Phase 2
Completed N=92
Study of Nivolumab in Subjects With Relapsed or Refractory Follicular Lymphoma (FL) (CheckMate 140)
Source: ClinicalTrials.gov NCT02038946 ↗Enrolled (actual)
92
Serious AEs
50.0%
Results posted
Jun 2018
Primary outcomePrimary: Overall Response Rate (ORR) as Determined by IRRC — 4.3 Percentage of participants
Summary
The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating agent.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) as Determined by IRRC |
4.3 | — |
| SECONDARY Duration of Response (DOR) Based on IRRC Assessments |
10.94 | — |
| SECONDARY Complete Remission Rate (CRR) Based on IRRC Assessment |
1.1 | — |
| SECONDARY Partial Remission (PR) Rate Based on IRRC Assessment |
3.3 | — |
| SECONDARY Progression Free Survival (PFS) Based on IRRC Assessment |
2.20 | — |
| SECONDARY Overall Response Rate (ORR) Based on Investigator Assessments |
10.9 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Grade 1, 2, or 3a FL without pathologic evidence of transformation
- Male and female, ages 18 and above, with relapsed or refractory FL lymphoma after > or =2 prior treatment lines; each of the 2 prior treatment lines must include at least CD20 antibody and/or an alkylating agent
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
Exclusion Criteria
- Known central nervous system lymphoma
- History of interstitial lung disease
- Subjects with active, known or suspected autoimmune disease
- Prior allogeneic stem cell transplant
- Prior autologous stem cell transplant ≤12 weeks prior to first dose of study drug
Data sourced from ClinicalTrials.gov (NCT02038946). 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. Informational only — not medical advice.