Phase 2
N=121
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)
Lymphoma. Non-Hodgkin
Bottom Line
View on ClinicalTrials.gov: NCT02038933 ↗Enrolled (actual)
121
Serious AEs
68.6%
Results posted
May 2017
Primary outcome: Primary: Objective Response Rate (ORR) Per Independent Radiologic Review Committee (IRRC) Assessment — 10.3; 2.9 Percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Per Independent Radiologic Review Committee (IRRC) Assessment |
10.3; 2.9 | — |
| SECONDARY Duration of Response (DOR) |
11.43; 8.34 | — |
| SECONDARY Complete Remission Rate |
3.4; 0 | — |
| SECONDARY Duration of Complete Remission |
NA | — |
| SECONDARY Partial Remission Rate |
6.9; 2.9 | — |
| SECONDARY Duration of Partial Remission |
6.64; 8.34 | — |
| SECONDARY Progression Free Survival |
1.87; 1.41 | — |
| SECONDARY Objective Response Rate (ORR) Per Investigator Assessment |
19.5; 2.9 | — |
Summary
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
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Confirmation of relapsed or refractory DLBCL or transformed lymphoma (TL)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 -1
- At least one lesion that measures >1.5 cm
- Prior therapy and screening lab criteria must be met
- Appropriate contraceptive measures must be taken
Exclusion Criteria
- Known central nervous system (CNS) lymphoma
- History of interstitial lung disease, prior malignancy, active autoimmune disease, positive test for hepatitis B or hepatitis C virus
- Prior allogeneic stem cell transplant (SCT), chest radiation ≤ 24 weeks from study drug, ≥1000 mg of Carmustine Bis-chloroethylnitrosourea (BCNU) as part of pre-transplant conditioning regimen, prior treatment with drug targeting T-cell costimulation or immune checkpoint pathways
- Women who are breastfeeding or pregnant
Data sourced from ClinicalTrials.gov (NCT02038933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.