Lymphoma, Non-HodgkinPhase 1NCT03369964
A Study of Atezolizumab in Combination With an Immunotherapy Agent Investigated With or Without Anti-Cd20 Therapy in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
A Phase 1 study testing Atezolizumab, Emactuzumab and Obinutuzumab in people with Lymphoma, Non-Hodgkin, run by Hoffmann-La Roche at 2 sites in United States.
Trial summary
This study will investigate the safety, pharmacology, and activity of atezolizumab in combination with immunotherapy agents with or without an anti-CD20 agent (i.e., obinutuzumab) in patients with relapsed or refractory (R/R) follicular lymphoma (FL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- Atezolizumab, Emactuzumab and Obinutuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Mar 2018to 31 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Life expectancy ≥ 12 weeks
- At least two bi-dimensionally measurable nodal lesions ≥ 1.5 centimeters (cm) in its longest diameter by imaging
- Adequate hematologic and end-organ function
- For women of childbearing potential: agreement to remain abstinent
- For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm
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- Consent to collection of a pre-treatment tumor sample, on-treatment biopsy, and, if applicable, a tumor tissue sample at the time of progressive disease (PD)
- Inclusion Criteria Specific to Obinutuzumab-Containing Cohorts
- Patients receiving therapeutic anticoagulation should be switched to low molecular weight heparin (LMWH) before the first cycle of obinutuzumab
Who cannot join
- Any approved systemic anti-cancer therapy (including chemotherapy) or hormonal therapy within 3 weeks prior to initiation of study treatment
- Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to enrollment
- Known central nervous system (CNS) lymphoma, leptomeningeal lymphoma
- Grade 3b FL, small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), or other lymphoma subtypes except as stated in the inclusion criteria
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
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- Uncontrolled hypercalcemia
- History of other malignancy within 5 years prior to screening with the exception of malignancies with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
- Known hypersensitivity to any of the study drugs
- History of sensitivity to mannitol
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
- Pregnant and lactating women
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation, emactuzumab formulation, or obinutuzumab formulation
- History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis (RA), inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
- Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest computed tomography (CT) scan at screening
- Serum albumin < 2.5 g/dL
- Positive test for HIV (human immunodeficiency virus)
- All patients will have a tuberculin (purified protein derivative [PPD]) skin test or interferon-gamma release assay (IGRA) done locally prior to the inclusion into the study. Patients with active tuberculosis (TB) will be excluded from the study.
- History of chronic hepatitis B virus (HBV) infection or positive test results for active or chronic HBV infection defined by hepatitis B surface antigen (HBsAg)
- Patients with active or chronic hepatitis C virus (HCV)
- Active TB
- Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
- Significant cardiovascular disease, such as cardiac disease, myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina
- Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1 or anticipation of a major surgical procedure during the course of the study
- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies
- Treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF)) within 2 weeks prior to Cycle 1, Day 1
- The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed
- Exclusion Criteria Specific to Obinutuzumab-Containing Cohorts:
- Hypersensitivity to obinutuzumab
- Prior treatment with obinutuzumab
- Fludarabine or Campath within 12 months prior to study entry
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (e.g., patients in whom dosing with obinutuzumab would be contraindicated for safety reasons)
- Received therapeutic oral or IV antibiotics within 4 weeks prior to Cycle 1, Day 1 (except for tumor fever)
- Patients with history of confirmed progressive multifocal leukoencephalopathy
- Regular treatment with corticosteroids within the 4 weeks prior to the start of Cycle 1, unless administered for indications other than NHL at a dose equivalent to < 30 mg/day prednisone/prednisolone
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Tennessee Oncology
Nashville, Tennessee, 37203
About this study
Official title: A Phase Ib Study of The Safety and Pharmacology of Atezolizumab in Combination With an Immunotherapy Agent Investigated With or Without Anti-Cd20 Therapy in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
This study will investigate the safety, pharmacology, and activity of atezolizumab in combination with immunotherapy agents with or without an anti-CD20 agent (i.e., obinutuzumab) in patients with relapsed or refractory (R/R) follicular lymphoma (FL). The first immunotherapy molecule investigated will be emactuzumab (Arm A) in two combinations.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- Atezolizumab, Emactuzumab, Obinutuzumab
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
In Cohort A1, Atezolizumab will be administered, 1200 mg IV, every 3 weeks starting on Cycle 2; Day 1 of a 21 day cycle
In Cohort A2, Atezolizumab will be administered, 1200 mg IV, starting on Cycle 2; Day 1 of a 21 day cycle
In Cohort A2 , In Cycle 2-8, Atezolizumab will be administered, 1200 mg IV on day 1 of each 21 day cycle
In Cohort A2, Atezolizumab will be administered, 1200 mg IV starting on Cycle 9; Day 1 of each 21 day cycle
EmactuzumabDrug
In Cohort A1, Emactuzumab will be administered 1000 mg IV, every 3 weeks, starting on Cycle 1; Day 1 of a 21 day cycle.
