Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Trial acronym
Javelin DLBCL
Clinical summary
Summary
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. The site at Monash Medical Centre, Haematology Research Unit is recruiting to Arm C ONLY.
Conditions
This trial is treating people with Diffuse Large B-Cell Lymphoma (DLBCL)
Eligibility
Inclusion
-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
- 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).
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Pfizer
Scientific 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
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