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

NCT05788081 | Active Not Recruiting Phase 2

• 1 other identifier: IM048-1036
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Follicular Lymphoma Stage II; Follicular Lymphoma Stage III; Follicular Lymphoma Stage IV

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who achieve a complete metabolic response in the absence of prohibitive toxicity with induction rituximab, golcadomide with or without nivolumab comprising 8 cycles of therapy with each cycle delivered every 4 weeks.

  Metabolic response as assessed by PET/CT and defined by Lugano criteria; toxicities as defined by CTCAE v5

  Consent to 8 weeks after last induction treatment (maximum 44 weeks)

Secondary Outcomes (4)

• To assess overall toxicity

  Day 1 to 30 days after the end of maintenance phase (up to maximum 32 months)

• To assess time to treatment failure

  Day 1 end of follow up period (up to a maximum of 5 years)

• Progression free survival

  Day 1 end of follow up period (up to a maximum of 5 years)

• Overall survival

  From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Study Arms (2)

Arm A- Golcadomide + Rituximab

EXPERIMENTAL

Rituximab 375mg/m2 IV infusion Q4W + golcadomide 0.4mg po D1-D14 of each cycle for 8 cycles, followed by Rituximab 375mg/m2 IV infusion Q12W in participants with CR/PR at end of induction

Drug: golcadomide; Drug: Rituximab

Arm B- Nivolumab + golcadomide + Rituximab

EXPERIMENTAL

Nivolumab 480mg IV infusion Q4W, Rituximab 375mg/m2 IV infusion Q4W and golcadomide 0.4mg po D1-D14 of each cycle for 8 cycles, followed by Rituximab 375mg/m2 IV infusion Q12W in participants with CR/PR at end of induction

Drug: golcadomide; Drug: Nivolumab 10 MG/ML; Drug: Rituximab

Interventions

golcadomide DRUG

BMS-986369 is an orally administered Cereblon-modulating compound

Also known as: BMS-986369, CC-99282

Arm A- Golcadomide + Rituximab; Arm B- Nivolumab + golcadomide + Rituximab

Nivolumab 10 MG/ML DRUG

Nivolumab is a fully humanised IgG4 blocking monoclonal antibody against PD-1.

Also known as: Opdivo

Arm B- Nivolumab + golcadomide + Rituximab

Rituximab DRUG

Rituximab is a chimeric anti-CD20 antibody containing human IgG lambda and kappa constant regions with murine variable regions

Also known as: Mabthera

Arm A- Golcadomide + Rituximab; Arm B- Nivolumab + golcadomide + Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+ years.
• Histologically proven CD20 positive Follicular non Hodgkin lymphoma (FL) grades 1-3A (i.e. classical follicular lymphoma according to the current World Health Organization classification).3
• No previous chemotherapy, or other investigational drug for this indication apart from focal radiotherapy.
• Stage II-IV disease (Ann Arbor criteria).
• Eastern Collaborative Oncology Group (ECOG) performance status 0 to 1 unless attributable to lymphoma, in which case patients of performance status 2 are also eligible.
• Measurable FDG avid disease on baseline PET/CT scan.
• Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to:
• a. Any nodal or extranodal tumour mass \>7cm AND/OR multiple extranodal disease sites b. Involvement of at least 3 sites each with diameter \>3cm c. Symptomatic splenic enlargement d. Organ involvement/compression e. Ascites or pleural effusion f. Lactate Dehydrogenase (LDH) elevated g. Presence of systemic symptoms h. Disease progression in preceding 3 months i. Evidence of marrow infiltration with marrow compromise. (e.g., Hb, WCC or plt count below lower limit of institutional normal range).
• h) Adequate bone marrow function including:
• Haemoglobin \>8.0 g/dL
• White cell count (WCC) ≥2000/μL
• Neutrophils \>1.5 x 109/L
• Platelets \>75 x 109/L at the time of study entry, unless attributed to bone marrow infiltration by lymphoma.
• i) Adequate renal function with serum creatinine ≤1.5 x ULN or creatinine clearance (CrCl) ≥ 60mL/min (using Cockcroft-Gault formula, 24hr urine collection or eGFR).
• Female CrCl = (140 - age in years) x weight (kg) x 0.85 72 x serum creatinine (mg/dL)

You may not qualify if:

• Follicular large B-cell Lymphoma (Grade 3B) transformed follicular lymphoma, other indolent lymphomas.
• Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
• Central nervous system, meningeal involvement or spinal cord compression by lymphoma.
• Patients with active, known or suspected autoimmune disease. Patients with well controlled type I diabetes mellitus, coeliac disease, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, vitiligo or psoriasis not requiring systemic treatment, or other conditions not expected to recur in the absence of an external trigger are permitted to enrol.
• Subjects with a condition requiring systemic treatment with either corticosteroids (\>10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement therapy are permitted in the absence of active autoimmune disease.
• Past history of interstitial lung disease.
• Prior organ transplantation or allogeneic bone marrow transplantation.
• Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
• Uncontrolled or severe cardiovascular disease (NYHA class III or IV heart failure; myocardial infarction within the last 6 months of study entry); unstable angina; unstable cardiac arrhythmias; clinically significant pericardial disease.
• Any other serious active disease.
• Any positive test result for hepatitis B or hepatitis C virus during screening indicating acute or chronic infection. Latent hepatitis B with undetectable viral load by PCR is allowable provided appropriate anti-viral prophylaxis is given as per institutional guidelines.
• Any positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
• Any history of severe hypersensitivity reactions to other monoclonal antibodies.
• A history of allergy or intolerance (unacceptable AEs) to study drug components or Polysorbate-80-containing infusions.
• Medical or psychiatric conditions that compromise the patient's ability to give informed consent.

Sponsors & Collaborators

• Olivia Newton-John Cancer Research Institute: lead
• Austin Health: collaborator
• Grampians Health: collaborator
• Fiona Stanley Hospital: collaborator
• Eastern Health: collaborator
• Barwon Health: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (5)

Grampians Health

Ballarat, Victoria, Australia

Location

Eastern Health

Box Hill, Victoria, 3128, Australia

Location

University Hospital Geelong, Barwon Health

Geelong, Victoria, Australia

Location

Austin Health

Heidelberg, Victoria, 3078, Australia

Location

Fiona Stanley Hospital

Perth, Western Australia, Australia

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Nivolumab; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived

Study Officials

• Eliza Hawkes, MBBS

  Austin Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study Design Open label multicentre umbrella Bayesian Optimal Phase II study

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 28, 2023
• Study Start: August 31, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)