clinici, Rozzano, MI, Italy
Istituto Clinico Humanitas, Rozzano, MI, Italy
Samsung Medical Center Clinical Trial Pharmacy, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli, Lublin, Lubelskie, Poland
Malopolskie Centrum Medyczne S.C., Krakow, Malopolskie, 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., Zamosc, , Poland
Hospital San Pedro de Alcantara, Caceres, , Spain
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
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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