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

NCT02631577 | Completed Phase 1 Results

• 2 other identifiers: BO295622015-002467-42
• Study Type: interventional
• Target: 38
• Locations: 2 countries
• Sites: 16

Brief Summary

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.

Conditions

Lymphoma, Follicular

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (12)

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

  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

  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

  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

  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

  30 months

Study Arms (2)

Atezolizumab-G-lena 15mg

EXPERIMENTAL

Participants were administered obinutuzumab, Atezolizumab, and 15 mg of Lenalidomide.

Drug: Atezolizumab (MPDL3280A) [TECENTRIQ]; Drug: Lenalidomide; Drug: Obinutuzumab

Atezolizumab-G-lena 20mg

EXPERIMENTAL

Participants were administered obinutuzumab, Atezolizumab, and 20 mg of Lenalidomide.

Drug: Atezolizumab (MPDL3280A) [TECENTRIQ]; Drug: Lenalidomide; Drug: Obinutuzumab

Interventions

Atezolizumab (MPDL3280A) [TECENTRIQ] DRUG

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.

Atezolizumab-G-lena 15mg; Atezolizumab-G-lena 20mg

Lenalidomide DRUG

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.

Atezolizumab-G-lena 15mg; Atezolizumab-G-lena 20mg

Obinutuzumab DRUG

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.

Atezolizumab-G-lena 15mg; Atezolizumab-G-lena 20mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (16)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University Miami

Miami, Florida, 33136, United States

Location

Norton Medical Plaza II

Louisville, Kentucky, 40207, United States

Location

Memorial Sloan-Kettering Cancer Center; Hematology/Oncology

New York, New York, 10065, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Chu Toulouse

Bron, 69500, France

Location

Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny

Créteil, 94010, France

Location

Hopital du Bocage

Dijon, 21034, France

Location

Centre Jean Bernard

Le Mans, 72015, France

Location

Centre Hospitalier Le Mans

Le Mans, 72037, France

Location

CHRU de Lille - Hopital Claude Huriez

Lille, 59037, France

Location

CHU Montpellier - Saint ELOI

Montpellier, 34295, France

Location

CHU - Hôtel Dieu hematolgie clinique

Nantes, 44093, France

Location

Centre Hospitalier Lyon Sud; Hematolgie

Pierre-Bénite, 69495, France

Location

CHU de Rennes - Hopital de Pontchaillo

Rennes, 35033, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

atezolizumab; Lenalidomide; obinutuzumab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Enrollment for this study was stopped early as the Sponsor chose not to claim superiority over existing therapies.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 16, 2015
• Study Start: December 31, 2015
• Primary Completion: October 23, 2018
• Study Completion: October 7, 2020
• Last Updated: April 13, 2022
• Results First Posted: December 30, 2019

Record last verified: 2022-04

Locations

FR (11); US (5)