A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma

Hoffmann-La Roche38 enrolled

Overview

This study will evaluate the safety, efficacy, pharmacokinetics and immunogenicity of induction treatment consisting of atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma (FL), followed by maintenance treatment with atezolizumab plus obinutzumab plus lenalidomide in patients who achieve a complete response (CR), a partial response (PR), or stable disease at end of induction.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma, Follicular

Interventions

Atezolizumab (MPDL3280A) [TECENTRIQ]

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * 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 * Histologically documented CD20-positive lymphoma as determined by the local laboratory * Fluorodeoxyglucose-avid lymphoma (i.e., PET-positive lymphoma) * At least one bi-dimensionally measurable lesion (\>1.5 cm in its largest dimension by CT scan or magnetic resonance imaging \[MRI\]) * Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of FL * Agreement to comply with all local requirements of the lenalidomide risk minimization plan * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of \<1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period (including periods of treatment interruption), and for at least 18 months after the last dose of study treatment * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm for at least 3 months after the last dose of study treatment Exclusion Criteria: * Grade 3b follicular lymphoma * History of transformation of indolent disease to diffuse large B-cell lymphoma (DLBCL) * Known CD20-negative status at relapse or progression * Central nervous system lymphoma or leptomeningeal infiltration * Prior allogeneic stem-cell transplantation (SCT) * Completion of autologous SCT within 100 days prior to Day (D) 1 of Cycle (C) 1 * Prior standard or investigational anti-cancer therapy as specified in protocol * History of resistance to lenalidomide or response duration of \<1 year * Treatment with systemic immunosuppressive medications * History of solid organ transplantation * Clinically significant toxicity from prior therapy that has not resolved to Grade \<=2 (according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\], v4.0) prior to Day 1 of Cycle 1 * History of erythema multiforme, Grade \>= 3 rash, or blistering following prior treatment with immunomodulatory derivatives such as thalidomide and lenalidomide * 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 * Known history of HIV positive status * History of progressive multifocal leukoencephalopathy * History of autoimmune disease * Contraindication to treatment for TE prophylaxis * Grade \<= 2 neuropathy * History of other malignancy that could affect compliance with the protocol or interpretation of results * Evidence of any significant, uncontrolled concomitant disease * Inadequate hematologic function (unless due to underlying lymphoma) * Abnormal laboratory values (unless due to underlying lymphoma) * Pregnant or lactating or intending to become pregnant during the study

Locations (16)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University Miami

Miami, Florida, United States

Norton Medical Plaza II

Louisville, Kentucky, United States

Memorial Sloan-Kettering Cancer Center; Hematology/Oncology

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Chu Toulouse

Bron, France

Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny

Créteil, France

Hopital du Bocage

Dijon, France

Centre Jean Bernard

Le Mans, France

Centre Hospitalier Le Mans

Le Mans, France

...and 6 more locations

Outcomes

Primary Outcomes

Percentage of Participants Achieving Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria

Complete response (CR) was evaluated through use of PET-CT scans, using the Modified Lugano 2014 criteria. Response was determined by the IRC.

Time frame: 6 months (up to clinical cut-off date (CCOD) of 23 October 2018)

Secondary Outcomes

Percentage of Participants Achieving CR at EOI, as Determined by the Investigator Using Modified Lugano 2014 Criteria

CR was evaluated through use of PET-CT scans, using the Modified Lugano 2014 criteria. Response was determined by the Investigator.

Time frame: 6 months (up to CCOD of 23 October 2018)

Percentage of Participants Achieving CR at EOI, as Determined by the IRC and Investigator Using Lugano 2014 Criteria

CR was evaluated through use of CT scans, using the Lugano 2014 criteria. Response was determined by the IRC and by the Investigator.

Time frame: 6 months (up to CCOD of 23 October 2018)

Percentage of Participants With Objective Response (CR or PR) at EOI as Determined by the IRC and Investigator on the Basis of PET-CT Scans

Objective response was evaluated through use of PET-CT scans, using the Lugano 2014 or modified Lugano 2014 criteria. Response was determined by the IRC and by the Investigator.

Time frame: 6 months (up to CCOD of 23 October 2018)

Percentage of Participants With Objective Response (CR or PR) at EOI as Determined by the IRC and Investigator on the Basis of CT Scans Alone

Objective response was evaluated through use of CT scans alone, using the Lugano 2014. Response was determined by the IRC and by the Investigator.

Time frame: 6 months (up to CCOD of 23 October 2018)

Percentage of Participants With Best Response (CR or PR) During the Study as Determined by the Investigator on the Basis of CT Scans Alone

Best Response was evaluated through use of CT scans alone, using the Lugano 2014. Response was determined by the Investigator.

Time frame: 30 months

Percentage of Participants With Adverse Events and Serious Adverse Events

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.