Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

An International, Phase 2, Open-Label, Efficacy and Safety Study of MDV9300 in Patients With an Incomplete Response Following Salvage Therapy or Autologous Stem Cell Transplantation for Relapsed or Refractory CD20+ Diffuse Large B-Cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of MDV9300 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that have achieved either stable disease or a partial remission following definitive salvage therapy.

Two cohorts of patients will be enrolled: a cohort treated with salvage chemotherapy but considered ineligible for autologous stem cell transplant (ASCT), and a cohort of patients who have received ASCT following salvage chemotherapy.

Study Overview

• Status: Withdrawn
• Conditions: Lymphoma, Large B-Cell, Diffuse; Primary Mediastinal Large B-cell Lymphoma; Transformed Indolent Lymphoma
• Intervention / Treatment: Biological: MDV9300

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years or older and willing and able to provide informed consent;
• Histologically confirmed relapsed or refractory CD20+ DLBCL, transformed indolent lymphoma (follicular or other), or primary mediastinal large B-cell lymphoma;
• Received prior treatment with a standard anthracycline and therapeutic anti-CD20 monoclonal antibody-based regimen;
• For transplant-ineligible patients, salvage therapy just prior to MDV9300 treatment must have resulted in a PR or stable disease;
• For post autologous stem cell transplant (ASCT) patients, salvage therapy plus ASCT just prior to MDV9300 treatment must have resulted in a PR or stable disease;
• Adequate bone marrow reserve as defined per protocol;
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. Patients with stable ECOG scores of 2 may be allowed with medical monitor approval.

Exclusion Criteria:

• Burkitt, mantle cell, follicular, or mucosa-associated lymphoid tissue lymphoma
• History of serious autoimmune disease;
• History of central nervous system involvement of lymphoma;
• Prior therapy with agents targeting immune coinhibitory receptors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MDV9300	Biological: MDV9300; MDV9300 will be administered at a dose of 200 mg by intravenous (IV) infusion every 2 weeks until treatment discontinuation criteria are met.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best overall response rate	Defined as the proportion of patients in the intent-to-treat population with a complete response (CR) or partial response (PR) attributable to study treatment, as assessed by the independent review committee (IRC).	no later than 6 months after the last patient is enrolled in a cohort

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of response (for responders)	Defined as the time from the first objective evidence of CR or PR as assessed by the IRC to the first objective evidence of disease progression or death due to any cause, whichever occurs first.	no later than 6 months after the last patient is enrolled in a cohort
Progression-free survival	Defined as the time from the date of first study drug infusion to the first objective evidence of disease progression or death due to any cause, whichever occurs first.	no later than 6 months after the last patient is enrolled in a cohort
Time to response (for responders)	Defined as the time from the date of first study drug infusion to the first objective evidence of CR or PR as assessed by the IRC.	no later than 6 months after the last patient is enrolled in a cohort
Overall survival	Defined as the time from the date of first study drug infusion to death due to any cause.	no later than 6 months after the last patient is enrolled in a cohort
Composite of safety	Safety will be evaluated by incidence and severity of adverse events, including serious adverse events and incidence of permanent treatment discontinuation due to adverse events.	no later than 6 months after the last patient is enrolled in a cohort

Collaborators and Investigators

• Sponsor: Medivation, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimate): January 13, 2016

Study Record Updates

• Last Update Posted (Estimate): November 25, 2016
• Last Update Submitted That Met QC Criteria: November 22, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: MDV9300-01