Lymphoma, FollicularPhase 1/2NCT02631577
A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma
A Phase 1/2 study testing Atezolizumab (MPDL3280A) [TECENTRIQ], Lenalidomide and Obinutuzumab in people with Lymphoma, Follicular, run by Hoffmann-La Roche at 16 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Follicular
- What is being tested?
- Atezolizumab (MPDL3280A) [TECENTRIQ], Lenalidomide and Obinutuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 31 Dec 2015to 7 Oct 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
France11 sites
Chu Toulouse
Bron, 69500
Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny
Créteil, 94010
Hopital du Bocage
Dijon, 21034
Centre Jean Bernard
Le Mans, 72015
Centre Hospitalier Le Mans
Le Mans, 72037
CHRU de Lille - Hopital Claude Huriez
Lille, 59037
CHU Montpellier - Saint ELOI
Montpellier, 34295
CHU - Hôtel Dieu hematolgie clinique
Nantes, 44093
Centre Hospitalier Lyon Sud; Hematolgie
Pierre-Bénite, 69495
CHU de Rennes - Hopital de Pontchaillo
Rennes, 35033
Centre Henri Becquerel
Rouen, 76038
United States5 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Levine Cancer Institute
Charlotte, North Carolina, 28204
Norton Medical Plaza II
Louisville, Kentucky, 40207
University Miami
Miami, Florida, 33136
Memorial Sloan-Kettering Cancer Center; Hematology/Oncology
New York, New York, 10065
About this study
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
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
- Being tested
- Atezolizumab (MPDL3280A) [TECENTRIQ], Lenalidomide, Obinutuzumab
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
LenalidomideDrug
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.
ObinutuzumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab-G-lena 15mg | Experimental | Participants were administered obinutuzumab, Atezolizumab, and 15 mg of Lenalidomide. Receives: Drug: Atezolizumab (MPDL3280A) [TECENTRIQ]; Drug: Lenalidomide; Drug: Obinutuzumab |
| Atezolizumab-G-lena 20mg | Experimental | Participants were administered obinutuzumab, Atezolizumab, and 20 mg of Lenalidomide. Receives: Drug: Atezolizumab (MPDL3280A) [TECENTRIQ]; Drug: Lenalidomide; Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
CR was evaluated through use of PET-CT scans, using the Modified Lugano 2014 criteria. Response was determined by the Investigator.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to approximately 59 months
Number of Participants With Dose-limiting Toxicities (DLTs) During Cycle 2 of Study Treatment
Does limiting toxicity (DLT) is defined as any one of the following events occurring during Cycle 2 of treatment and assessed by the investigator as related to study treatment: - Adverse event of any grade that leads to a delay of more than 14 days at the start of the next treatment cycle; - Hematologic adverse events (neutropenia, thrombocytopenia); - Non-hematologic adverse event, except IRRs, diarrhea, nausea or vomiting
Measured: Day 1 - Day 28 of second cycle
Serum Concentration of Obinutuzumab (mcg/mL)
The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year
Measured: Baseline up to approximately 59 months
Serum Concentration of Atezolizumab (mcg/mL)
The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year
Measured: Baseline up to approximately 59 months
Serum Concentration of Lenalidomide (ng/mL)
The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; HR = Hour
Measured: Baseline up to approximately 59 months
Number of Participants Positive for Human Anti-human Antibodies (HAHA) to Obinutuzumab
The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year. All baseline and post-baseline samples from participants were negative for HAHAs to obinutuzumab and the results are shown below.
Measured: Baseline up to approximately 59 months
Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab
The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year. All baseline and post-baseline samples were negative for ATAs to atezolizumab and the results are shown below.
Measured: Baseline up to approximately 59 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study start31 Dec 2015
- Primary completion23 Oct 2018
- Study completion7 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lymphoma, FollicularStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631577
- Sponsor's protocol ID
- BO29562
- Other IDs
- 2015-002467-42, 2015
- Status last verified
- Apr 2022
- First submitted
- 14 Dec 2015
- Last updated
- 13 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02631577
- Acronym / sponsor ID
- BO29562
- Conditions
- Lymphoma, Follicular
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2015 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 7 Oct 2020 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Posted 30 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab-G-lena 15mg | Experimental | Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], Drug: Lenalidomide, Drug: ObinutuzumabParticipants were administered obinutuzumab, Atezolizumab, and 15 mg of Lenalidomide. |
| Atezolizumab-G-lena 20mg | Experimental | Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], Drug: Lenalidomide, Drug: ObinutuzumabParticipants were administered obinutuzumab, Atezolizumab, and 20 mg of Lenalidomide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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])
Key exclusion criteria (24 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Atezolizumab-G-lena 15mg, Atezolizumab-G-lena 20mg |
| LenalidomideLenalidomide 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 | Atezolizumab-G-lena 15mg, Atezolizumab-G-lena 20mg |
| ObinutuzumabObinutuzumab 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. | Drug | Atezolizumab-G-lena 15mg, Atezolizumab-G-lena 20mg |
Primary outcome
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
Time frame: 6 months (up to clinical cut-off date (CCOD) of 23 October 2018)
Complete response (CR) was evaluated through use of PET-CT scans, using the Modified Lugano 2014 criteria. Response was determined by the IRC.
12 secondary outcomes
Percentage of Participants Achieving CR at EOI, as Determined by the Investigator Using Modified Lugano 2014 Criteria
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
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
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
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
Time frame: 30 months
Percentage of Participants With Adverse Events and Serious Adverse Events
Time frame: Baseline up to approximately 59 months
Number of Participants With Dose-limiting Toxicities (DLTs) During Cycle 2 of Study Treatment
Time frame: Day 1 - Day 28 of second cycle
Serum Concentration of Obinutuzumab (mcg/mL)
Time frame: Baseline up to approximately 59 months
Serum Concentration of Atezolizumab (mcg/mL)
Time frame: Baseline up to approximately 59 months
Serum Concentration of Lenalidomide (ng/mL)
Time frame: Baseline up to approximately 59 months
Number of Participants Positive for Human Anti-human Antibodies (HAHA) to Obinutuzumab
Time frame: Baseline up to approximately 59 months
Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab
Time frame: Baseline up to approximately 59 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Atezolizumab (MPDL3280A) [TECENTRIQ], Lenalidomide and Obinutuzumab in people with Lymphoma, Follicular, run by Hoffmann-La Roche at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months (up to clinical cut-off date (CCOD) of 23 October 2018)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.