Phase 2
N=38
A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma
Lymphoma, Follicular
Bottom Line
View on ClinicalTrials.gov: NCT02631577 ↗Enrolled (actual)
38
Serious AEs
47.4%
Results posted
Dec 2019
Primary outcome: Primary: 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 — 71.9 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Atezolizumab (MPDL3280A) [TECENTRIQ] (Drug); Lenalidomide (Drug); Obinutuzumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
71.9 | — |
| SECONDARY Percentage of Participants Achieving CR at EOI, as Determined by the Investigator Using Modified Lugano 2014 Criteria |
75 | — |
| SECONDARY Percentage of Participants Achieving CR at EOI, as Determined by the IRC and Investigator Using Lugano 2014 Criteria |
31.3; 50 | — |
| SECONDARY 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 |
81.3; 84.4; 78.1; 84.4 | — |
| SECONDARY 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 |
81.3; 87.5 | — |
| SECONDARY Percentage of Participants With Best Response (CR or PR) During the Study as Determined by the Investigator on the Basis of CT Scans Alone |
87.5; 68.8; 18.8 | — |
| SECONDARY Percentage of Participants With Adverse Events and Serious Adverse Events |
4; 34; 2; 16 | — |
| SECONDARY Number of Participants With Dose-limiting Toxicities (DLTs) During Cycle 2 of Study Treatment |
0; 0 | — |
| SECONDARY Serum Concentration of Obinutuzumab (mcg/mL) |
0.634; 364; 375; 288; 392; 606 | — |
| SECONDARY Serum Concentration of Atezolizumab (mcg/mL) |
0.184; 345; 279; 73.8; 90.0; 128 | — |
| SECONDARY Serum Concentration of Lenalidomide (ng/mL) |
12.6; 13.0; 254; 294; 3.57; 15.0 | — |
| SECONDARY Number of Participants Positive for Human Anti-human Antibodies (HAHA) to Obinutuzumab |
4; 34; 3; 27; 0; 15 | — |
| SECONDARY Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab |
4; 31; 2; 32; 3; 29 | — |
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.
Eligibility 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 = 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
Data sourced from ClinicalTrials.gov (NCT02631577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.