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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02631577
First received: December 14, 2015
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Lymphoma, Follicular
Drug: Atezolizumab (MPDL3280A) [TECENTRIQ]
Drug: Lenalidomide
Drug: Obinutuzumab
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A PHASE Ib/II STUDY EVALUATING THE SAFETY AND EFFICACY OF ATEZOLIZUMAB IN COMBINATION WITH OBINUTUZUMAB PLUS LENALIDOMIDE IN PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Incidence of dose-limiting toxicities (DLTs) during cycle 2 of study treatment [ Time Frame: Day 1- Day 28 of second cycle ]
  • Percentage of Participants Achieving CR at EOI, as Determined by the Independent Review Committee (IRC) Using Lugano Criteria [ Time Frame: 6 months ]
  • Percentage of Participants With Adverse Events and Serious Adverse Events [ Time Frame: 30 months ]

Secondary Outcome Measures:
  • Percentage of Participants Achieving CR at EOI, as Determined by the Investigator Using Lugano Criteria [ Time Frame: 6 months ]
  • Percentage of Participants Achieving CR at EOI, as Determined by the IRC and Investigator Using Modified Cheson Criteria [ Time Frame: 6 months ]
  • Percentage of Participants With Objective Response (CR or PR) at EOI [ Time Frame: 6 months ]
  • Percentage of Participants With Objective Response (CR or PR) During the Study [ Time Frame: 30 months ]

Estimated Enrollment: 46
Study Start Date: December 2015
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atezolizumab-G-lena
Dose escalation phase: Participants with relapsed or refractory FL will receive obinutuzumab (G) and lenalidomide (lena) during Cycle 1 (28-day cycle) and atezolizumab (MPDL3280A), obinutuzumab, and lenalidomide during Cycles 2-6, during induction treatment, followed by atezolizumab (MPDL3280A; monthly) and obinutuzumab (every other month [q2m]) for 24 months as well as lenalidomide for 12 months, during maintenance treatment. Expansion phase: Participants with previously untreated FL will receive same treatment regimen as described for dose escalation phase.
Drug: Atezolizumab (MPDL3280A) [TECENTRIQ]
Atezolizumab will be administered at a flat dose of 840 mg on Days 1 and 15 of Cycles 2 to 6, given in 28-day cycles as induction treatment and 840 mg on Days 1 and 2 of each month, given as maintenance treatment.
Drug: Lenalidomide
Lenalidomide will be administered orally once daily on Days 1 to 21 of Cycles 1 to 6 (28-day cycles) during induction treatment and on Days 1 to 21 of each month during maintenance treatment. Lenalidomide will be administered at a dose of 15 or 20 mg (dose may be de-escalated to 10 mg) during induction treatment and at 10 mg during maintenance treatment. During the expansion phase, lenalidomide will be administered at the RP2D during induction treatment and at 10 mg during maintenance treatment.
Drug: Obinutuzumab
Obinutuzumab will be administered by intravenous infusion at an absolute (flat) dose of 1000 mg on Days 1, 8, and 15 of the first cycle and on Day 1 of each subsequent cycle during induction treatment, and on Day 1 of every other month (i.e., every 2 months) during maintenance treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02631577

Contacts
Contact: Reference Study ID Number: BO29562 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States, 35294-0017
United States, Florida
Recruiting
Miami, Florida, United States, 33136
United States, Georgia
Not yet recruiting
Atlanta, Georgia, United States, 30322
United States, Kentucky
Recruiting
Louisville, Kentucky, United States, 40207
United States, New York
Recruiting
New York, New York, United States, 10065
United States, North Carolina
Recruiting
Charlotte, North Carolina, United States, 28204
France
Recruiting
Creteil, France, 94010
Not yet recruiting
Dijon, France, 21034
Recruiting
Le Mans, France, 72015
Recruiting
Le Mans, France, 72037
Recruiting
Lille, France, 59037
Recruiting
Montpellier, France, 34295
Recruiting
Nantes, France, 44093
Recruiting
Pierre Benite, France, 69495
Not yet recruiting
Rennes, France, 35033
Recruiting
Rouen, France, 76038
Not yet recruiting
Toulouse, France, 31059
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02631577     History of Changes
Other Study ID Numbers: BO29562
2015-002467-42 ( EudraCT Number )
Study First Received: December 14, 2015
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lenalidomide
Thalidomide
Antibodies, Monoclonal
Obinutuzumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on March 27, 2017