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

NCT01703949 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: 7808NCI-2012-01696RG1713010
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Hodgkin Lymphoma; Recurrent Non-Hodgkin Lymphoma; Refractory Hodgkin Lymphoma; Refractory Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate as measured by the Cheson 2007 criteria

  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% in Arm A or ≥40% in Arm B.

  For Arm A: Up to 5 weeks after completion of study treatment. For Arm B: within 6 months following treatment.

Study Arms (2)

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.

Drug: Brentuximab Vedotin; Other: Laboratory Biomarker Analysis

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.

Drug: Brentuximab Vedotin; Other: Laboratory Biomarker Analysis; Biological: Nivolumab

Interventions

Brentuximab Vedotin DRUG

Given IV

Also known as: 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); Arm B (brentuximab vedotin, nivolumab)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm A (brentuximab vedotin); Arm B (brentuximab vedotin, nivolumab)

Nivolumab BIOLOGICAL

Given IV

Also known as: BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo, CMAB819, Nivolumab Biosimilar CMAB819

Arm B (brentuximab vedotin, nivolumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin

Interventions

Brentuximab Vedotin; Nivolumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Ajay K. Gopal

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: October 11, 2012
• Study Start: March 20, 2013
• Primary Completion: June 3, 2025
• Study Completion (Estimated): June 3, 2030
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

US (1)