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

Phase 2

Withdrawn

• Conditions: Lymphoma, Large B-Cell, Diffuse; Primary Mediastinal Large B-cell Lymphoma; Transformed Indolent Lymphoma
• Interventions: Biological: MDV9300

• Registration Number: NCT02653989
• Lead Sponsor: Medivation, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-12
• Study First Posted: 2016-01-13
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-25
• Study Start: 2016-12
• Primary Completion: 2018-06
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MDV9300	MDV9300	-

Primary Outcome Measures

Name	Time	Method
Best overall response rate	no later than 6 months after the last patient is enrolled in a cohort	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).

Secondary Outcome Measures

Name	Time	Method
Duration of response (for responders)	no later than 6 months after the last patient is enrolled in a cohort	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.
Progression-free survival	no later than 6 months after the last patient is enrolled in a cohort	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.
Time to response (for responders)	no later than 6 months after the last patient is enrolled in a cohort	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.
Overall survival	no later than 6 months after the last patient is enrolled in a cohort	Defined as the time from the date of first study drug infusion to death due to any cause.
Composite of safety	no later than 6 months after the last patient is enrolled in a cohort	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.