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 DLBC

Pfizer Inc, 235 East 42nd Street, New York, NY 100170 个研究点目标入组 304 人开始时间: 2017年3月28日最近更新: 2019年2月28日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Pfizer Inc, 235 East 42nd Street, New York, NY 10017
入组人数: 304

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

入选标准

•1. Histologically confirmed DLBCL.
•2. Documentation that the disease is relapsed or refractory 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.
•3. Patients previously treated with bendamustine must have experienced a response duration =6 months.
•4. Documentation of baseline measurable disease with at least 1 bi-dimensional lesion >1.5 cm on CT scan which is fluorodeoxyglucose (FDG) avid on PET scan.
•5. A biopsy (archived or Screening/recent) will be collected at Screening.
•6. Estimated life expectancy =3 months.
•7. At least 18 years of age (or =20 years in Japan).
•8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
•9. All adverse events must have resolved to NCI CTCAE v.4.03 Grade =1 (with the exception of alopecia and other Grade =2 AEs not considered medically relevant in the judgment of the Investigator).
•10. Patients must have an adequate bone marrow function, including: a. Absolute neutrophil count (ANC) =1.5 x 10(9)/L; b. Platelet count =100 x 10(9)/L; c. Hemoglobin =8 g/dL.
•11. Patients must have adequate liver function, including: a. Total bilirubin level =1.5 × upper limit of normal (ULN); b. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 x ULN.
•12. Patients must have an adequate renal function as evidenced by a creatinine clearance =40 mL/min as calculated using the Cockcroft-Gault equation.
•13. Serum or urine pregnancy test (for females of childbearing potential) must be negative.
•14. Female patients of non-childbearing potential must meet at least 1 of the following
•criteria: Achieved postmenopausal status, defined as follows: cessation of regular menses
•for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state; Have undergone a documented hysterectomy and/or bilateral oophorectomy; Have medically confirmed ovarian failure. All other female patients (including female patients with tubal ligations) are considered to be of childbearing potential.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 152
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 152

排除标准

•1. Transformed lymphoma or Burkitt’s Lymphoma.
•2. Active/symptomatic central nervous system (CNS) lymphoma based on clinical evaluation.
•3. Prior organ transplantation including prior allogeneic SCT.
•4. 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).
•5. Use of any standard or experimental anti-cancer therapy within 2 weeks prior to randomization, including cytoreductive therapy and radiotherapy, immunotherapy, or cytokine therapy (except for erythropoietin).
•6. Use of any non-drug anti-cancer therapy including chimeric antigen receptor (CAR) T-Cell (CAR-T-Cell) therapy.
•7. Major surgery within 28 days prior to first dose of study treatment.
•8. Diagnosis of any other malignancy =3 years prior to first dose of study treatment, with the exception of: (i) adequately treated basal cell or squamous cell skin cancer, (ii) carcinoma in situ of the breast or cervix, or (iii) low-grade (Gleason =6) prostate cancer on surveillance without any plans for treatment intervention (eg, surgery, radiation, or castration).
•9. Known history of testing positive for human immunodeficiency virus ( HIV) or known acquired immunodeficiency syndrome.
•10. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen, positive HBV core antibody or HCV ribonucleic acid (RNA) if anti-HCV antibody screening test positive).
•11. Active infection requiring systemic therapy.
•12. Vaccination within 4 weeks prior to randomization and while on trial is prohibited except for administration of inactivated vaccines.
•13. Peripheral neuropathy with functional impairment (for the Phase 3 component only due to oxaliplatin).
•14. Current use of immunosuppressive medication, EXCEPT for the following: a.) intranasal, inhaled, topical steroids, or local steroid injection (eg, intra-articular injection); b.) Systemic corticosteroids at physiologic doses =10 mg/day of prednisone or equivalent; c.) Steroids as premedication for hypersensitivity reactions
•(eg, CT scan premedication).
•15. Active autoimmune disease that might deteriorate when receiving an
•immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypoor
•hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
•16. Known anaphylaxis or severe hypersensitivity to rituximab or other monoclonal
•antibodies, mannitol, or any of the compounds used in this study or to compounds
•with a similar chemical or biological composition.72
•17. Clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke/transient ischemic attack [TIA]/symptomatic pulmonary embolism (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (=New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication, other severe acute or chronic medical (including coliti

研究者

发起方

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

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