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.
Title
- Brief Title: Brentuximab Vedotin With or Without Nivolumab in Treating Patients With Relapsed or Refractory CD30+ Lymphoma
- Official 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
Clinical Trial IDs
- ORG STUDY ID:
7808
- SECONDARY ID:
NCI-2012-01696
- SECONDARY ID:
7808
- SECONDARY ID:
P30CA015704
- SECONDARY ID:
RG1713010
- NCT ID:
NCT01703949
Conditions
- Recurrent Hodgkin Lymphoma
- Recurrent Non-Hodgkin Lymphoma
- Refractory Hodgkin Lymphoma
- Refractory Non-Hodgkin Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Brentuximab Vedotin | ADC SGN-35, Adcetris, Anti-CD30 Antibody-Drug Conjugate SGN-35, Anti-CD30 Monoclonal Antibody-MMAE SGN-35, Anti-CD30 Monoclonal Antibody-Monomethylauristatin E SGN-35, cAC10-vcMMAE, SGN-35 | Arm A (brentuximab vedotin) |
Nivolumab | BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo | Arm B (brentuximab vedotin, nivolumab) |
Purpose
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.
Detailed Description
OUTLINE:
ARM A (CLOSED TO ACCRUAL): Patients receive brentuximab vedotin intravenously (IV) over 30
minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the
absence of disease progression or unacceptable toxicity.
ARM B: Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30-60
minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3-5 weeks, every 3 months
for 1 year, and then every 6 months for 4 years.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A (brentuximab vedotin) | Experimental | Patients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. | |
Arm B (brentuximab vedotin, nivolumab) | Experimental | Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. | - Brentuximab Vedotin
- Nivolumab
|
Eligibility Criteria
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)
- 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
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 8 months
following the last dose of nivolumab, whichever is later)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall response rate as measured by the Cheson 2007 criteria |
Time Frame: | Up to 5 weeks after completion of study treatment |
Safety Issue: | |
Description: | No formal statistical measures will be pre-specified. This protocol will be deemed a "success" if the absolute response rate in this group of patients is >= 20%. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University of Washington |
Last Updated
June 8, 2021