Nivolumab and Brentuximab Vedotin in Treating Older Patients With Untreated Hodgkin Lymphoma

Part of paid clinical trials in Palo Alto, California.

Sponsor
Academic and Community Cancer Research United
Study ID
NCT02758717
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Ann Arbor Stage IB Hodgkin Lymphoma
  • Ann Arbor Stage II Hodgkin Lymphoma
  • Ann Arbor Stage IIA Hodgkin Lymphoma
  • Ann Arbor Stage IIB Hodgkin Lymphoma
  • Ann Arbor Stage III Hodgkin Lymphoma
  • Ann Arbor Stage IIIA Hodgkin Lymphoma
  • Ann Arbor Stage IIIB Hodgkin Lymphoma
  • Ann Arbor Stage IV Hodgkin Lymphoma
  • Ann Arbor Stage IVA Hodgkin Lymphoma
  • Ann Arbor Stage IVB Hodgkin Lymphoma
  • Classic Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brentuximab Vedotin — DRUG
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial studies how well nivolumab and brentuximab vedotin work in treating older patients with untreated Hodgkin lymphoma. 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. Biological therapies, such as brentuximab vedotin, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Nivolumab and brentuximab vedotin may work better in treating older patients with untreated Hodgkin lymphoma.

Key Dates

Start date
May 13, 2016
Status verified
Aug 2025
Primary completion
Aug 13, 2019
Completion
Sep 13, 2025

Study Design

Enrollment
46 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (brentuximab vedotin, nivolumab)
    Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for 7 cycles and 6-8 weeks in cycle 8 in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall Metabolic Response Rate [ Time Frame: Up to 8 cycles of treatment (approximately 29 weeks) ]

Locations (9)

FacilityCityStateZIPSite coordinators
Stanford Cancer Institute Palo AltoPalo AltoCalifornia94304-
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Mayo ClinicRochesterMinnesota55905-
Washington University School of MedicineSt LouisMissouri63110-
Hackensack University Medical CenterHackensackNew Jersey07601-
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
Stanford Cancer Institute Palo Alto· Palo Alto, CAMedStar Georgetown University Hospital· Washington D.C., DCEmory University Hospital/Winship Cancer Institute· Atlanta, GAMayo Clinic· Rochester, MNWashington University School of Medicine· St Louis, MOHackensack University Medical Center· Hackensack, NJ

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