NCT04795869

Brentuximab Vedotin and Pembrolizumab in Treating Patients With Recurrent Peripheral T-Cell Lymphoma

Phase II Study of Brentuximab Vedotin in Combination With Pembrolizumab in Patients With Recurrent Systemic Peripheral T-Cell Lymphoma (PTCL)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Angioimmunoblastic T-Cell Lymphoma
• Recurrent Enteropathy-Associated T-Cell Lymphoma
• Recurrent Follicular T-Cell Lymphoma
• Recurrent Hepatosplenic T-Cell Lymphoma
• Recurrent Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
• Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified
• Recurrent Subcutaneous Panniculitis-Like T-Cell Lymphoma
• Refractory Angioimmunoblastic T-Cell Lymphoma
• Refractory Enteropathy-Associated T-Cell Lymphoma
• Refractory Follicular T-Cell Lymphoma
• Refractory Hepatosplenic T-Cell Lymphoma
• Refractory Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
• Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
• Refractory Subcutaneous Panniculitis-Like T-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Brentuximab Vedotin	Given IV
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2020-03-01
• Primary completion: 2026-03-15
• Completion: 2029-03-01
• First posted: 2021-03-12
• Last updated: 2023-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study