Study on Nivolumab With or Without Varlilumab for Treating Aggressive B-cell Lymphomas That Have Returned or Are Resistant to Treatment
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03038672
This clinical trial is exploring whether the combination of nivolumab and varlilumab, or nivolumab alone, can help treat aggressive B-cell lymphomas that have come back or are not responding to treatment. These medications are types of immunotherapy that may help the immune system fight cancer.
Patient Parameters
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Program Overview
This study is testing how well the drugs nivolumab and varlilumab work in treating aggressive B-cell lymphomas that have returned or are resistant to treatment. These drugs are a form of immunotherapy, which means they help the body's immune system attack cancer cells and may stop the cancer from growing and spreading.
Description
The main goal of this study is to see how effective the combination of varlilumab and nivolumab is compared to nivolumab alone in treating aggressive B-cell non-Hodgkin lymphomas (NHL). Researchers will also look at how safe and tolerable the treatment is, how long the response lasts, and how it affects survival rates.
Participants will be randomly assigned to one of two groups:
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Group I: Participants receive nivolumab through an IV every two weeks for four months, then every four weeks for up to two years, unless the disease progresses or side effects become too severe. If the disease progresses, participants may switch to Group II.
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Group II: Participants receive varlilumab through an IV every four weeks for up to two years, along with nivolumab every two weeks for four months, then every four weeks for up to two years, unless the disease progresses or side effects become too severe.
After finishing the treatment, participants will be monitored for 100 days.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of aggressive B-cell non-Hodgkin lymphoma that has returned or is resistant to standard treatments.
- Must have measurable disease, meaning at least one tumor that can be measured by scans.
- Must have tried at least two standard treatments without success, or be unable or unwilling to try other standard treatments.
- Must have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
- Must have a life expectancy of more than 12 weeks.
- Must meet specific blood count and organ function requirements.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
- Must be able to understand and sign a consent form.
Exclusion Criteria
- Have received chemotherapy, targeted therapy, or radiotherapy within four weeks before starting the study.
- Have received immunotherapy within four weeks before starting the study.
- Have not recovered from side effects of previous treatments.
- Are participating in another clinical trial.
- Have had prior treatment with certain immune therapies.
- Have had a stem cell transplant within 12 weeks before starting the study.
- Have active disease in the central nervous system.
- Have a history of severe allergic reactions to similar drugs.
- Have uncontrolled illnesses or infections.
- Are pregnant or breastfeeding.
- Have certain autoimmune diseases or conditions requiring high doses of steroids.
- Have other active cancers requiring treatment within the last three years.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Hospital in Arizona | 85054 | Phoenix | Arizona |
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| Mayo Clinic in Florida | 32224-9980 | Jacksonville | Florida |
| Moffitt Cancer Center-International Plaza | 33607 | Tampa | Florida |
| Moffitt Cancer Center - McKinley Campus | 33612 | Tampa | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Northside Hospital | 30342 | Atlanta | Georgia |
| Northwestern University | 60611 | Chicago | Illinois |
| University of Chicago Comprehensive Cancer Center | 60637 | Chicago | Illinois |
| University of Kansas Clinical Research Center | 66205 | Fairway | Kansas |
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