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.
Additional locations may be listed on ClinicalTrials.gov for NCT03331341.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To estimate the safety of delivering 2 cycles doxorubicin hydrochloride (adriamycin), pembrolizumab, vinblastine and dacarbazine (APVD) to patients with previously untreated classical Hodgkin lymphoma (cHL). (Part A)
II. To estimate the 1-year event free survival (EFS) for advanced stage patients treated with APVD. An event will be defined as progression, biopsy proven recurrence, initiation of next line of chemotherapy, or death. (Part B)
SECONDARY OBJECTIVE:
I. To estimate the fludeoxyglucose F-18 (FDG)-positron emission tomography (PET) 2 negative (Deauville score 1-3) rate after 2 cycles of APVD.
EXPLORATORY OBJECTIVES:
I. Overall survival, association of biomarkers with early complete response (CR).
II. Predictive capacity of PET2 after APVD.
III. To evaluate the impact of APVD on T-cell repertoire and diversity.
IV. To evaluate the ability of this regimen to attain minimal residual disease as measured by next generation sequencing (NGS).
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.
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorRyan Lynch