This study has been transitioned to CTIS with ID 2023-505347-38-00 check the CTIS register for the current data. The primary objectives of the study are to characterize the safety and toxicity profiles of epcoritamab when co-administered with anti-…
ID
Source
Brief title
Condition
- Lymphomas non-Hodgkin's B-cell
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is dose limiting toxicities (DLTs) of epcoritamab in
combination with anti-neoplastic agents.
Secondary outcome
• Overall Response Rate (ORR) by Lugano 2014 criteria (Appendix E) as assessed
by investigator for epcoritamab in combination with other anti-neoplastic
agents.
• Anti-lymphoma activity of epcoritamab in combination with other
anti-neoplastic agents:
-Duration of response (DOR) determined per Lugano 2014 criteria as
assessed by investigator
-Progression free survival (PFS) determined per Lugano 2014 criteria
as assessed by investigator
-Complete Response (CR) rate determined per Lugano 2014 criteria as
assessed by investigator
-Time to response (TTR) determined per Lugano 2014 criteria as
assessed by investigator
-Time to next anti-lymphoma therapy (TTNT)
-Rate of Minimal Residual Disease (MRD) negativity
-Overall survival (OS)
Background summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a
white blood cell responsible for fighting infections). The purpose of this
study is to assess the safety and tolerability of epcoritamab in combination
with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma
(NHL). Adverse events and change in disease activity will be assessed.
Study objective
This study has been transitioned to CTIS with ID 2023-505347-38-00 check the CTIS register for the current data.
The primary objectives of the study are to characterize the safety and toxicity
profiles of epcoritamab when co-administered with anti-neoplastic agents in
subjects with B-cell NHL and to determine the recommended dose for further
investigation of epcoritamab when co- administered with anti-neoplastic agents
in subjects with B-cell NHL.
Study design
Open-Label; Dose-escalation and Dose-expansion Study
Intervention
In both the dose escalation and dose expansion arms participants will receive
subcutaneous (SC) epcoritamab in 28-day or 21 day cycles dependent on the arm
in combination with the anti-neoplastic agents described below:
1: Oral lenalidomide in participants with relapsed/refractory(R/R) diffuse
large B-cell lymphoma (DLBCL);
2: Oral ibrutinib and oral lenalidomide in participants with with R/R DLBCL;
3: Intravenous (IV) polatuzumab vedotin, IVrituximab, IV cyclophosphamide, IV
doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP)
inparticipants with newly diagnosed treatment-naïve DLBCL;
4: Oral CC-99282 in participants with R/R DLBCL;
5: OralCC-99282 in participants with R/R follicular lymphoma (FL);
6A: Oral ibrutinib in participants with R/R mantle cell lymphoma (MCL);
6B: Oral ibrutinib, and oral venetoclax in participants with R/R MCL;
7: Oral ibrutinib,and oral venetoclax in participants with newly diagnosed
treatment-naïve MCL.
Study burden and risks
There may be higher treatment burden for participants in this trial compared to
their standard of care. Participants will attend regular visits during the
study at an approved institution (hospital or clinic). The effect of the
treatment will be frequently checked by medical assessments, blood tests,
questionnaires and side effects.
Knollstrasse 50
Ludwigshafen 67061
DE
Knollstrasse 50
Ludwigshafen 67061
DE
Listed location countries
Age
Inclusion criteria
1. Adult male or female, at least 18 years old 2. Diagnosis of DLBCL with
histologically confirmed CD20+ disease, inclusive of the following according to
WHO 2016 classification and documented in pathology report: • DLBCL, not
otherwise specified (NOS) • High-grade B cell lymphoma with MYC and BCL-2
and/or BCL-6 translocations per WHO 2016 (*double-hit* or *triple-hit*) Note:
High-grade B-cell lymphomas NOS or other double-/triple-hit lymphomas (with
histologies not consistent with DLBCL) are not eligible • Follicular lymphoma
Grade 3B 3. Subject must have Eastern Cooperative Oncology Group (ECOG)
performance status 0 - 2 4. Subject must have 1 or more measurable disease
sites: • A positron emission tomography/computed tomography (PET/CT) scan
demonstrating PET-positive lesion(s) AND • At least 1 measurable nodal lesion
(long axis >= 1.5cm and short axis > 1.0 cm) or >= 1 measurable extra-nodal
lesion (long axis >= 1.0 cm) on CT scan or MRI
Exclusion criteria
1.Diagnosis of High-grade B-cell lymphomas NOS or other double-/triple-hit
lymphomas (with histologies not consistent with DLBCL)
2. Subjects who have had prior treatment with epcoritamab or any other
bispecific antibody targeting CD3 and CD20
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-505347-38-00 |
| EudraCT | EUCTR2021-005725-24-NL |
| ClinicalTrials.gov | NCT05283720 |
| CCMO | NL80499.056.22 |