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Spots Global Cancer Trial Database for Brentuximab Vedotin and Pembrolizumab in Treating Patients With Recurrent Peripheral T-Cell Lymphoma

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Study Description

Brief Summary: This phase II clinical trial studies how well giving brentuximab vedotin together with pembrolizumab in treating patients with peripheral T-cell lymphoma (PTCL) that has come back (recurrent). Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Pembrolizumab is an antibody-drug that stimulates body's natural antitumor immune responses. Giving brentuximab vedotin together with pembrolizumab may work better than brentuximab vedotin alone in treating patients with recurrent peripheral T-cell lymphoma.

Detailed Description: PRIMARY OBJECTIVE: I. To assess the antineoplastic efficacy of brentuximab vedotin in combination with pembrolizumab in previously treated patients with PTCL, as measured by the overall objective response rate (ORR). SECONDARY OBJECTIVES: I. To determine the safety and tolerability of brentuximab vedotin in combination with pembrolizumab. II. To assess efficacy using duration of objective response (DOR), time to response (TTR), progression free survival (PFS), and overall survival (OS). OUTLINE: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1, and pembrolizumab IV over 30 minutes on day 3 of cycle 1, day 1 of subsequent cycles. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles of treatment, patients may discontinue treatment if they experience disease progression, are eligible for stem cell transplant, or if they elect to not undergo stem cell transplantation (SCT). After completion of study treatment, patients are followed up to 5 years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Northwestern University, Chicago, Illinois, United States

Contact Details

Name: Jonathan Moreira, MD

Affiliation: Northwestern University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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