Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma (NCT04510636) | Clinical Trial Compass
RecruitingPhase 2
Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma
Canada37 participantsStarted 2021-12-20
Plain-language summary
This is a phase 2 open-label study to test the safety and effectiveness of combining pembrolizumab and bendamustine in patients with relapsed (cancer that has come back or started getting worse) or refractory (cancer that is not responding or has stopped responding to treatment) Hodgkin lymphoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Be willing and able to provide written informed consent for the trial and adhere to trial procedures.
* Have histologically confirmed relapsed (disease progression after most recent therapy) or refractory (failure to achieve complete response \[CR\] or partial response \[PR\] to most recent therapy) classical Hodgkin Lymphoma).
* Must have received at least standard first line chemotherapy for classical Hodgkin Lymphoma, containing an anthracycline.
* Must have failed or declined autologous stem cell transplantation (ASCT), or not be a candidate for ASCT.
* May have received prior therapy with pembrolizumab (or an equivalent checkpoint inhibitor or anti-PD-L1 antibody), but not in combination with bendamustine.
* May have received a prior autologous stem cell transplant but must be at least ≥100 days post-auto-transplant, and all transplant- related adverse events must have resolved to a grade 1 or less, and patients are not on immunosuppression, and meet all other eligibility criteria.
* Must have measurable or evaluable disease.
* Must have Eastern Cooperative Group (ECOG) performance status 0-1.
* Must have an estimated life expectancy of greater than 90 days.
* Demonstrate adequate organ and bone marrow function.
* If female of child-bearing potential, must have a negative pregnancy test within 72 hours prior to the first dose of study treatment.
* All participants must be willing to use adequate contraception for the duration of treatment with stud…
What they're measuring
1
Overall response rate
Timeframe: 5 years
2
Complete response rate as determined by Lugano criteria