This study is looking at the effects of Ipilimumab when it is given alone or in combination with Nivolumab to patients with relapsed or refractory classic Hodgkin's lymphoma (cHL). The names of the study drugs involved in this study are: * Ipilimumab * Nivolumab
This is an open-label, multi-center, phase II study of ipilimumab with or without nivolumab for patients with relapsed or refractory (R/R) classic Hodgkin lymphoma (cHL). Nivolumab is a drug which is approved by the United States Food and Drug Administration (FDA) for the treatment of adult patients experiencing relapsed Hodgkin lymphoma (cHL) who have received at least two prior systemic therapies. Ipilimumab has been approved by the FDA for the treatment of metastatic melanoma (a type of skin cancer), and specific types of previously treated advanced kidney cancers. The study drugs have not been approved in combination for cHL by the Food and Drug Administration (FDA). This study is for participants who previously had progressive disease when receiving a PD-1 mAb. Participants will receive 4 cycles of ipilimumab monotherapy and then undergo restaging imaging. Patients who achieved an objective response will continue treatment with ipilimumab maintenance. Other patients will receive 4 cycles of nivolumab and ipilimumab followed by ipilimumab maintenance treatment. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are eligible to proceed to combination therapy with nivolumab and ipilimumab if they are clinically stable. Participants will receive up to \~ 24 months of study treatment. After completion of therapy, participants will be followed every 3 months for 2 years and then every 6 months for the next 5 years. It is expected that about 13 people will participate in this research study. Bristol Myers Squibb (BMS) is supporting this research study by providing the study drugs and funding for the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Intravenous infusion
Intravenous infusion
University of Chicago Medicine
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Overall Response Rate (ORR)
Patients achieving a complete (CR) or partial response (PR), assessed by PET/CT (using Lugano)
Time frame: From enrollment to completion of 4 cycles (each cycle is 21 days) of treatment
Overall Response Rate (ORR) Ipilimumab Monotherapy, Lugano
Patients achieving complete (CR) or partial response (PR), assessed by PET/CT (using Lugano criteria) after ipilimumab monotherapy
Time frame: 12 weeks
Overall Response Rate (ORR) Ipilimumab Monotherapy, LYRIC
Patients achieving complete (CR) or partial response (PR), assessed by PET/CT (using LYRIC criteria) after ipilimumab monotherapy
Time frame: 12 weeks
Complete Response Rate (CRR) Ipilimumab Monotherapy, Lugano
Patients achieving complete response (CR), assessed by PET/CT (using Lugano criteria) after ipilimumab monotherapy
Time frame: 12 weeks
Complete Response Rate (CRR) Ipilimumab Monotherapy, LYRIC
Patients achieving complete response (CR), assessed by PET/CT (using Lugano criteria) after ipilimumab monotherapy
Time frame: 12 weeks
Overall Response Rate (ORR) Ipilimumab and Nivolumab Combination Therapy, Lugano
Patients achieving complete (CR) or partial response (PR), assessed by PET/CT (using Lugano criteria) after ipilimumab and nivolumab combination therapy
Time frame: 24 weeks
Overall Response Rate (ORR) Ipilimumab and Nivolumab Combination Therapy, LYRIC
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Patients achieving complete (CR) or partial response (PR), assessed by PET/CT (using Lugano criteria) after ipilimumab and nivolumab combination therapy
Time frame: 24 weeks
Progression-free Survival, LYRIC
Percent of patients alive and progression-free at 2-years. Time from registration to progression or death, censored at date last known alive and progression-free using LYRIC criteria
Time frame: 2 years
Duration of Response
2-year percent DOR using Lugano criteria (LYRIC was equivalent). Time from first response (PR or CR) to progression, censored at last disease assessment.
Time frame: 2 years
Progression-free Survival, Lugano
Percent of patients alive and progression-free at 2-years. Time from registration to progression or death, censored at date last known alive and progression-free using Lugano criteria
Time frame: 2 years
Overall Survival
Percent OS at 2-years. Time from registration to death from any cause, censored at date last known alive
Time frame: 2 years
Percent of Patients With Grade 3+ Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
Worst grade adverse event attributable (possibly, probably, definitely) to study treatment. Descriptions and grading scales per NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 2 years