Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT03057795
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Classic Hodgkin Lymphoma
  • Recurrent Hodgkin Lymphoma
  • Refractory Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • Brentuximab Vedotin — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial studies how well nivolumab and brentuximab vedotin work after stem cell transplant in treating patients with high-risk classical Hodgkin lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as nivolumab and brentuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Key Dates

Start date
Apr 3, 2017
Status verified
Apr 2026
Primary completion
Jan 30, 2021
Completion
Feb 25, 2027

Study Design

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

Arms

  • Experimental: Treatment (brentuximab vedotin, nivolumab)
    Beginning 30-60 days post-ASCT, patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival at 18 Months [ Time Frame: From the first dose of study treatment to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed at 18 months. ]

Locations (6)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
Mayo Clinic in RochesterRochesterMinnesota55905-
Hackensack University Medical CenterHackensackNew Jersey07601-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
M D Anderson Cancer CenterHoustonTexas77030-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CAMayo Clinic in Rochester· Rochester, MNHackensack University Medical Center· Hackensack, NJMemorial Sloan Kettering Cancer Center· New York, NYM D Anderson Cancer Center· Houston, TXFred Hutchinson Cancer Research Center· Seattle, WA

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