Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Grade 3b Follicular Lymphoma
  • Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma
  • Refractory Follicular Lymphoma
  • Recurrent Classic Hodgkin Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
  • Recurrent Follicular Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Refractory Classic Hodgkin Lymphoma
  • Refractory Diffuse Large B Cell Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Refractory Transformed Non-Hodgkin Lymphoma
  • Recurrent Grade 3a Follicular Lymphoma
  • Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
  • Recurrent Transformed Non-Hodgkin Lymphoma
  • Refractory B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. To assess the safety and tolerability of vorinostat plus pembrolizumab therapy by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration. II. To determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of...

PRIMARY OBJECTIVES: I. To assess the safety and tolerability of vorinostat plus pembrolizumab therapy by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration. II. To determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of vorinostat when given in combination with pembrolizumab. SECONDARY OBJECTIVE: I. To obtain preliminary estimates of the anti-tumor activity of pembrolizumab plus vorinostat therapy by assessing the overall response rate (ORR), complete response (CR) rate, duration of response (DOR), overall survival (OS) and progression-free survival (PFS). EXPLORATORY OBJECTIVES: I. Evaluate responses and disease progression according to the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC). II. Explore genomic biomarkers of response and resistance to pembrolizumab plus vorinostat therapy in patients with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), or Hodgkin lymphoma (HL). III. Explore immunologic biomarkers of response and resistance to pembrolizumab plus vorinostat therapy in patients with DLBCL, FL, or HL. IV. Explore the value of circulating deoxyribonucleic acid (DNA) (ctDNA) as a biomarker of response to pembrolizumab plus vorinostat therapy. OUTLINE: This is a dose-escalation study of vorinostat. Patients receive vorinostat orally (PO) twice daily (BID) on days 1-5 and 8-12 and pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, and then every 12 weeks.

Tracking Information

NCT #
NCT03150329
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Alex F Herrera City of Hope Medical Center