Pembrolizumab + Chemotherapy for Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byJane Winter, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this research study is to evaluate a new drug pembrolizumab in combination with chemotherapy, for the treatment of newly diagnosed Hodgkin lymphoma. The chemotherapy regimen is called AVD and includes three drugs: adriamycin, vinblastin, dacarbazine. Pembrolizumab is currently FDA approved for the treatment of some patients with melanoma, lung cancer and head and neck cancer, but has not yet been approved for the treatment of Hodgkins Lymphoma. The AVD regimen of chemotherapy is currently FDA approved for the treatment of newly diagnosed Hodgkin lymphoma, but has not yet been investigated in combination with pembrolizumab for this disease. For patients who have a new diagnosis of Hodgkins Lymphoma, multi-agent chemotherapy is recommended. Also, for patients who do not have a complete response to chemotherapy (meaning there is still evidence of disease on PET scans performed at the end of treatment), radiation is sometimes recommended. Furthermore, the rare patient who relapses after chemotherapy requires treatment with high dose chemotherapy and a transplant.

Eligibility Criteria

This trial is for patients with newly diagnosed classical Hodgkin lymphoma who haven't been treated yet, except possibly a short course of steroids. They should be in good physical condition (ECOG 0-1), have measurable disease by Lugano criteria, and can have any stage or score. Key blood counts and liver function tests must meet specific levels.

Inclusion Criteria

My diagnosis is classical Hodgkin lymphoma, confirmed by a specific WHO classification.

Patients must have measurable disease by the Lugano criteria

FOCBP must have a negative pregnancy test within 7 days prior to registration

+6 more

Exclusion Criteria

I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks.

I have an immune system disorder or have taken steroids in the last week.

Patients with a history of allergic reactions to compounds similar to pembrolizumab

+13 more

Participant Groups

The study is testing pembrolizumab, a drug approved for other cancers but not yet for Hodgkin's lymphoma, combined with AVD chemotherapy (adriamycin, vinblastine, dacarbazine). The effectiveness of this combination will be evaluated using PET scans to monitor response to treatment.

1Treatment groups

Experimental Treatment

Group I: Treatment (FDG-PET/CT, pembrolizumab, chemotherapy)Experimental Treatment8 Interventions

See Detailed Description

Doxorubicin Hydrochloride is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Adriamycin for: