NCT03245021

Nivolumab Plus Rituximab in First-line Follicular Lymphoma gr 1-3A

First-line Treatment for Grade 1-3A Follicular Lymphoma Using Opdivo (Nivolumab) Plus Rituximab: The 1st FLOR Study

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Dr. Eliza Hawkes · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Firstline treatment for grade 13a Follicular Lymphoma using Opdivo (nivolumab) plus Rituximab: The 1st FLOR trial

Detailed description

This study will involve participants with a condition called Follicular NonHodgkin Lymphoma (Follicular Lymphoma). The main purpose of this study is to see if it is safe to give drug Nivolumab before and in combination with drug Rituximab and to see how effective Nivolumab is in patients who have had no previous drug treatment for their lymphoma. In particular, we will be monitoring for any specific side effects which may be increased by adding Nivolumab to Rituximab treatment, including monitoring of the immune system. Participants will be reviewed at baseline and prior to each cycle of treatment for toxicity, scans will be performed at baseline, after 4 cycles of nivolumab, after 8 cycles of nivolumab +/rituximab and at 6 months post induction treatment phase and following completion of treatment, participants will be followed up for a total of 5 years (every 3 months for 2 years, every 6 months for 3 years). In participants with relapsed disease, these will be followed for survival every 3 months.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Opdivo	All patients will receive: Nivolumab 240mg IV q2-weekly for four cycles Patients in complete remission (CR): Nivolumab 240mg IV q2-weekly for four further cycles (8 in total) Patients with partial response (PR), stable disease (SD), asymptomatic or minor progressive disease (PD) post 4cycles receive: Nivolumab 240mg IV plus rituximab 375mg/m2 IV q2-weekly for four cycles Patients in CR: Nivolumab 240mg IV q2-weekly for four further cycles (8 in total) Patients with PR, SD, asymptomatic or minor PD post 4 cycles receive: Nivolumab 240mg IV plus rituximab 375mg/m2 IV q2-weekly for four cycles

Timeline

• Start date: 2017-09-07
• Primary completion: 2022-05-11
• Completion: 2027-06-01
• First posted: 2017-08-10
• Last updated: 2024-07-30

Locations

5 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study