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

Diffuse Large B-Cell Lymphoma Clinical Trial

Official title:

A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma (Previously Grade 1-3a) When Administered in the Outpatient Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05451810
• Other study ID #: M23-362
• Status: Recruiting
• Phase: Phase 2
• Start date: August 17, 2022
• Est. completion date: May 1, 2029

Study information

• Verified date: June 2024
• Source: Genmab
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Classic Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the safety of epcoritamab in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL) who have received at least 1 prior line of systemic antilymphoma therapy including at least 1 anti-CD20 monoclonal antibody-containing therapy or R/R classic follicular lymphoma (cFL). Adverse events will be assessed. Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and R/R cFL. Study doctors will assess participants in a monotherapy treatment arm of epcoritamab. Participants will receive escalating doses of epcoritamab, until full dose is achieved. Approximately 184 adult participants with R/R DLBCL and R/R cFL will be enrolled in the study in approximately 80 sites in the United States of America. Participants will receive escalating doses of subcutaneous epcoritamab, until full dose is achieved, in 28-day cycles. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: May 1, 2029
• Est. primary completion date: August 29, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) or R/R Classic Follicular Lymphoma (cFL), with documented CD20+ mature B-cell neoplasm according to World Health Organization (WHO) classification 2016 or WHO classification

2008 based on representative and most recent pathology report:

• Can include participants with "double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Other double-/triple-hit lymphomas are not eligible.
• Relapsed or refractory disease and previously treated with at least 1 prior systemic anti-lymphoma therapy for DLBCL and 2 prior systemic antineoplastic therapies for cFL including at least 1 anti-CD20 monoclonal antibody-containing therapy
• Has at least one target lesion defined as:
• = 1 measurable nodal lesion (long axis > 1.5 cm and short axis > 1.0 cm) and/or = 1 measurable extranodal lesion (long axis > 1.0 cm) on CT (or MRI) AND
• FDG PET scan demonstrating positive lesion(s) compatible with CT (or MRI) defined anatomical tumor sites.
• Must have Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
• Adequate organ function.

Exclusion Criteria:

• Central nervous system (CNS) involvement by lymphoma.
• Uncontrolled Human Immunodeficiency Virus (HIV) infection. HIV viral load that is undetectable and controlled with medication for at least 1 year prior to enrollment is allowed. Note: If subject has no history of HIV infection, HIV testing does not need to be conducted at screening unless it is required per local guidelines or institutional standards.

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Follicular
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Epcoritamab
Subcutaneous Injection (SC)

Locations

Country	Name	City	State
Puerto Rico	Pan American Center for Oncology Trials, LLC /ID# 254952	Rio Piedras
Puerto Rico	Auxilio Mutuo Cancer Center /ID# 254953	San Juan
United States	University of New Mexico /ID# 252434	Albuquerque	New Mexico
United States	Lehigh Valley Hospital-Cedar Crest /ID# 244984	Allentown	Pennsylvania
United States	Texas Oncology - Austin Midtown /ID# 247656	Austin	Texas
United States	Our Lady of the Lake Regional Medical Center /ID# 255008	Baton Rouge	Louisiana
United States	American Oncology Partners of Maryland /ID# 244968	Bethesda	Maryland
United States	Beverly Hills Cancer Center /ID# 255327	Beverly Hills	California
United States	Beth Israel Deaconess Medical Center /ID# 248651	Boston	Massachusetts
United States	Massachusetts General Hospital /ID# 245239	Boston	Massachusetts
United States	Tufts Medical Center /ID# 246074	Boston	Massachusetts
United States	Rocky Mountain Cancer Centers - Boulder /ID# 247653	Boulder	Colorado
United States	St. Luke's Hospital - Chesterfield /ID# 247815	Chesterfield	Missouri
United States	University of Illinois at Chicago /ID# 245038	Chicago	Illinois
United States	Oncology Hematology Care, Inc. /ID# 246182	Cincinnati	Ohio
United States	Maryland Oncology Hematology /ID# 254192	Columbia	Maryland
United States	University of Texas Southwestern Medical Center /ID# 244552	Dallas	Texas
United States	Mission Cancer and Blood /ID# 258227	Des Moines	Iowa
United States	Willamette Valley Cancer Institute and Research Center /ID# 246410	Eugene	Oregon
United States	Parkview Comprehensive Cancer Center /ID# 244545	Fort Wayne	Indiana
United States	Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133	Fountain Valley	California
United States	Virginia Cancer Specialists - Gainesville /ID# 248760	Gainesville	Virginia
United States	Cancer & Hematology Centers of Western Michigan - East /ID# 244985	Grand Rapids	Michigan
United States	East Carolina University - Brody School of Medicine /ID# 248989	Greenville	North Carolina
United States	Prisma Health /ID# 247654	Greenville	South Carolina
United States	Hattiesburg Clinic /ID# 244980	Hattiesburg	Mississippi
United States	Penn State Milton S. Hershey Medical Center /ID# 244979	Hershey	Pennsylvania
United States	Indiana Blood & Marrow Transpl /ID# 244971	Indianapolis	Indiana
United States	Dartmouth-Hitchcock Medical Center /ID# 245003	Lebanon	New Hampshire
United States	University of Arkansas for Medical Sciences /ID# 244562	Little Rock	Arkansas
United States	University of California, Los Angeles /ID# 244573	Los Angeles	California
United States	The West Clinic /ID# 245004	Memphis	Tennessee
United States	Mount Sinai Medical Center-Miami Beach /ID# 249045	Miami Beach	Florida
United States	Morristown Medical Center /ID# 244973	Morristown	New Jersey
United States	Stony Brook University Medical Center /ID# 244631	New York	New York
United States	Illinois Cancer Specialists /ID# 247655	Niles	Illinois
United States	University of Oklahoma, Stephenson Cancer Center /ID# 244568	Oklahoma City	Oklahoma
United States	Memorial Hospital West /ID# 248432	Pembroke Pines	Florida
United States	UPMC Hillman Cancer Ctr /ID# 244571	Pittsburgh	Pennsylvania
United States	New York Cancer and Blood Specialists /ID# 259016	Port Jefferson Station	New York
United States	Blue Ridge Cancer Center /ID# 260597	Roanoke	Virginia
United States	Oregon Oncology Specialists in Salem /ID# 260570	Salem	Oregon
United States	Texas Oncology - San Antonio Medical Center /ID# 247658	San Antonio	Texas
United States	Highlands Oncology Group, PA /ID# 245002	Springdale	Arkansas
United States	Bennett Cancer Center - Stamford Hospital /ID# 244530	Stamford	Connecticut
United States	Northwest Medical Specialties - Tacoma /ID# 245045	Tacoma	Washington
United States	Toledo Clinic Cancer Center - Main /ID# 246852	Toledo	Ohio
United States	Texas Oncology - Northeast Texas /ID# 247657	Tyler	Texas
United States	MedStar Washington Hospital Center /ID# 246068	Washington	District of Columbia
United States	Reading Hospital; McGlinn Cancer Institute /ID# 259181	West Reading	Pennsylvania
United States	Cleveland Clinic Florida /ID# 244532	Weston	Florida
United States	Wake Forest Univ HS /ID# 245005	Winston-Salem	North Carolina
United States	Trinity Health St. Joseph Mercy Ann Arbor /ID# 244547	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Genmab	AbbVie

