RSH_BO29561

A PHASE Ib/II STUDY EVALUATING THE SAFETY AND EFFICACY OF OBINUTUZUMAB IN COMBINATION WITH ATEZOLIZUMAB PLUS POLATUZUMAB VEDOTIN IN PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA OR DIFFUSE LARGE B CELL LYMPHOMA

Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) A21 Status of 0, 1, or 2 For participants enrolled in the dose-escalation phase: 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 participants enrolled in the expansion phase: lymphoma classified as either relapsed or refractory FL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody and for which not other more appropriate treatment option exists as determined by the investigator OR classified as 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 chemotherapy and autologous stem-cell transplantation or who have failed second line combination chemotherapy or experienced disease progression following autologous stem-cell transplantation Histologically documented CD20-positive lymphoma and fluorodeoxyglucose (FDG)-avid lymphoma (that is positron emission tomography [PET]-positive lymphoma) with at least one bi-dimensionally measurable lesion Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of FL or DLBCL For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or to use contraceptive methods that result in a failure rate of = 18 months after the last dose of obinutuzumab For men: agreement to remain abstinent or to use contraceptive measures that result in a failure rate of 1 neuropathy Major surgical procedure other than for diagnosis within 28 days prior to D1C1 Inadequate hematologic function, renal function, and liver function Pregnant or lactating women Life expectancy less than (
Phase I
NCT02729896
Cancer, All Other
Hematologic
Ying Zhuo, M.D.
Roche Holding AG (Hoffman-LaRoche)
Megan Greenough
  • Kadlec Research