Informations générales (source: ClinicalTrials.gov)
A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) (EPCORE™ NHL-2)
Interventional
Phase 1/Phase 2
Genmab (Voir sur ClinicalTrials)
novembre 2020
septembre 2028
19 juillet 2025
The purpose of this trial is to measure the safety and effectiveness of epcoritamab
(EPKINLY™), either by itself or together with other therapies, when treating participants
with B-cell non-Hodgkin Lymphoma (B-NHL). The aim of the first part of the trial is to
identify the most appropriate dose of epcoritamab, and the aim of the second part of the
trial is to assess the selected epcoritamab dose in a larger group of participants with
B-NHL. All participants in this trial will receive either epcoritamab alone, or
epcoritamab combined with another standard treatment regimen, with a total of 10
different treatment arms being studied.
Trial details include:
- The treatment duration for each participant depends upon which arm of treatment they
are assigned to.
- The visit frequency for each participant depends upon which arm of treatment they
are assigned to, but will be weekly to start for all participants, then will
decrease to either: every 2 weeks, or every 3 weeks, or every 4 weeks, or every 8
weeks.
- All participants will receive active drug; no one will be given placebo.
Participants who receive treatment with epcoritamab will have it injected right under the
skin. Participants will receive a different regimen of epcoritamab depending upon which
arm of treatment they are assigned.
Participants who receive standard treatments will have intravenous (IV) infusions and/or
oral administration of those treatments. Participants will receive a different standard
treatment regimen depending upon which arm of treatment they are assigned.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Hospitalier Lyon Sud - 69495 - Pierre-Bénite - France | Contact (sur clinicalTrials) | ||||
| Hopital Claude Huriez - CHRU Lille - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Hôpital de la Timone - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint-Louis - 75475 - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Key Inclusion Criteria
1. 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
computed tomography (CT) or magnetic resonance imaging (MRI). Applies to all arms
except arm 7.
2. Eastern Cooperative Oncology Group (ECOG) PS score of 0, 1 or 2
3. Acceptable organ function at screening
4. CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy
5. If of childbearing potential participant must practicing a highly effective method
of birth control
6. A man who is sexually active with a woman of childbearing potential must agree to
use a barrier method of birth control
Arm 1:
- Newly diagnosed DLBCL
- DLBCL, not otherwise specified (NOS)
- "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:
- Documented R/R DLBCL and eligible for HDT-ASCT
- DLBCL, NOS
- "Double-hit" or "triple-hit" DLBCL
- FL Grade 3B
Arm 5:
- Documented R/R DLBCL and ineligible for HDT-ASCT
- DLBCL, NOS
- "Double-hit" or "triple-hit" DLBCL
- FL Grade 3B
Arm 6: Newly diagnosed, previously untreated FL grade 1-3A
Arm 7:
- FL Grade 1-3A
- If PR or CR per Lugano criteria following first-line or second-line treatment with
SOC regimen, and last dose of SOC within 6 months prior to enrollment.
Arm 8:
- Newly diagnosed DLBCL who are not fit to receive full-dose anthracycline
- T-cell/histiocyte rich DLBCL
- "Double-hit" or "triple-hit" DLBCL
- FL Grade 3B
Arm 9:
- R/R FL
- Progressed within 24 months of initiating first-line treatment
Arm 10:
- Documented R/R DLBCL and eligible for HDT-ASCT
- DLBCL, NOS
- "Double-hit" or "triple-hit" DLBCL
- FL Grade 3B
Key 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 100 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. 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. Positive tests for hepatitis B virus or hepatitis C virus indicating acute or
chronic infection
8. Known history of seropositivity of human immunodeficiency virus (HIV)
9. Active tuberculosis or history of completed treatment for active tuberculosis within
the past 12 months
10. Neuropathy > grade 1
11. Receiving immunostimulatory agent
12. Prior allogeneic HSCT
13. Current seizure disorder requiring anti-epileptic therapy
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
1. 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
computed tomography (CT) or magnetic resonance imaging (MRI). Applies to all arms
except arm 7.
2. Eastern Cooperative Oncology Group (ECOG) PS score of 0, 1 or 2
3. Acceptable organ function at screening
4. CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy
5. If of childbearing potential participant must practicing a highly effective method
of birth control
6. A man who is sexually active with a woman of childbearing potential must agree to
use a barrier method of birth control
Arm 1:
- Newly diagnosed DLBCL
- DLBCL, not otherwise specified (NOS)
- "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:
- Documented R/R DLBCL and eligible for HDT-ASCT
- DLBCL, NOS
- "Double-hit" or "triple-hit" DLBCL
- FL Grade 3B
Arm 5:
- Documented R/R DLBCL and ineligible for HDT-ASCT
- DLBCL, NOS
- "Double-hit" or "triple-hit" DLBCL
- FL Grade 3B
Arm 6: Newly diagnosed, previously untreated FL grade 1-3A
Arm 7:
- FL Grade 1-3A
- If PR or CR per Lugano criteria following first-line or second-line treatment with
SOC regimen, and last dose of SOC within 6 months prior to enrollment.
Arm 8:
- Newly diagnosed DLBCL who are not fit to receive full-dose anthracycline
- T-cell/histiocyte rich DLBCL
- "Double-hit" or "triple-hit" DLBCL
- FL Grade 3B
Arm 9:
- R/R FL
- Progressed within 24 months of initiating first-line treatment
Arm 10:
- Documented R/R DLBCL and eligible for HDT-ASCT
- DLBCL, NOS
- "Double-hit" or "triple-hit" DLBCL
- FL Grade 3B
Key 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 100 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. 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. Positive tests for hepatitis B virus or hepatitis C virus indicating acute or
chronic infection
8. Known history of seropositivity of human immunodeficiency virus (HIV)
9. Active tuberculosis or history of completed treatment for active tuberculosis within
the past 12 months
10. Neuropathy > grade 1
11. Receiving immunostimulatory agent
12. Prior allogeneic HSCT
13. Current seizure disorder requiring anti-epileptic therapy
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.