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

NCT03245021 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-07-30

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Eliza Hawkes, MD · Austin Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-07
Primary Completion
2022-05-11
Completion
2027-06-30
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03245021 on ClinicalTrials.gov