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

Running, not enrolling · Phase 2

Conditions studied: Classic Hodgkin Lymphoma, Recurrent Hodgkin Lymphoma, Refractory Hodgkin Lymphoma

In brief

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 facts

Study ID

NCT03057795

Run by

City of Hope Medical Center

People needed

62

Starts

2017-04-03

Expected to finish

2027-02-25

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented informed consent
• Agreement to allow the use of archival tissue from pre-ASCT tumor biopsies
• If unavailable, exceptions may be granted with study principal investigator (PI) approval
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Histologically confirmed diagnosis of classical Hodgkin lymphoma (excluding nodular lymphocyte predominant Hodgkin lymphoma) according to the World Health Organization (WHO) classification, with hematopathology review at the participating institution
• Have high-risk relapsed or refractory Hodgkin lymphoma (HL), defined as at least one of the following:
• Primary refractory disease to front-line therapy
• Relapse within 1 year of completing front-line therapy
• Extranodal involvement at the time of pre-ASCT relapse
• B symptoms at pre-ASCT relapse
• More than one type of pre-ASCT salvage therapy required
• Planning to receive or have received autologous stem cell transplantation (ACST) per institutional standards as part of standard of care
• Pre-ASCT participants may consent but will not be eligible to begin treatment until after ASCT, and will have to fulfill all inclusion and exclusion criteria before starting protocol
• All participants must initiate day 1 of protocol therapy within 30-60 days post stem cell reinfusion; study PI can grant exception for a patient to start as late as 75 days post stem cell reinfusion with a reasonable justification for a delay (e.g. recovery from post -ASCT toxicity) and this will not be a protocol deviation, nor require an exception to be filled
• Recovery from ASCT toxicity as defined as outpatient status, able to drink, eat normally, and do not need intravenous hydration prior to day 1 of therapy
• Achieved at least stable disease to salvage treatment determined by positron emission tomography (PET)/computed tomography (CT) using 2014 Lugano Classification prior to ASCT
• Brentuximab vedotin naive OR had at least stable disease by Lugano Classification to prior brentuximab vedotin treatment
• Absolute neutrophil count (ANC) >= 1000/mm\^3
• Platelets >= 50,000/mm\^3
• Hemoglobin >= 8 g/dL
• Total bilirubin =< 1.5 x upper limit of normal (ULN) or 3 x ULN for Gilbert's disease
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN
• Creatinine clearance >= 40 mL/min per 24 hour urine collection or the Cockcroft-Gault formula
• Calculated per institutional standard
• Forced expiratory volume in one second (FEV1) and carbon monoxide diffusion capacity (DLCO) (adjusted for hemoglobin [Hb]) >= 50% adjusted

You may not qualify if…

• Post-ASCT anti-lymphoma or investigational therapy; immediate post-ASCT consolidative radiation therapy is allowed as long as it occurs prior to initiation of study therapy; baseline imaging and pulmonary function tests (PFTs) must be performed after completion of radiation
• Previous allogeneic transplant
• Total carmustine (BCNU) dose of > 600 mg/m\^2 with prior treatments including transplant conditioning regimen
• Live vaccine within 30 days prior to day 1 of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guerin [BCG], oral polio vaccine, and oral typhoid)
• Refractory to prior brentuximab vedotin (i.e. progression while on treatment)
• Refractory to prior anti-PD-1/PD-L1 agent
• History of prior >= grade 3 hypersensitivity to either brentuximab vedotin or nivolumab
• History of another primary malignancy that has not been in remission for at least 3 years; exceptions include:
• Basal cell carcinoma of the skin or
• Squamous cell carcinoma of the skin that has undergone potentially curative therapy or
• In situ cervical cancer
• Known active central nervous system (CNS) involvement by lymphoma, including parenchymal and/or lymphomatous meningitis
• History of progressive multifocal leukoencephalopathy (PML)
• Grade >= 2 peripheral neuropathy at the present time
• Prior diagnosis of inherited or acquired immunodeficiency
• Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration; exceptions are:
• Inhaled or topical steroids and
• Adrenal replacement doses > 10 mg daily prednisone equivalents in the absence of active autoimmune disease
• Uncontrolled illness including ongoing or active infection
• History of or active pneumonitis or interstitial lung disease:
• For history of pneumonitis to be an exclusion, patient had to have required supplemental oxygen or corticosteroid treatment; radiographic changes alone are not an exclusion
• An active, known or suspected autoimmune disease; the following are exceptions:
• Vitiligo
• Hemolytic anemia associated with the lymphoma (history of or at the present time)
• Type I diabetes mellitus

Where it is running

• City of Hope Medical Center — Duarte, California, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• M D Anderson Cancer Center — Houston, Texas, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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