NCT05788081

Treatment Of Newly-diagnosed Follicular Lymphoma With CELMoD Golcadomide, Rituximab +/- Nivolumab.

Treatment Of Newly-diagnosed Follicular Lymphoma With CELMoD Golcadomide, Rituximab +/- Nivolumab: An Umbrella Bayesian Optimal Phase II Study.

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Olivia Newton-John Cancer Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

First line treatment with combination rituximab and golcadomide with, or without nivolumab, in patients in previously untreated Follicular Lymphoma

Detailed description

This study will involve participants with a condition called Follicular Non Hodgkin Lymphoma (Follicular Lymphoma). The main purpose of this study is to see if it is safe to give an induction schedule of the drug golcadomide, in combination with Rituximab +/- Nivolumab, and to see how effective this combination 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 golcadomide to Rituximab treatment +/- Nivolumab for 8 cycles (28 days per cycle), with up to 2 years of maintenance treatment of rituximab in eligible patients following induction. Participants will be reviewed at baseline and prior to each cycle of treatment for toxicity, scans will be performed at baseline, after 2 and 5 cycles of induction treatment, and every 8 weeks during maintenance phase. Following completion of treatment, participants will be followed up for a total of 3 years (every 6 months). In participants with relapsed disease, these will be followed for survival every 3 months.

Conditions

• Follicular Lymphoma Stage II
• Follicular Lymphoma Stage III
• Follicular Lymphoma Stage IV

Interventions

Type	Name	Description
DRUG	golcadomide	BMS-986369 is an orally administered Cereblon-modulating compound
DRUG	Nivolumab 10 MG/ML	Nivolumab is a fully humanised IgG4 blocking monoclonal antibody against PD-1.
DRUG	Rituximab	Rituximab is a chimeric anti-CD20 antibody containing human IgG lambda and kappa constant regions with murine variable regions

Timeline

• Start date: 2023-08-31
• Primary completion: 2027-01-01
• Completion: 2027-06-01
• First posted: 2023-03-28
• Last updated: 2025-08-20

Locations

5 sites across 1 country: Australia