Study of Nivolumab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) That Have Either Failed or Are Not Eligible for Autologous Stem Cell Transplant (CheckMate 139)

Conditions

• Lymphoma. Non-Hodgkin

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — DRUG

Study Details

The purpose of this study is to determine whether Nivolumab is effective in the treatment of DLBCL in patients that have failed or are ineligible for ASCT

Key Dates

Start date

Mar 5, 2014

Status verified

Oct 2021

Primary completion

Apr 8, 2016

Completion

Oct 8, 2020

Study Design

Enrollment

121 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Nivolumab (3 mg/kg)
  Nivolumab 3 mg/kg solution intravenously every 2 weeks until progression or unacceptable toxicity

Primary Outcome Measure

Objective Response Rate (ORR) Per Independent Radiologic Review Committee (IRRC) Assessment [ Time Frame: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assesed up to April 2016, approximately 25 months) ]

Locations (10)

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