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A Study of Brentuximab Vedotin and Nivolumab for Hodgkin Lymphoma

This study is comparing two ways to treat Hodgkin lymphoma (a type of cancer that starts in white blood cells called lymphocytes) in people aged 5 to 60. One approach uses standard chemotherapy (drugs like Bleomycin Sulfate and Cyclophosphamide). The other approach adds two drugs, Brentuximab Vedotin and Nivolumab, to the standard treatment. Brentuximab Vedotin is an antibody-drug conjugate, meaning it's a targeted treatment that delivers medicine directly to cancer cells. Nivolumab is an immunotherapy, which helps your body's immune system fight cancer. The study aims to see if adding these drugs improves how long people live without their cancer getting worse (progression-free survival). The study is currently recruiting and plans to enroll 1875 participants.

Study design
This is an interventional study comparing standard chemotherapy to chemotherapy plus Brentuximab Vedotin and Nivolumab. It plans to enroll 1875 participants.
What's involved
You would undergo blood sample collection and imaging tests like CT scans or PET-CT scans. You would receive intravenous (IV) medications.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be measured for up to 3 years after the last patient is randomized.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05675410

A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab

Recruiting
PHASE3Ages 5–60InterventionalTreatment
National Cancer Institute (NCI)
~1,875 participants
Updated 2026-09-15 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBleomycin SulfateBrentuximab VedotinComputed TomographyCyclophosphamideDacarbazine

At a glance

Recruiting sites
399 of 414 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS) in rapid early responder (RER) patients
Measured over From the time of randomization to the earliest time of disease relapse, progression, or death due to any cause, assessed up to 3 years after the randomization of the last patient or when reaching 124 events, whichever comes first
+1 more outcome measured

Conditions

Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8

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NCT05675410

Where you'd take part

This study runs at 414 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

  • AdventHealth Orlando

    Orlando, Floridastudy coordinator listed

    Recruiting

  • Advocate Children's Hospital-Oak Lawn

    Oak Lawn, Illinoisstudy coordinator listed

    Recruiting

  • Advocate Children's Hospital-Park Ridge

    Park Ridge, Illinoisstudy coordinator listed

    Recruiting

  • Advocate Christ Medical Center

    Oak Lawn, Illinoisstudy coordinator listed

    Recruiting

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinoisstudy coordinator listed

    Recruiting

  • Advocate Good Shepherd Hospital

    Barrington, Illinoisstudy coordinator listed

    Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kara M Kelly · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

Who to contact

Site Public Contact
[email protected]
205-638-9285
Email the study team

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Eligibility criteria

Inclusion

Patients must be 5 to 60 years of age at the time of enrollment
Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified \[NOS\]) with stage I or II disease
Patients must have bidimensionally measurable disease (at least one lesion with longest diameter \>= 1.5 cm)
Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained
Pediatric patients (age 5-17 years) with known or suspected mediastinal disease must have an upright posteroanterior (PA) chest X-ray (CXR) for assessment of bulky mediastinal disease.
Note: Pediatric patients who have received both a CT chest and upright PA CXR may meet the definition of bulk through either modality.
Patients \>= 18 years must have a performance status corresponding to Zubrod scores of 0, 1 or 2
Patients =\< 17 years of age must have a Lansky performance score of \>= 50
Pediatric patients (age 5-17 years): A serum creatinine based on age/sex as follows (within 28 days prior to enrollment):
2 to \< 6 years (age): 0.8 mg/dL (male), 0.8 mg/dL (female)
6 to \< 10 years (age): 1 mg/dL (male), 1 mg/dL (female)
10 to \< 13 years (age): 1.2 mg/dL (male), 1.2 mg/dL (female)
13 to \< 16 years (age): 1.5 mg/dL (male), 1.4 mg/dL (female)
\>= 16 years (age): 1.7 mg/dL (male), 1.4 mg/dL (female) OR a 24 hour urine creatinine clearance \>= 50 mL/min/1.73 m\^2 (within 28 days prior to enrollment) OR a glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2 (within 28 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility
For adult patients (age 18 years or older) (within 28 days prior to enrollment): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight
Total bilirubin =\< 2 x upper limit of normal (ULN) (within 28 days prior to enrollment)
Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
Aspartate aminotransferase (AST) =\< 3 x ULN (within 28 days prior to enrollment)
Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
Alanine aminotransferase (ALT) =\< 3 x ULN (within 28 days prior to enrollment)
Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
Shortening fraction of \>= 27% by echocardiogram (ECHO), multigated acquisition scan (MUGA), or functional cardiac imaging scan (within 28 days prior to enrollment) or ejection fraction of \>= 50% by radionuclide angiogram, ECHO, MUGA, or cardiac imaging scan (within 28 days prior to enrollment)
Diffusion capacity of the lung for carbon monoxide (DLCO) \>= 50% of predicted value as corrected for hemoglobin by pulmonary function test (PFT) (within 28 days prior to enrollment). If unable to obtain PFTs, the criterion is: a pulse oximetry reading of \> 92% on room air
Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