In Cohort A2, Emactuzumab will be administered 1000 mg IV, starting on Cycle 1 Day 1 of a 21 day cycle.
In Cohort A2, in cycle 2-8, Emactuzumab will be administered 1000 mg IV, on day 1 of each 21 day cycle.
In Cohort A2, Emactuzumab will be administered 1000 mg IV starting on Cycle 9; on Day 1 of each 21 day cycle
ObinutuzumabDrug
In Cohort A2, Obinutuzumab will be administered 1000 mg IV starting on Cycle 1; Day 1 of a 21 day cycle
In Cohort A2, Obinutuzumab will be administered again on days 8 and 15 (Cycle 1) of a 21 day cycle
In Cohort A2, in cycle 2-8, Obinutuzumab will be administered 1000 mg IV on day 1 of each 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab + Emactuzumab | Experimental | Participants will receive Atezolizumab and Emactuzumab on Day 1 of each 21- day cycle Receives: Drug: Atezolizumab; Drug: Emactuzumab |
| Atezolizumab + Emactuzumab + Obinutuzumab | Active comparator | Participants will receive Atezolizumab, Emactuzumab, and Obinutuzumab on Day 1 of each- 21 day cycle (starting in cycle 2)
(Atezolizumab starting in cycle 2); and Obinutuzumab on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2-8. Receives: Drug: Atezolizumab; Drug: Emactuzumab; Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events
Measured: Baseline to end of study (approximately 48 months)
Secondary outcomes (7)
Serum concentration of Atezolizumab at specified timepoints
Measured: Cohort A1 and A3 Cycle 2-4, Day 1 pre and post infusion; Cycle 6, 8, Day 1 pre-infusion; Every 8 cycles after cycle 8, Day 1 pre-infusion. Cohort A2 and A4 Cycle 2 and 4, Day 1 pre- and post infusion, Cycle 3,6, and 8, Day 1 pre-infusion.
Serum concentration of Obinutuzumab at specified timepoints
Measured: Cohort A2 and A4 Cycle 1,6,8, and every 8 cycles post cycle 8, Day 1 prior to infusion; Cycle 1, Day 2, post infusion; Cycle 1, Day 8 and 15, pre and post infusion; Cycle 2,3, and 4, Day 1, pre and post infusion. (Cycle = 21 days)
Serum concentration of Emactuzumab at specified timepoints
Measured: Cohort A1 and A3 Cycle 1-4, Day 1 pre and post infusion; Cycle 6, 8 and every 8 cycles post cycle 8, pre-infusion. Cycle 1-4 Day 1 pre and post infusion; Cycle 1, Day 15 pre-infusion. Cycle 6, 8 and every 8 cycles post cycle 8, Day 1 pre-infusion.
Objective Response
Measured: Baseline to end of study (approximately 48 months)
Duration of Objective Response (DOR)
Measured: Baseline to end of study (approximately 48 months)
Progression Free Survival (PFS)
Measured: Baseline to end of study (approximately 48 months)
Overall Survival (OS)
Measured: Baseline to end of study (approximately 48 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start14 Mar 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Aug 2019 (estimated)
Why it stopped: Business decision: no safety or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT03369964
- Sponsor's protocol ID
- GO40150
- Other IDs
- 2017-002587-41, 2017
- Status last verified
- Apr 2018
- First submitted
- 7 Dec 2017
- Last updated
- 5 Apr 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of The Safety and Pharmacology of Atezolizumab in Combination With an Immunotherapy Agent Investigated With or Without Anti-Cd20 Therapy in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT03369964
- Acronym / sponsor ID
- GO40150
- Conditions
- Lymphoma, Non-Hodgkin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision: no safety or efficacy concerns.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
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 investigate the safety, pharmacology, and activity of atezolizumab in combination with immunotherapy agents with or without an anti-CD20 agent (i.e., obinutuzumab) in patients with relapsed or refractory (R/R) follicular lymphoma (FL). The first immunotherapy molecule investigated will be emactuzumab (Arm A) in two combinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab + Emactuzumab | Experimental | Drug: Atezolizumab, Drug: EmactuzumabParticipants will receive Atezolizumab and Emactuzumab on Day 1 of each 21- day cycle |
| Atezolizumab + Emactuzumab + Obinutuzumab | Active comparator | Drug: Atezolizumab, Drug: Emactuzumab, Drug: ObinutuzumabParticipants will receive Atezolizumab, Emactuzumab, and Obinutuzumab on Day 1 of each- 21 day cycle (starting in cycle 2) (Atezolizumab starting in cycle 2); and Obinutuzumab on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2-8. |
