Phase 2 N=92 Treatment

Study of Nivolumab in Subjects With Relapsed or Refractory Follicular Lymphoma (FL) (CheckMate 140)

Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT02038946 ↗

Enrolled (actual)

Serious AEs

50.0%

Results posted

Jun 2018

Primary outcome: Primary: Overall Response Rate (ORR) as Determined by IRRC — 4.3 Percentage 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: May 2017

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	—

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.

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

View full record on ClinicalTrials.gov →

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.