| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05578976 | A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) | PHASE3 | ACTIVE NOT_RECRUITING | 900 | — | — | Feb 1, 2023 | Dec 1, 2029 | Jan 22, 2025 | - | — |
| NCT07226752 | A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in China | PHASE3 | ACTIVE NOT_RECRUITING | 72 | — | — | Oct 1, 2022 | Jun 1, 2028 | Mar 2, 2026 | - | — |
| NCT04628494 | A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) | PHASE3 | ACTIVE NOT_RECRUITING | 484 | — | — | Jan 1, 2021 | Apr 1, 2028 | Mar 2, 2026 | - | — |
| NCT06508658 | A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma | PHASE3 | ACTIVE NOT_RECRUITING | 379 | — | — | Aug 13, 2024 | Mar 1, 2028 | Apr 8, 2026 | 176 | United States, Argentina +26 |
| NCT05660967 | Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma | PHASE2 | ACTIVE NOT_RECRUITING | 111 | — | — | Mar 1, 2023 | Jun 1, 2026 | Mar 2, 2026 | - | — |
| NCT05451810 | A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma | PHASE2 | ACTIVE NOT_RECRUITING | 184 | — | — | Aug 17, 2022 | Mar 1, 2027 | Jan 24, 2025 | 72 | United States, Puerto Rico |
| NCT04663347 | Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) | PHASE1 | ACTIVE NOT_RECRUITING | 543 | — | — | Nov 3, 2020 | Sep 30, 2027 | Jun 2, 2026 | 57 | United States, Australia +11 |
PFS is defined as the duration from the date of randomization to the date of disease progression determined per Lugano 2014 criteria as assessed by an independent review committee (IRC), or death, whichever occurs first.
Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity.
ICANS events will be graded using ASTCT, with a higher grade indicating higher severity.
Ntox is defined as the percentage of participants who developed at least 1 Grade 3 or higher Ntox since the initiation of epcoritamab treatment.
DLT events are defined as clinically significant adverse events (AEs) or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications as assessed per Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign. (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria.
| Arm | Type | Description |
|---|---|---|
| Arm A: Epcoritamab Plus Lenalidomide (E-Len) | EXPERIMENTAL | Participants will receive E-Len for up to 12 cycles (each cycle is 28 days). |
| Arm B: Rituximab Plus Gemcitabine and Oxaliplatin (R-GemOx) | EXPERIMENTAL | Participants will receive R-GemOx for up to 4 cycles (each cycle is 28 days) |
| Arm C: Epcoritamab | EXPERIMENTAL | Participants will receive epcoritamab for up to 12 cycles (each cycle is 28 days). |
| Main Cohort: Epcoritamab Diffuse Large B-Cell Lymphoma (DLBCL) | EXPERIMENTAL | Participants with relapsed or refractory (R/R) DLBCL will receive subcutaneous (SC) epcoritamab in 28 day cycles. |
| Main Cohort: Epcoritamab Classic Follicular Lymphoma (cFL) | EXPERIMENTAL | Participants with R/R cFL will receive SC epcoritamab in 28 day cycles. |
| Diversity Enriched Cohort: Epcoritamab DLBCL | EXPERIMENTAL | Participants with R/R DLBCL will receive SC epcoritamab in 28 day cycles. |
| Diversity Enriched Cohort: Epcoritamab cFL | EXPERIMENTAL | Participants with R/R cFL will receive SC epcoritamab in 28 day cycles. |
| Arm 1 - Epcoritamab + R-CHOP | EXPERIMENTAL | In participants with previously untreated DLBCL. |
| Arm 2 - Epcoritamab + R2 | EXPERIMENTAL | In participants with R/R FL. |
| Arm 3 - Epcoritamab + BR | EXPERIMENTAL | In participants with previously untreated FL. |
| Arm 4 - Epcoritamab + R-DHAX/C | EXPERIMENTAL | In participants with R/R DLBCL eligible for ASCT. |
| Arm 5 - Epcoritamab + GemOx | EXPERIMENTAL | In participants with R/R DLBCL ineligible ASCT. |
| Arm 6 - Epcoritamab + R2 | EXPERIMENTAL | In participants with previously untreated FL. |
| Arm 7 - Epcoritamab maintenance | EXPERIMENTAL | In participants with FL who achieved a CR or PR after receiving SOC treatment in 1L or 2L. |
| Arm 8 - Epcoritamab + R mini-CHOP | EXPERIMENTAL | In participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline. |
| Arm 9 - Epcoritamab + Lenalidomide | EXPERIMENTAL | In participants with R/R FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy. |
| Arm 10 - Epcoritamab + R-ICE | EXPERIMENTAL | In participants with R/R DLBCL eligible for ASCT. |
| Name | Type | Description |
|---|---|---|
| Epcoritamab | DRUG | Subcutaneous Injection (SC) |
| Cyclophosphamide | DRUG | Intravenous (IV) Injection |
| Rituximab | DRUG | IV Infusion |
| Vincristine | DRUG | IV Infusion |
| Doxorubicin | DRUG | IV Infusion |
| Prednisone | DRUG | Oral; Tablet |
| Investigator's Choice Chemotherapy | DRUG | Following mandatory pre-medication, participants will be administered intravenously either BR or R-GemOx. |
| Lenalidomide | DRUG | Oral Capsule |
| Oxaliplatin | DRUG | IV Infusion |
| Gemcitabine | DRUG | IV Infusion |
| rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone | DRUG | 6 cycles (21-day cycles) |
| rituximab and lenalidomide | DRUG | rituximab 6 cycles and lenalidomide 12 cycles (28-day cycles) |
| rituximab and bendamustine | DRUG | 6 cycles (28-day cycles) |
| rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin | DRUG | 3 cycles (21-day cycles) |
| gemcitabine and oxaliplatin | DRUG | 4 cycles (28-day cycles) |
| rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone | DRUG | 6 cycles (21-day cycles) |
| rituximab, ifosfamide, carboplatin, and etoposide phosphate | DRUG | 3 cycles (21-day cycles) |
Inclusion Criteria: * Eastern Cooperative Oncology Group Performance status score of 0 to 2. * Histologically confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) and documented in the most recent and representative pathology report, inclusive of the following according to the World Health Organiz...