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

Sponsor
University of Washington (Other)
Overall Status
Recruiting
CT.gov ID
NCT01703949
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
117.9
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Brentuximab Vedotin
  • Other: Laboratory Biomarker Analysis
  • Biological: Nivolumab
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 20, 2013
Anticipated Primary Completion Date :
Jan 15, 2023
Anticipated Study Completion Date :
Jan 15, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Arm A (brentuximab vedotin)

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
Given IV
Other Names:
  • 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
  • Other: Laboratory Biomarker Analysis
    Correlative studies

    Experimental: Arm B (brentuximab vedotin, nivolumab)

    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
    Given IV
    Other Names:
  • 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
  • Other: Laboratory Biomarker Analysis
    Correlative studies

    Biological: Nivolumab
    Given IV
    Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
  • Outcome Measures

    Primary Outcome Measures

    1. Overall response rate as measured by the Cheson 2007 criteria [Up to 5 weeks after completion of study treatment]

      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%.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Fred Hutch/University of Washington Cancer ConsortiumSeattleWashingtonUnited States98109

    Sponsors and Collaborators

    • University of Washington

    Investigators

    • Principal Investigator: Ajay K. Gopal, Fred Hutch/University of Washington Cancer Consortium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Washington
    ClinicalTrials.gov Identifier:
    NCT01703949
    Other Study ID Numbers:
    • 7808
    • NCI-2012-01696
    • 7808
    • RG1713010
    First Posted:
    Oct 11, 2012
    Last Update Posted:
    Jan 5, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 5, 2022