Can a weekly drug combo outsmart resistant lymphoma?
NCT ID NCT01703949
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 pilot study tests whether giving brentuximab vedotin weekly, alone or with nivolumab, can help people with CD30+ lymphoma whose cancer stopped responding to the standard every-3-week dosing. The study enrolls 28 adults with relapsed or refractory Hodgkin or non-Hodgkin lymphoma. The goal is to see if the new schedule can shrink tumors in at least 20% (with brentuximab alone) or 40% (with the combination) of patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- brentuximab vedotin (a drug that targets cancer cells) and nivolumab (an immunotherapy that helps the immune system attack cancer)
- What this could lead to
- If successful, this could offer a new treatment option for people with CD30+ lymphoma whose cancer no longer responds to standard brentuximab vedotin dosing.
- What could go wrong
- This is a small, early-phase pilot study with only 28 participants. The response rate targets are modest (20-40%), and the results may not apply to all patients. Side effects from the drugs are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
28 people
The number who actually took part.
- Started
-
Mar 2013
- Expected to finish
-
Jun 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Relapsed or refractory CD30+ lymphoma that has either achieved \< PR to brentuximab vedotin (minimum of 2 cycles), progressed while receiving brentuximab vedotin, or progressed within 6 months of the last dose of brentuximab vedotin * Documented expression of CD30 on tumor cells * Absolute neutrophil count (ANC) \> 1,000/uL * Platelets \> 50,000/uL * Serum creatinine \< 1.5 mg/dL OR creatinine clearance \> 60 mL/min * Bilirubin \< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 x ULN * Measurable disease by computed tomography (CT) or similar (e.g. magnetic resonance imaging \[MRI\]) criteria (\> 1.5 cm). (Patients with cutaneous lymphoma only require measurable disease by Olsen Criteria) * Age \>= 18 yrs at the time of the first dose of study drug * Resolution of all non-hematologic brentuximab vedotin-related and nivolumab-related adverse events (AEs) to \< Grade 2 * All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines * Patients must be anticipated to complete at least 2 cycles of chemotherapy on study * Expected survival if untreated of \> 90 days Exclusion Criteria: * Prior transplant within 100 days * Radioimmunotherapy within 12 weeks * Known human immunodeficiency virus (HIV) or hepatitis B positivity or prior progressive multifocal leukoencephalopathy (PML) * Active infection or other medical condition which would preclude treatment in the opinion of the principal investigator; this would include a corrected diffusing capacity of the lungs for carbon monoxide (DLCO) of \< 60% predicted or symptomatic interstitial lung disease * Eastern Cooperative Oncology Group (ECOG) performance status \> 2 * Known active central nervous system (CNS) involvement * Peripheral neuropathy \> grade 1 if due to brentuximab vedotin or any peripheral neuropathy \> grade 2 * Intolerance to brentuximab vedotin * Concurrent use of other anti-cancer agents or experimental treatments * No current or prior autoimmune disease with the exception of vitiligo and autoimmune alopecia (Arm B only) * Pregnancy or breastfeeding; (females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin \[beta-hCG\] pregnancy test result within 7 days prior to the first dose of brentuximab vedotin; females with false positive results and documented verification that the patient is not pregnant are eligible for participation; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy; females of childbearing potential and males who have partners of childbearing potential must agree to use 2 effective contraceptive methods during the study and for 6 months following the last dose of brentuximab vedotin or 6 months following the last dose of nivolumab, whichever is later)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for CD30+ lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New combo therapy shows promise for tough lymphoma cases
- Supercharged immune cells aim to stop lymphoma comeback
- Double-Barreled attack: stem cell transplant plus CAR-T shows promise for Hard-to-Treat lymphoma
- Supercharged immune cells take on tough lymphoma
- Triple-Target CAR T-Cells offer new hope for tough blood cancers
- Blood cancer transplant study tests safer GVHD prevention