Lymphoma, B-CellPhase 2NivoMNCT03569696
Improving the Outcome of High-risk Aggressive B-cell Lymphoma Patients With Nivolumab Maintenance Therapy
A Phase 2 study testing nivolumab in people with Lymphoma, B-Cell, run by Meirav Kedmi MD at 1 site in Israel.
Trial summary
This trial is designed as a unicenter, single arm phase II trial. The aim of the trial is to test whether prognosis of high-risk Aggressive B cell Lymphoma (ABCL) patients who are in complete remission (CR) post immunochemotherapy can be improved by 2year nivolumab maintenance therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B-Cell
- What is being tested?
- nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Oct 2018to Sep 2023
- Phase
- Phase 2
- 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
- Adult patients age ≥18.
- Histologically confirmed DLBCL, primary mediastinal B cell lymphoma or any other aggressive B-cell lymphoma as defined by the World Health Organization (WHO) 2016 criteria 4, with IPI of 3 or more post completion R- anthracycline containing regimen for at least 6 cycles and in complete remission according to the Lugano Criteria 45 per PETCT.
- Hematology laboratory values must be within the following limits:
- Absolute neutrophil count (ANC) ≥ 1000/mm3 independent of growth factor support
- Platelets ≥100,000/mm3 independent of transfusion support.
- Biochemical values within the following limits:
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- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 x ULN unless the increase is due to Gilbert's syndrome or of non- hepatic origin
- Serum creatinine ≤ 2 x ULN or estimated Glomerular Filtration Rate (Cockroft-Gault)
- 40 mL/min/1.73m2
- Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug.
- Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [Beta-hCG]) or urine pregnancy test at screening. Women who are pregnant or breastfeeding are ineligible for this study.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Sign (or their legally acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.
Who cannot join
- Patients not in CR, as defined by the Lugano Criteria, after completion of first line R- anthracycline based therapy.
- Patients previously treated with any line of therapy for relapsed/refractory disease.
- Major surgery within 4 weeks of starting the first nivolumab infusion.
- Previous treatment with nivolumab or any other PD-1 or PD-L1/2 inhibitors.
- Prior allogeneic stem cell transplantation.
- Known central nervous system lymphoma.
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- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
- Clinically significant pulmonary disease.
- Vaccinated with live, attenuated vaccines within 4 weeks of enrolment.
- Known history of human immunodeficiency virus (HIV).
- Active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics. Hepatitis B core antigen (HBC) positive as well as HBs positive, HBcore positive HBs negative patients will not be eligible.
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety.
- Patients with an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
- There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
- Diagnosed or treated for a malignancy other than DLBCL, except:
- Malignancy treated with curative intent and with no active disease present for 3 years before enrolment
- Adequately treated non-melanoma skin cancer or lentigo malignant without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba medical organization
Ramat Gan
Meirav Kedmi, MD, 972-3-530-2127, Meirav.kedmi@sheba.health.gov.il
Aliza Ackerstein, Msc, 972-3-5308402, aliza.ackerstein@sheba.health.gov.il
About this study
Official title: Improving the Outcome of High-risk Aggressive B-cell Lymphoma Patients With Nivolumab Maintenance Therapy. The NivoM Trial
This trial is designed as a unicenter, single arm phase II trial. The aim of the trial is to test whether prognosis of high-risk Aggressive B cell Lymphoma (ABCL) patients who are in complete remission (CR) post immunochemotherapy can be improved by 2year nivolumab maintenance therapy. Participants will be recruited from Chaim Sheba Medical Center as well as from other medical centers in Israel through the Israeli lymphoma group. Therapy will be treated in Chaim Sheba Medical Center.
Read the detailed description
The rationale for prolonged nivolumab therapy in high-risk ABCL patients in CR following 1st line standard therapy is based on the hypothesis that the stimulation of immune system by Programmed cell death protein 1 (PD1) blockade will also facilitate the eradication of minimal residual disease (MRD), that is not apparent by positron emission tomography (PET) imaging, and eventually will prevent relapse and improve survival. The Study will include adult patients, age ≥18, with high risk (IPI≥3) ABCL, in CR according to PETCT, as defined by the Lugano Criteria, following first-line rituximab (R) and anthracycline-containing regimen.
