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Clinical Trial Detail

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

Complete title: 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

Research Study Number 7808
Principal Investigator Ajay Gopal, MD
Phase II

Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older (Adult, Senior)

Sexes Eligible for Study: All

- 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)

- Resolution of all non-hematologic brentuximab vedotin-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

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- 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 8 months following the last dose of nivolumab, whichever is later)

Other exclusion criteria may apply.

Research Study Number 7808
Contact Seattle Cancer Care Alliance Intake Office
Telephone 800-804-8824 / 206-606-1024

Keywords: Lymphoma, Burkitt; Hematologic Malignancies; Leukemia; Lymphoma; Lymphoproliferative Disorders; Lymphoma, Non-Hodgkin (NHL); Waldenstrom Macroglobulinemia; Lymphoma, Mantle-Cell; Lymphoma, B-Cell; Lymphoma, T-Cell; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Follicular; Leukemia, B-Cell; Leukemia, T-Cell; Leukemia, Lymphocytic, Chronic, B-Cell

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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