A Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination with Atezolizumab plus Polatuzumab Vedotin in Patients with Relapsed or Refractory Follicular Lymphoma and Rituximab in Combination with Atezolizumab plus Polatuzumab Vedotin in Patients with Relapsed or Refractory Diffuse large B-cell Lymphoma
- Conditions
- Follicular Lymphoma (FL) or Diffuse Large B-cell Lymphoma (DLBCL)MedDRA version: 20.0Level: LLTClassification code 10016904Term: Follicle centre lymphoma, follicular grade I, II, III NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-004845-25-PL
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
- Age >=18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- For G + Atezo + Pola treatment group: relapsed or refractory FL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody and for which no other more appropriate treatment option exists as determined by the investigator
- For R + Atezo + Pola treatment group: relapsed or refractory DLBCL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody in patients who are not eligible for second line combination (immuno-)chemotherapy and autologous stem-cell transplantation or who have failed second line combination (immuno-)chemotherapy or experienced disease progression (DP) following autologous stem-cell transplantation
- Histologically documented CD20-positive lymphoma as determined by the local laboratory
- Fluorodeoxyglucose (FDG)-avid lymphoma (i.e., PET-positive lymphoma)
- At least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by computed tomography (CT) scan or magnetic resonance imaging [MRI])
- Availability of a representative tumour specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of FL or DLBCL
- For women of childbearing potential, agreement to remain abstinent or to use single highly effective or combined contraceptive methods that result in a failure rate of <1% per year during the treatment period for >= 5 months after the last dose of atezolizumab, >= 12 months after the last dose of rituximab, >= 12 months after the last dose of polatuzumab vedotin, and >=18 months after the last dose of obinutuzumab
- For men, agreement to remain abstinent or to use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of obinutuzumab, rituximab and atezolizumab, and 5 months after the last dose of polatuzumab vedotin and to refrain from donating sperm during this same period
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 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 43
- Grade 3b follicular lymphoma
- History of transformation of indolent disease to DLBCL
- Known CD20-negative status at relapse or progression
- Central nervous system (CNS) lymphoma or leptomeningeal infiltration
- Prior allogeneic stem-cell transplantation (SCT)
- Completion of autologous SCT within 100 days prior to Day 1 of Cycle 1
- Prior standard or investigational anti-cancer therapy
- Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade <= 2 (as per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], v4.0) prior to Day 1 of Cycle 1
- Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1
- History of solid organ transplantation and severe allergic or anaphylactic reaction to humanized, chimeric, or murine monoclonal antibodies
- Known hypersensitivity or allergy to murine products and biopharmaceuticals or any component of the atezolizumab, obinutuzumab, rituximab or polatuzumab vedotin formulations
- Known history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis or evidence of active pneumonitis on screening chest CT scan
- Active bacterial, viral, fungal, or other infection
- Positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening
- History of HIV positive status
- History of progressive multifocal leukoencephalopathy
- Vaccination with a live virus vaccine or live attenuated vaccine within 28 days prior to Day 1 of Cycle 1
- History of other malignancy
- History of autoimmune disease
- Grade > 1 peripheral neuropathy present at screening
- Any significant, uncontrolled concomitant disease
- Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1
- Inadequate haematologic and liver function (unless due to underlying lymphoma) defined as aspartate aminotransferase (AST) > upper limit of normal (ULN) or serum total bilirubin > ULN for patients enrolled in dose escalation phase and for the patients enrolled in the expansion phase the defined criteria is AST or alanine transaminase (ALT) > 2.5 × ULN and serum total bilirubin > 1.5 × ULN (or > 3 × ULN for patient with Gilbert syndrome
- Abnormal laboratory values (unless due to underlying lymphoma)
- Pregnant or lactating, or intending to become pregnant during the study
- Life expectancy < 3 months
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method