- Conditions
- Lymphoma, B-Cell
- Being tested
- nivolumab
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nivolumabBiological
The treatment phase will begin 10 ± 2 weeks from completion of R- anthracycline based therapy. Cycle 1 day 1 will occur within 72 hours from enrolment. Study treatment will be continued until nivolumab discontinuation due to disease progression, unacceptable toxicity or completion of 2 years or 30 doses of therapy. Study drug nivolumab will be administered intravenously every 2 weeks as described in the investigator brochure (IB) in a dose of 240mg over 30 minutes 46 for 8 cycles and then 480mg every 4 weeks for two years (cycle 9-30)to a maximum of 30 doses whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab | Experimental | Nivolumab will be administered intravenously every 2 weeks in a dose of 240mg over 30 minutes for 8 cycles and then 480mg every 4 weeks for two years (cycle 9-30)to a maximum of 30 doses whichever comes first. Receives: Biological: nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease progression
To evaluate the proportion of high-risk ABCL patients with no evidence of disease progression
Measured: 3 years post diagnosis of aggressive B cell lymphoma.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start8 Oct 2018
- Primary completionJul 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment All the participating patients will receive 240mg nivolumab every 2 weeks for 8 doses for 4 months, and later 480 mg every 4 weeks for 2 years (cycle 9-30) for a maximum of 30 doses, starting 10±2 weeks after the last cycle of immunochemotherapy.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meirav Kedmi MD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Meirav Kedmi MD, Sheba Medical Center
- Investigators
- Meirav Kedmi, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569696
- Sponsor's protocol ID
- SHEBA-18-4728-MK-CTIL
- Acronym
- NivoM
- Status last verified
- Apr 2019
- First submitted
- 13 Jun 2018
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Outcome of High-risk Aggressive B-cell Lymphoma Patients With Nivolumab Maintenance Therapy. The NivoM Trial
- ClinicalTrials.gov ID
- NCT03569696
- Acronym / sponsor ID
- NivoM / SHEBA-18-4728-MK-CTIL
- Conditions
- Lymphoma, B-Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meirav Kedmi MDOther government
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 26 Jun 2018 (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 trial is designed as a unicenter, single arm phase II trial. The aim of the trial is to test whether prognosis of high-risk Aggressive B cell Lymphoma (ABCL) patients who are in complete remission (CR) post immunochemotherapy can be improved by 2year nivolumab maintenance therapy. Participants will be recruited from Chaim Sheba Medical Center as well as from other medical centers in Israel through the Israeli lymphoma group. Therapy will be treated in Chaim Sheba Medical Center.
Detailed description
The rationale for prolonged nivolumab therapy in high-risk ABCL patients in CR following 1st line standard therapy is based on the hypothesis that the stimulation of immune system by Programmed cell death protein 1 (PD1) blockade will also facilitate the eradication of minimal residual disease (MRD), that is not apparent by positron emission tomography (PET) imaging, and eventually will prevent relapse and improve survival. The Study will include adult patients, age ≥18, with high risk (IPI≥3) ABCL, in CR according to PETCT, as defined by the Lugano Criteria, following first-line rituximab (R) and anthracycline-containing regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment All the participating patients will receive 240mg nivolumab every 2 weeks for 8 doses for 4 months, and later 480 mg every 4 weeks for 2 years (cycle 9-30) for a maximum of 30 doses, starting 10±2 weeks after the last cycle of immunochemotherapy.
| Arm | Type | Receives |
|---|---|---|
| Nivolumab | Experimental | Biological: nivolumabNivolumab will be administered intravenously every 2 weeks in a dose of 240mg over 30 minutes for 8 cycles and then 480mg every 4 weeks for two years (cycle 9-30)to a maximum of 30 doses whichever comes first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adult patients age ≥18.
- Histologically confirmed DLBCL, primary mediastinal B cell lymphoma or any other aggressive B-cell lymphoma as defined by the World Health Organization (WHO) 2016 criteria 4, with IPI of 3 or more post completion R- anthracycline containing regimen for at least 6 cycles and in complete remission according to the Lugano Criteria 45 per PETCT.
- Hematology laboratory values must be within the following limits:
- Biochemical values within the following limits:
- Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug.
Key exclusion criteria (18 listed)
- Patients not in CR, as defined by the Lugano Criteria, after completion of first line R- anthracycline based therapy.
- Patients previously treated with any line of therapy for relapsed/refractory disease.
- Major surgery within 4 weeks of starting the first nivolumab infusion.
- Previous treatment with nivolumab or any other PD-1 or PD-L1/2 inhibitors.
- Prior allogeneic stem cell transplantation.
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 |
|---|---|---|
| nivolumabThe treatment phase will begin 10 ± 2 weeks from completion of R- anthracycline based therapy. Cycle 1 day 1 will occur within 72 hours from enrolment. Study treatment will be continued until nivolumab discontinuation due to disease progression, unacceptable toxicity or completion of 2 years or 30 doses of therapy. Study drug nivolumab will be administered intravenously every 2 weeks as described in the investigator brochure (IB) in a dose of 240mg over 30 minutes 46 for 8 cycles and then 480mg every 4 weeks for two years (cycle 9-30)to a maximum of 30 doses whichever comes first. | Biological | Nivolumab |
Primary outcome
disease progression
Time frame: 3 years post diagnosis of aggressive B cell lymphoma.
To evaluate the proportion of high-risk ABCL patients with no evidence of disease progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Meirav Kedmi, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nivolumab in people with Lymphoma, B-Cell, run by Meirav Kedmi MD at 1 site in Israel.
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 14 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aliza Ackerstein, Msc (97235308402, Aliza.Ackerstein@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease progression (time frame: 3 years post diagnosis of aggressive B cell lymphoma.). 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 23 Apr 2019.