Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma

Phase 1

• Conditions: B-cell Non-Hodgkin LymphomaDiffuse large B-cell lymphomaNon-Hodgkin lymphomaFollicular lymphoma; MedDRA version: 20.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-000845-15-BE
• Lead Sponsor: Genmab A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-23
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 396

Inclusion Criteria

1. Subject must sign an ICF
2. At least 18 years of age
3. Measurable disease defined as =1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or =1 measurable extra-nodal lesion (long axis >1.0 cm) on CT or MRI
4. ECOG PS score of 0, 1 or 2
5. Acceptable organ function at screening
6. CD20-positive NHL at most recent representative tumor biopsy
7. If of childbearing potential subject must practicing a highly effective method of birth control
8. A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control
9. Life expectancy >2 months with SOC treatment.

Arm 1: One of these confirmed histologies:
- DLBCL, NOS
- T-cell/histiocyte rich DLBCL
- double-hit or triple-hit DLBCL
- FL Grade 3B
Arm 2: R/R FL
Arm 3: Newly diagnosed, previously untreated FL grade 1-3A
Arm 4: One of these confirmed histologies and eligible for HDT-ASCT
- DLBCL, NOS
- T-cell/histiocyte rich DLBCL
- double-hit or triple-hit DLBCL
- FL Grade 3B
Arm 5: One of these confirmed histologies and ineligible for HDT-ASCT
- DLBCL, NOS
- T-cell/histiocyte rich DLBCL
- double-hit or triple-hit DLBCL
- FL Grade 3B
Arm 6: previously untreated CD20+ FL
Arm 7: FL and in CR or PR per Lugano criteria following first-line or second-line treatment with SOC regiment and last dose of SOC within 6 months prior to enrollment
Arm 8: One of these confirmed histologies:
- DLBCL, NOS
- T-cell/histiocyte rich DLBCL
- double-hit” or triple-hit” DLBCL
-FL Grade 3B
For Arm8, subjects must be ineligible to receive full-dose anthracycline (as part of R-CHOP) per eligibility criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 198
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 198

Exclusion Criteria

1. Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
2. Any prior treatment with a bispecific antibody targeting CD3 and CD20.
3. Treatment with CAR-T therapy within 30 days prior to first dose of epcoritamab
4. Clinically significant cardiovascular disease
5. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
6. Primary CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture
7. Active HBV or HBC (DNA PCR positive infection)
8. Known history of seropositivity for human immunodeficiency virus (HIV)
9. Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months
10. Subject has current seizure disorder requiring anti-epileptic therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified