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)



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:December 22, 2015
End Date:April 17, 2020

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A Phase IB/II Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus CHOP in Patients With Follicular Lymphoma or Rituximab Plus CHOP in Patients With Diffuse Large B-Cell Lymphoma

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)
We found this trial at
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Irving, Texas 75063
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Aurora, Colorado 80012
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Austin, Texas 78731
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333 East 38th Street
New York, New York 10016
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New York, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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4800 Friendship Ave
Pittsburgh, Pennsylvania 15224
(412) 578-5000
Western Pennsylvania Hospital Featuring 308 private patient beds, West Penn Hospital has served Bloomfield and...
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Springfield, OR
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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