NCT05675410 · National Cancer Institute (NCI)
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
What this study is about
This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates.
View original scientific description
This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin.
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
BIOLOGICAL
Bleomycin Sulfate
Given IV
DRUG
Brentuximab Vedotin
Given IV
PROCEDURE
Computed Tomography
Undergo CT and/or PET-CT
DRUG
Cyclophosphamide
Given IV
DRUG
Dacarbazine
Given IV
DRUG
Doxorubicin Hydrochloride
Given IV
DRUG
Etoposide
Given IV
DRUG
Etoposide Phosphate
Given IV
OTHER
Fludeoxyglucose F-18
Undergo FDG-PET
RADIATION
Involved-site Radiation Therapy
Undergo ISRT
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI and/or PET-MRI
BIOLOGICAL
Nivolumab
Given IV
PROCEDURE
Positron Emission Tomography
Undergo FDG-PET, PET, PET-CT, and/or PET-MRI
DRUG
Prednisolone
Given PO
DRUG
Prednisone
Given PO
DRUG
Procarbazine Hydrochloride
Given PO
OTHER
Questionnaire Administration
Ancillary studies
DRUG
Vinblastine Sulfate
Given IV
DRUG
Vincristine Sulfate
Given IV
Primary outcome measures
Progression-free survival (PFS) in rapid early responder (RER) patients
Time frame: 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
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) patients
Time frame: 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 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Birmingham, Alabama
- Mobile, Alabama
- Anchorage, Alaska
- Goodyear, Arizona
- Mesa, Arizona
- Phoenix, Arizona
- Little Rock, Arkansas
- Carmichael, California
- Corona, California
- Costa Mesa, California
- Downey, California
- Duarte, California
And 283 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations