This phase II trial studies the side effects of doxorubicin hydrochloride, pembrolizumab, vinblastine, and dacarbazine in treating patients with classical Hodgkin lymphoma. Drugs used in chemotherapy, such as doxorubicin hydrochloride, 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. Immunotherapy with pembrolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving doxorubicin hydrochloride, pembrolizumab, vinblastine, and dacarbazine may work better in treating classical Hodgkin lymphoma.
OUTLINE: PART A: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine IV, and dacarbazine IV on days 1 and 15. Patients also receive pembrolizumab IV over 30 minutes on days 1 and 22 of cycle 1 and on day 15 of cycle 2. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. PART B: Patients receive doxorubicin hydrochloride IV, vinblastine IV, dacarbazine IV, and pembrolizumab IV as in part A, but undergo a total of 6 treatment cycles. After completion of study treatment, patients are followed up at 30 days and then up to 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Given IV
Given IV
Correlative studies
Given IV
Given IV
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
PART A: Number of Participants Who Complete of 2 Cycles of Adriamycin, Pembrolizumab, Vinblastine and Dacarbazine (APVD)
Number of participants who complete 2 cycles of treatment without a dose delay of \>3 weeks. Toxicity leading to dose delay will be assessed using CTCAE v5.0.
Time frame: At the end of Cycle 2 (each cycle is 28 days)
PART B: Event Free Survival at 1 Year
Number of participants who are event free at 1 year. An event is defined as progression, biopsy proven recurrence, initiation of next line of chemotherapy, or death.
Time frame: At the end of 1 year after completing 2 cycles of treatment (each cycle is 28 days)
Proportion of Fludeoxyglucose F-18 (FDG)-Positron Emission Tomography PET2 Negative (Deauville Score 1-3) Patients After 2 Cycles of APVD
The Deauville 5 point scale is scored as follows: 1, no uptake above background; 2, uptake ≤ mediastinum; 3, uptake \> mediastinum but ≤ liver; 4, uptake moderately \> liver; 5, uptake markedly higher than liver and/or new lesions; X, new areas of uptake unlikely to be related to lymphoma.
Time frame: After 2 cycles (each cycle is 28 days)
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