Exclusion

Patients with nodular lymphocyte predominant Hodgkin lymphoma
Patients with a history of active interstitial pneumonitis or interstitial lung disease
Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients
Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, and gastrointestinal disorders affecting swallowing and/or absorption of pills
Patients with a condition requiring systemic treatment with either corticosteroids (defined as equivalent to \> 10 mg daily predniSONE for patients \>= 18 years or \> 0.5 mg/kg \[up to 10 mg/day\] for patients \< 18 years) or other immunosuppressive medications within 14 days prior to enrollment
Note: Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment. Inhaled or topical steroids, and adrenal replacement doses (=\< 10 mg daily for patients \>= 18 years or =\< 0.5 mg/kg \[up to 10 mg/day\] predniSONE equivalents) are permitted in the absence of active autoimmune disease
Note: Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued by cycle 1, day 1
Short term use of corticosteroids for premedication or treatment of an allergy or hypersensitivity is considered an acceptable use of corticosteroids.
Patients with peripheral neuropathy \> grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL
Prior solid organ transplant
Prior allogeneic stem cell transplantation
Live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, bacillus Calmette Guerin \[BCG\], oral polio vaccine, and oral typhoid). Administration of messenger ribonucleic acid (mRNA) vaccines are permitted
Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test within 28 days prior to enrollment is required for female patients of childbearing potential
Lactating females who plan to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last treatment
Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method for the duration of their study drug therapy. Following therapy, patients will be advised to use contraception as per institutional practice or as listed below for investigational agents, whichever is longer
Men and women of childbearing potential (WOCBP) must use effective contraception during the study and for 2 months for WOCBP and 4 months for men, after last dose of brentuximab vedotin
WOCBP must continue contraception for a period of at least 5 months after the last dose of nivolumab
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

What this trial measures

  • Progression-free survival (PFS) in rapid early responder (RER) patientsFrom the time of randomization to the earliest time of disease relapse, progression, or death due to any cause, assessed up to 3 years after the randomization of the last patient or when reaching 124 events, whichever comes first

    Will compare the PFS of RER patients randomized to immunotherapy (IO) therapy (brentuximab vedotin-nivolumab) against those randomized to standard therapy. PFS curves will be estimated separately by arm using Kaplan Meier methodology, and the test will be a 1-sided log-rank test between the (pooled) IO and standard arms, stratified according to the stratification factors at randomization and including all eligible and evaluable randomized patients.

  • PFS in slow-early responder (SER) patientsFrom the time of randomization to the earliest time of disease relapse, progression, or death due to any cause, assessed up to 3 years after the randomization of the last patient or when reaching 71 events, whichever comes first

    Will compare PFS among SER patients randomized to IO therapy and involved-site radiation therapy against arms containing standard therapy. PFS curves will be estimated separately by arm using Kaplan Meier methodology, and the test will be a 1-sided log-rank test between the (pooled) IO and standard arms, stratified according to the stratification factors at randomization and including all eligible and evaluable randomized patients.