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NCT01703949Active, not recruitingPhase 2

Brentuximab Vedotin With or Without Nivolumab in Treating Patients With Relapsed or Refractory CD30+ Lymphoma

A Pilot Study of Weekly Brentuximab Vedotin or Brentuximab Vedotin Plus Nivolumab Every 3 Weeks in Patients With CD30+ Malignancies Refractory to Every ≥ 3 Week Brentuximab Vedotin

Source: ClinicalTrials.gov · Last updated 12 May 2026

Brief summary (registry, in English)

This phase II pilot trial studies how well brentuximab vedotin with or without nivolumab works in treating patients with CD30+ lymphoma that has come back after a period of improvement or does not respond to treatment. Biological therapies, such as brentuximab vedotin, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as nivolumab may interfere with the ability of tumor cells to grow and spread. Giving brentuximab vedotin with or without nivolumab may work better in treating patients with CD30+ lymphoma.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
28 (actual)
First submitted
8 Oct 2012
Start date
20 Mar 2013
Primary completion date
3 Jun 2025
Lead sponsor
University of Washington
NCT number
NCT01703949

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 28
  • From 20 Mar 2013 to the primary completion date, 3 Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior transplant within 100 days
  • Known human immunodeficiency virus (HIV) or hepatitis B positivity or prior progressive multifocal leukoencephalopathy (PML)
  • 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)

Other illness

  • 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

Lab values

  • 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)

Other

  • Radioimmunotherapy within 12 weeks
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fred Hutch/University of Washington Cancer Consortium
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.