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Experiencing Grade 3 or Higher Cytokine Release Syndrome (CRS) Events	Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity.	Up to 3 Months
Primary	Percentage of Participants Experiencing Grade 3 or Higher Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events	ICANS events will be graded using ASTCT, with a higher grade indicating higher severity.	Up to 3 Months
Primary	Percentage of Participants Experiencing Grade 3 or Higher Neurotoxicity (Ntox) Events	Ntox is defined as the percentage of participants who developed at least 1 Grade 3 or higher Ntox since the initiation of epcoritamab treatment.	Up to 3 Months
Secondary	Best Overall Response (BOR) Determined by Lugano 2014 Criteria Per Investigator Assessment	BOR is defined as the percentage of participants who achieved best overall response of complete response (CR) or partial response (PR) determined by Lugano 2014 criteria as assessed by investigators.	Up to 3 Months
Secondary	CR Determined by Lugano 2014 Criteria Per Investigator Assessment	Complete response is defined as the percentage of participants who achieved best overall response of CR determined by Lugano 2014 criteria as assessed by investigator.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Incidence of Treatment-Emergent Adverse Events (TEAEs) by Severity Level	Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Severity of TEAEs by Severity Level	Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Incidence of Serious Adverse Events (SAEs) by Severity Level	A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Severity of SAEs by Severity Level	A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Median Time to Onset of CRS of Grade 3 or Higher	Median time to onset of CRS of Grade 3 or higher.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Median Time to Resolution of CRS of Grade 3 or Higher	Median time to resolution of CRS of Grade 3 or higher.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Median Time to Onset of ICANS of Grade 3 or Higher	Median time to onset of ICANS of Grade 3 or higher.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Median Time to Resolution of ICANS of Grade 3 or Higher	Median time to resolution of ICANS of Grade 3 or higher.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Median Time to Onset of Ntox of Grade 3 or Higher	Median time to onset of Ntox of Grade 3 or higher.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Median Time to Resolution of Ntox of Grade 3 or Higher	Median time to resolution of Ntox of Grade 3 or higher.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Percentage of Participants Experiencing Any Adverse Events (AE)s	An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of CRS After the First Full Dose of Epcoritamab	Percentage of participants receiving various interventions for the management of CRS after the first full dose of epcoritamab.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of ICANS After the First Full Dose of Epcoritamab	Percentage of participants receiving various interventions for the management of ICANS after the first full dose of epcoritamab.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of Ntox After the First Full Dose of Epcoritamab	Percentage of participants receiving various interventions for the management of Ntox after the first full dose of epcoritamab.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Duration of response (DOR)	Duration of response is defined for participants who achieved BOR of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Progression-free survival (PFS)	Progression-free survival is defined as the time in months from the first dose of study drug to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Overall survival (OS)	Overall survival is defined for as the time in months from first dose of epcoritamab to death from any cause.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Time-to-response (TTR)	Time to response is defined for participants who achieved BOR of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by investigator, as the time in months from first dose of study drug to initial CR/PR.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Duration of CR (DOCR)	The duration of complete response is defined for participants who achieved BOR of CR (Complete Responders), as the duration from the first CR response to the earliest date of disease progression determined per Lugano 2014 criteria, as assessed by the investigator, or death, whichever occurs first.	Up to 3 Months
Secondary	Diversity Enriched Cohort: Time to Next Treatment	Time to next treatment is defined as the time from the date of the first dose of study drug to the start of new non-protocol-specified treatment or death from any cause.	Up to 3 Months

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