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
- Life expectancy ≥ 12 weeks
- At least two bi-dimensionally measurable nodal lesions ≥ 1.5 centimeters (cm) in its longest diameter by imaging
- Adequate hematologic and end-organ function
- For women of childbearing potential: agreement to remain abstinent
Key exclusion criteria (38 listed)
- Any approved systemic anti-cancer therapy (including chemotherapy) or hormonal therapy within 3 weeks prior to initiation of study treatment
- Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to enrollment
- Known central nervous system (CNS) lymphoma, leptomeningeal lymphoma
- Grade 3b FL, small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), or other lymphoma subtypes except as stated in the inclusion criteria
- Uncontrolled tumor-related pain
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 |
|---|---|---|
| AtezolizumabIn Cohort A1, Atezolizumab will be administered, 1200 mg IV, every 3 weeks starting on Cycle 2; Day 1 of a 21 day cycle In Cohort A2, Atezolizumab will be administered, 1200 mg IV, starting on Cycle 2; Day 1 of a 21 day cycle In Cohort A2 , In Cycle 2-8, Atezolizumab will be administered, 1200 mg IV on day 1 of each 21 day cycle In Cohort A2, Atezolizumab will be administered, 1200 mg IV starting on Cycle 9; Day 1 of each 21 day cycle | Drug | Atezolizumab + Emactuzumab, Atezolizumab + Emactuzumab + Obinutuzumab |
| EmactuzumabIn Cohort A1, Emactuzumab will be administered 1000 mg IV, every 3 weeks, starting on Cycle 1; Day 1 of a 21 day cycle. In Cohort A2, Emactuzumab will be administered 1000 mg IV, starting on Cycle 1 Day 1 of a 21 day cycle. In Cohort A2, in cycle 2-8, Emactuzumab will be administered 1000 mg IV, on day 1 of each 21 day cycle. In Cohort A2, Emactuzumab will be administered 1000 mg IV starting on Cycle 9; on Day 1 of each 21 day cycle | Drug | Atezolizumab + Emactuzumab, Atezolizumab + Emactuzumab + Obinutuzumab |
| ObinutuzumabIn Cohort A2, Obinutuzumab will be administered 1000 mg IV starting on Cycle 1; Day 1 of a 21 day cycle In Cohort A2, Obinutuzumab will be administered again on days 8 and 15 (Cycle 1) of a 21 day cycle In Cohort A2, in cycle 2-8, Obinutuzumab will be administered 1000 mg IV on day 1 of each 21 day cycle | Drug | Atezolizumab + Emactuzumab + Obinutuzumab |
Primary outcome
Percentage of Participants with Adverse Events
Time frame: Baseline to end of study (approximately 48 months)
7 secondary outcomes
Serum concentration of Atezolizumab at specified timepoints
Time frame: Cohort A1 and A3 Cycle 2-4, Day 1 pre and post infusion; Cycle 6, 8, Day 1 pre-infusion; Every 8 cycles after cycle 8, Day 1 pre-infusion. Cohort A2 and A4 Cycle 2 and 4, Day 1 pre- and post infusion, Cycle 3,6, and 8, Day 1 pre-infusion.
Serum concentration of Obinutuzumab at specified timepoints
Time frame: Cohort A2 and A4 Cycle 1,6,8, and every 8 cycles post cycle 8, Day 1 prior to infusion; Cycle 1, Day 2, post infusion; Cycle 1, Day 8 and 15, pre and post infusion; Cycle 2,3, and 4, Day 1, pre and post infusion. (Cycle = 21 days)
Serum concentration of Emactuzumab at specified timepoints
Time frame: Cohort A1 and A3 Cycle 1-4, Day 1 pre and post infusion; Cycle 6, 8 and every 8 cycles post cycle 8, pre-infusion. Cycle 1-4 Day 1 pre and post infusion; Cycle 1, Day 15 pre-infusion. Cycle 6, 8 and every 8 cycles post cycle 8, Day 1 pre-infusion.
Objective Response
Time frame: Baseline to end of study (approximately 48 months)
Duration of Objective Response (DOR)
Time frame: Baseline to end of study (approximately 48 months)
Progression Free Survival (PFS)
Time frame: Baseline to end of study (approximately 48 months)
Overall Survival (OS)
Time frame: Baseline to end of study (approximately 48 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atezolizumab, Emactuzumab and Obinutuzumab in people with Lymphoma, Non-Hodgkin, run by Hoffmann-La Roche at 2 sites in United States.
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 38 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: withdrawn, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 with Adverse Events (time frame: Baseline to end of study (approximately 48 months)). 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 5 Apr 2018.