A Study of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus (+) Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Follicular Lymphoma (FL) or Rituximab + CHOP in Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Completed · Phase 1/Phase 2
Conditions studied: Diffuse Large B-Cell Lymphoma, Lymphoma Follicular
In brief
This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment consisting of atezolizumab in combination with either obinutuzumab + bendamustine (Atezo-G-benda) or obinutuzumab + CHOP (Atezo-G-CHOP) in participants with FL and atezolizumab + rituximab + chemotherapy (Atezo-R-CHOP) in participants with DLBCL, followed by post-induction treatment consisting of either atezolizumab plus obinutuzumab (Atezo-G) in participants with FL who achieve a complete response (CR) or partial response (PR) at end of induction (EOI) or atezolizumab alone in participants with DLBCL who achieve a CR at EOI.
Key facts
- Study ID
- NCT02596971
- Run by
- Hoffmann-La Roche
- People needed
- 91
- Starts
- 2015-12-22
- Expected to finish
- 2020-05-08
- Last updated by the study team
- 2021-05-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- For participants enrolled in the safety run-in phase: lymphoma classified as either relapsed or refractory FL after treatment with at least one prior chemoimmunotherapy regimen or previously untreated Grade 1, 2, or 3a FL that requires treatment
- For participants enrolled in the expansion phase: lymphoma classified as either previously untreated Grade 1, 2, or 3a FL that requires treatment or previously untreated advanced DLBCL
- Histologically documented cluster of differentiation 20 (CD20) positive lymphoma
- Fluorodeoxyglucose-avid lymphoma
- At least one bi-dimensionally measurable lesion (greater than [>] 1.5 centimeters in its largest dimension by CT scan or magnetic resonance imaging)
- 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 (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than [<] 1 percent [%] per year during the treatment period and for at least 18 months after the last dose of study treatment for participants in the Atezo-G-benda and Atezo-G-CHOP treatment groups or for at least 12 months after the last dose of study treatment for participants in the Atezo-R-CHOP treatment group
- For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm
You may not qualify if…
- Histological evidence of transformation of FL into high-grade B-cell non-Hodgkin's lymphoma (NHL)
- Central nervous system lymphoma or leptomeningeal infiltration
- For participants with DLBCL: preplanned consolidative radiotherapy
- Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1
- For participants with relapsed or refractory FL: prior allogeneic or autologous stem cell transplantation, anthracycline therapy, treatment with fludarabine or alemtuzumab within 12 months prior to Day 1 of Cycle 1, treatment with a monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate within 4 weeks prior to Day 1 of Cycle 1, radiotherapy, chemotherapy, hormonal therapy, or targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
- History of solid organ transplantation
- History of severe allergic or anaphylactic reaction or known sensitivity to humanized or murine monoclonal antibodies
- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab, obinutuzumab, rituximab, or bendamustine formulation, including mannitol
- Positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening
- History of progressive multifocal leukoencephalopathy
- Vaccination with a live virus vaccine within 28 days prior to Day 1 of Cycle 1
- History of other malignancy, autoimmune disease, or any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results
- Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1, or anticipation of a major surgical procedure during the course of the study
- For participants who will be receiving CHOP: left ventricular ejection fraction (LVEF) <50% by multiple-gated acquisition (MUGA) scan or echocardiogram
- Inadequate hematologic, renal, and liver function (unless due to underlying lymphoma)
Where it is running
- Rocky Mountain Cancer Center - Aurora — Aurora, Colorado, United States
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- University Miami — Miami, Florida, United States
- New York Uni Medical Center — New York, New York, United States
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
- Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute — Springfield, Oregon, United States
- Western Pennsylvania Hospital — Pittsburgh, Pennsylvania, United States
- Texas Oncology — Austin, Texas, United States
- Texas Oncology-Tyler — Irving, Texas, United States
- Concord Repatriation General Hospital; Haematology — Sydney, New South Wales, Australia
- Calvary Mater Newcastle — Waratah, New South Wales, Australia
- The Queen Elizabeth Hospital; Haematology/Oncology — Woodville South, South Australia, Australia
- Monash Medical Centre — Clayton, Victoria, Australia
- Austin Hospital — Heidelberg, Victoria, Australia
- Azienda Ospedaliera S. Orsola-Malpighi — Bologna, Emilia-Romagna, Italy
- Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori — Meldola, Emilia-Romagna, Italy
- Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia — Ravenna, Emilia-Romagna, Italy
- Ospedale Infermi di Rimini — Rimini, Emilia-Romagna, Italy
- AOU Città della Salute e della Scienza di Torino - Presidio Le Molinette — Torino, Lazio, Italy
- Asst Papa Giovanni XXIII — Bergamo, Lombardy, Italy
- Azienda Ospedaliera Univ — Florence, Tuscany, Italy
Full record on ClinicalTrials.gov
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