Condition: T-Cell Lymphoma · Sponsor: Yale University
This is a single arm, open label, multicenter study phase 2 study of pembrolizumab and brentuximab in subjects 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 \~55%. Pembrolizumab and brentuximab will be administered for 16 cycles in subjects with responsive disease. Pembrolizumab will be continued for an additional 19 cycles (total 35 cycles). Response assessments will occur at pre-specified intervals. For the primary endpoint the response assessment after 3 cycles will be taken into consideration. Dose adjustments for specific toxicities with either drug are detailed in the protocol. Based on statistical analysis 32 subjects will need to be accrued to evaluate for disease response based on historical control.
This description comes directly from the study's public registry record.
Stephanie Ladd, BS · 954-895-0576 · stephanie.ladd@yale.edu
Julie Holub · Julie.holub@yale.edu
Always discuss trial participation with your own doctor first.
| Yale Smilow Cancer Hospital | New Haven, Connecticut, United States | Recruiting |
| Dana Farber Cancer Institute | Boston, Massachusetts, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05313243