RecruitingPhase 2NCT05313243

Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory T-cell Lymphoma

Phase 2 Study of Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory CD30 Positive T-cell Lymphoma

Sponsor

Yale University

Enrollment

32 participants

Start Date

Jul 10, 2023

Study Type

INTERVENTIONAL

Conditions

T-cell Lymphoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the combination of pembrolizumab (an immunotherapy) and brentuximab vedotin (a targeted antibody-drug) for people with T-cell lymphoma that has come back or stopped responding to prior treatments. T-cell lymphoma is a type of blood cancer that can be difficult to treat. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of T-cell Non-Hodgkin lymphoma (including types such as PTCL, AITL, ALCL, NK/T-cell lymphoma, or cutaneous T-cell lymphoma) - Your disease has relapsed (come back) or is refractory (did not respond) to prior treatments - Your general health is good (ECOG performance status 0–1) **You may NOT be eligible if...** - You have certain autoimmune conditions requiring systemic treatment - You have active brain metastases or active infections - You have had prior treatment with brentuximab vedotin or anti-PD1/PD-L1 therapies that resulted in severe side effects - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBrentuximab vedotin

Brentuximab vedotin is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL), a type of T cell non-Hodgkin lymphoma. It selectively targets tumor cells expressing the CD30 antigen, a defining marker of Hodgkin lymphoma and ALCL.

DRUGPembrolizumab

Pembrolizumab is a humanized antibody used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast cancer.