Immunotherapy + Chemotherapy for Hodgkin's Lymphoma

Recruiting at795 trial locations

Overseen by Alex F Herrera

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

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.

Research Team

Alex F Herrera

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

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.

Treatment Details

Interventions

• Brentuximab Vedotin (Monoclonal Antibodies)
• Dacarbazine (Anti-tumor antibiotic)
• Doxorubicin Hydrochloride (Anti-tumor antibiotic)
• Nivolumab (Monoclonal Antibodies)
• Radiation Therapy (Radiation)
• Vinblastine Sulfate (Vinca alkaloids)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School