๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-11-05

Brentuximab Vedotin and Nivolumab in Treating Patients With Early Stage Classic Hodgkin Lymphoma (NCT03712202)

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: City of Hope Medical Center

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This phase II trial studies how well brentuximab vedotin and nivolumab work in treating patients with stage I-II classic Hodgkin lymphoma. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (17 items).

Location: University of Alabama at Birmingham Cancer Center โ€” Birmingham, Alabama

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Patients must be naive in terms of any prior therapy for Hodgkin lymphoma (including immunotherapy, chemotherapy or radiation therapy) with the exception that they may have received up to 2 cycles of ABVD as standard of care therapy prior to enrollment, as long as they can start protocol therapy (therapy administered in Arms A, B1/B2, or C) within timelines specified by the trial.
  • Peripheral sensory neuropathy \> grade 1 or any peripheral motor neuropathy.
  • History of another primary malignancy that has not been in remission for at least 3 years. (The following are exempt from the 3-year limit: nonmelanoma skin cancer, fully excised melanoma in situ \[Stage 0\], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolau \[PAP\] smear)
  • Known cerebral/meningeal disease.
  • History of progressive multifocal leukoencephalopathy (PML).
  • Known history of pancreatitis.
  • Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association class III-IV within 6 months prior to enrollment
  • Uncontrolled cardiac disease including ventricular dysfunction, left ventricular ejection fraction \< 45%, coronary artery disease, or arrhythmias.
  • Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin, nivolumab, or any component of ABVD.
  • Known active infection with hepatitis B or hepatitis C. Patients who are hepatitis B carriers can enroll if have a negative hepatitis B polymerase chain reaction (PCR) DNA test and are on hepatitis B suppressive medication management with entecavir or lamivudine. Patients with past active hepatitis C virus (HCV) infection are eligible if they are PCR negative after curative therapy. Testing to be done only in patients suspected of having infections or exposures.
  • Known active infection with human immunodeficiency virus (HIV). Patients who are HIV positive can enroll if CD4 count is \> 200/uL and have an undetectable or unquantifiable HIV viral load within 28 days of enrollment, have concurrent management with infectious disease specialists, and are on stable combination antiretroviral therapy. Participants are required to be on antiretroviral regimens that are in accordance with the current International acquired immune deficiency syndrome (AIDS) Society guidelines concurrently with chemotherapy. The specific agents are at the discretion of the Investigator and the use of investigational agents currently available on an expanded access basis is allowed. Use of experimental antiretroviral agents or those containing zidovudine (including Combivir and Trizivir) or ritonavir (includes Norvir or Kaletra), Cobicistat, Didanosine (Videx or Videx EC), or similar potent CYP3 inhibitors are prohibited. In order to be eligible, participants taking zidovudine or ritonavir, Cobicistat, Didanosine, or other CYP3 inhibitors must change to a different regimen 7 days prior to therapy initiation. Changes to highly active antiretroviral therapy (HAART) therapy during the study may be made if medically necessary (toxicity, failure of regimen, etc.). Participants must be on HAART for at least 7 days prior to therapy. HIV testing to be done only in patients suspected of having infections or exposures

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

๐Ÿ“ All Participating Trial Locations (17 Sites)

  • University of Alabama at Birmingham Cancer Center โ€” Birmingham, Alabama
  • City of Hope Medical Center โ€” Duarte, California
  • University of California San Diego โ€” San Diego, California
  • Emory University Hospital/Winship Cancer Institute โ€” Atlanta, Georgia
  • Northwestern University โ€” Chicago, Illinois
  • University of Chicago Comprehensive Cancer Center โ€” Chicago, Illinois
  • Beth Israel Deaconess Medical Center โ€” Boston, Massachusetts
  • Dana-Farber Cancer Institute โ€” Boston, Massachusetts
  • Massachusetts General Hospital โ€” Charlestown, Massachusetts
  • Hackensack University Medical Center โ€” Hackensack, New Jersey
  • NYP/Weill Cornell Medical Center โ€” New York, New York
  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center โ€” Cleveland, Ohio
  • Ohio State University Comprehensive Cancer Center โ€” Columbus, Ohio
  • University of Pennsylvania/Abramson Cancer Center โ€” Philadelphia, Pennsylvania
  • Sarah Cannon Cancer Center โ€” Nashville, Tennessee
  • M D Anderson Cancer Center โ€” Houston, Texas
  • Huntsman Cancer Institute/University of Utah โ€” Salt Lake City, Utah

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
๐Ÿ›๏ธ View Official NIH Record โ†—