Immunotherapy + Chemotherapy for Hodgkin's Lymphoma

Recruiting at 815 trial locations

Overseen By Rabi Hanna

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: National Cancer Institute (NCI)

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Organ transplant, CNS lymphoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 24-28 weeks

994 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic 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. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.

Who Is on the Research Team?

Alex F Herrera

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

This trial is for patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Eligible participants must be at least 12 years old, have measurable disease, and normal organ function. They should not be pregnant or nursing and agree to use contraception. Those with autoimmune diseases, prior malignancies (except certain treated cancers), or who received previous treatments for lymphoma are excluded.

Inclusion Criteria

I do not have any untreated or uncontrolled illnesses.

I have a tumor that is larger than 1.5 cm.

I am registered to receive PET radiation therapy for remaining cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chemotherapy and either nivolumab or brentuximab vedotin every 28 days for 6 cycles, with optional radiation therapy after cycle 6

24-28 weeks

Radiation

Participants may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-ups every 3 months for the first year, every 6 months for years 2 and 3, then annually until 10 years after registration

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Brentuximab Vedotin
• Dacarbazine
• Doxorubicin Hydrochloride
• Nivolumab
• Radiation Therapy
• Vinblastine Sulfate

Trial Overview The study compares the effectiveness of two immunotherapy drugs—nivolumab and brentuximab vedotin—combined with chemotherapy in treating Hodgkin lymphoma. It aims to see if adding these drugs can better shrink tumors or delay symptom return compared to standard chemotherapy alone.

How Is the Trial Designed?

Group I: Arm II (chemotherapy, brentuximab vedotin, radiation) Experimental Treatment 13 Interventions

Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.

Group II: Arm I (chemotherapy, nivolumab, radiation) Experimental Treatment 13 Interventions

Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.

Brentuximab Vedotin is already approved in United States, European Union for the following indications:

Approved in United States as Adcetris for:

• Hodgkin lymphoma
• Systemic anaplastic large cell lymphoma
• Primary cutaneous anaplastic large cell lymphoma
• CD30-expressing mycosis fungoides
• Peripheral T-cell lymphoma

Approved in European Union as Adcetris for:

• Hodgkin lymphoma
• Systemic anaplastic large cell lymphoma
• Cutaneous T-cell lymphoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+