Pembrolizumab and Brentuximab Vedotin in Patients With Relapsed/Refractory T-cell Lymphoma
Status:
Not yet recruiting
Trial end date:
2028-07-30
Target enrollment:
Participant gender:
Summary
This is a single arm, open label, multicenter study phase 2 study of pembrolizumab and
brentuximab in patients with relapsed/refractory CD30 positive T-cell lymphoma (including
peripheral T-cell lymphoma and cutaneous T-cell lymphoma) who have received at least one
prior therapy. We hypothesize that this combination is effective and will produce an overall
response rate of ~65%. Pembrolizumab and brentuximab will be administered for 16 cycles in
patients with responsive disease. Pembrolizumab will be continued for an additional 19 cycles
(total 35 cycles). Response assessments will occur at pre-specified intervals. Dose
adjustments for specific toxicities with either drugs are detailed in the protocol. Based on
statistical analysis 43 patients will need to be accrued to evaluate for disease response
based on historical control.