Phase II Trial of Pembrolizumab in Combination With ICE Salvage Chemotherapy for Relapsed/Refractory Hodgkin Lymphoma

Who is this study for? Adult patients with Hodgkin's Lymphoma
What treatments are being studied? Pembrolizumab
Status: Unknown
Location: See all (6) locations...
Intervention Type: Drug, Other, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this research study is to evaluate a new drug Pembrolizumab in combination with chemotherapy, for Relapsed/Refractory Hodgkin Lymphoma. The chemotherapy regimen is called ICE and includes three drugs: ifosfamide, carboplatin, and etoposide. Pembrolizumab is currently Food and Drug Administration (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 Relapsed/Refractory Hodgkin Lymphoma. The 'ICE' regimen of chemotherapy is currently FDA approved for the treatment of Relapsed/Refractory Hodgkin Lymphoma, but has not yet been investigated in combination with pembrolizumab for this disease. For patients who have a relapse of their Hodgkin's lymphoma, retreatment with chemotherapy followed by a stem cell transplant is recommended. We know that obtaining a complete remission (not able to detect any disease on scans) is very important prior to proceeding to the stem cell transplant. Patients with negative scans have a lower chance of the disease coming back and a higher chance of achieving a long-term cure.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients must have histologically confirmed diagnosis of classical Hodgkin lymphoma including nodular sclerosis, mixed cellularity, lymphocytic-rich, and lymphocyte depleted subtypes by the 4th edition of the World Health Organization (WHO) Classification of Tumors of Hematopoietic and Lymphoid Tissues published in 2008

• Patients must have disease with FDG-PET/CT avidity

• Patients must have relapsed/refractory disease, with at least one line of prior chemotherapy, but =\< 2 prior lines of treatment, for Hodgkin lymphoma; NOTE: Patients must not have had prior immune checkpoint inhibitors; however, there are no other limitations to prior agent or regimen types

• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• Patients must have adequate organ and bone marrow function within 10 days of registration, as defined below:

• Absolute neutrophil count \>= 1,000/mcL (in the absence of granulocyte colony stimulating factor (GCSF) for \>= 14 days)

• Platelets \>= 75,000/mcl (in the absence of platelet transfusion for \>= 14 days)

• Hemoglobin \>= 7g/dL (transfusion permitted)

• Total bilirubin =\< 2 x institutional upper limit of normal (ULN); if total bilirubin is \> 2 x ULN, the direct bilirubin must be normal

• Aspartate aminotransferases (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SPGT\]) =\< 2.5 x institutional ULN

• Creatinine =\< 2 x ULN or creatinine clearance (CrCl) \> 30 ml/min

• Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to registration; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

• Females of childbearing potential (FOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

‣ Has not undergone a hysterectomy or bilateral oophorectomy

⁃ Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months) NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject

• Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy

• Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Locations
United States
Georgia
Winship Cancer Institute of Emory University
Atlanta
Augusta University Medical Center
Augusta
Illinois
Northwestern University
Chicago
Loyola University Medical Center
Maywood
New Jersey
Hackensack University Medical Center
Hackensack
New York
University of Rochester
Rochester
Time Frame
Start Date: 2017-04-21
Completion Date: 2024-12
Participants
Target number of participants: 43
Treatments
Experimental: Treatment (pembrolizumab, etoposide, carboplatin, ifosfamide)
Patients receive pembrolizumab IV over 30 minutes on day 1, etoposide IV over 60 minutes on days 1-3 of courses 1-2, carboplatin IV over 60 minutes on day 2 of courses 1-2, and ifosfamide IV over 24 hours on day 2 of courses 1-2. Pembrolizumab in combination with ICE chemotherapy repeats every 21 days for 2 courses, patients will then receive pembrolizumab as monotherapy on course 3.
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC, National Cancer Institute (NCI)
Leads: Northwestern University

This content was sourced from clinicaltrials.gov

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