Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive … (NCT03038672) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas
United States54 participantsStarted 2018-12-21
Plain-language summary
This phase II trial studies how well nivolumab with or without varlilumab works in treating patients with aggressive B-cell lymphomas that have come back (recurrent) or do not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as varlilumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have a histopathologically confirmed diagnosis of an aggressive B-cell non-Hodgkin lymphoma that is recurrent or refractory to standard therapy
* For the purpose of this study, aggressive B-cell NHL will be deemed any lymphoma belonging to one of the following groups according to the 2016 revision of the World Health Organization (WHO) classification of lymphoid neoplasms
* For the purposes of stratification, diagnoses are grouped into 2 categories:
* Category A
* Burkitt lymphoma
* Burkitt-like lymphoma with 11q aberration
* High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
* High-grade B-cell lymphoma, not otherwise specified (NOS)
* Category B
* Diffuse large B-cell lymphoma (DLBCL), NOS
* Diffuse large B-cell lymphoma (DLBCL), NOS; germinal center B-cell type
* Diffuse large B-cell lymphoma (DLBCL), NOS; activated B-cell type
* Large B-cell lymphoma with IRF4 rearrangement
* T-cell/histiocyte-rich large B-cell lymphoma
* Primary DLBCL of the central nervous system (CNS)
* Primary cutaneous DLBCL, leg type
* Epstein-Barr virus (EBV)+ DLBCL, NOS
* EBV+ mucocutaneous ulcer
* DLBCL associated with chronic inflammation
* Lymphomatoid granulomatosis
* Primary mediastinal (thymic) large B-cell lymphoma
* Intravascular large B-cell lymphoma
* ALK+ large B-cell lymphoma
* Plasmablastic lymphoma
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.