Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma
Public ClinicalTrials.gov record NCT05409066. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m\^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study identification
- NCT ID
- NCT05409066
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 549 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 19, 2022
- Primary completion
- Nov 30, 2029
- Completion
- Nov 30, 2029
- Last update posted
- Jul 7, 2026
2022 – 2029
United States locations
- U.S. sites
- 31
- U.S. states
- 20
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Arizona Cancer Center - North Campus /ID# 228862 | Tucson | Arizona | 85719 | — |
| University of Arkansas for Medical Sciences /ID# 227198 | Little Rock | Arkansas | 72205 | — |
| Alta Bates Summit Medical Center for Research /ID# 229428 | Berkeley | California | 94705 | — |
| Beverly Hills Cancer Center /ID# 231535 | Beverly Hills | California | 90211 | — |
| Long Beach Memorial Medical Ct /ID# 228997 | Long Beach | California | 90806-1701 | — |
| University of Southern California /ID# 227195 | Los Angeles | California | 90033 | — |
| Valkyrie Clinical Trials /ID# 268502 | Los Angeles | California | 90067 | — |
| Duplicate_Emory University /ID# 227299 | Atlanta | Georgia | 30322-1013 | — |
| Hawaii Cancer Care - Waterfront Plaza /ID# 262448 | Honolulu | Hawaii | 96813-4920 | — |
| Northwestern University Feinberg School of Medicine /ID# 227248 | Chicago | Illinois | 60611-2927 | — |
| Goshen Center for Cancer Care /ID# 227189 | Goshen | Indiana | 46526 | — |
| Community Health Network, Inc. /ID# 259756 | Indianapolis | Indiana | 46250-2042 | — |
| Our Lady Of The Lake Regional Medical Center /ID# 251393 | Baton Rouge | Louisiana | 70808 | — |
| University of Maryland, Baltimore /ID# 227191 | Baltimore | Maryland | 21201 | — |
| Massachusetts General Hospital /ID# 245233 | Boston | Massachusetts | 02114 | — |
| UMass Memorial Medical Center /ID# 227323 | Worcester | Massachusetts | 01605 | — |
| Henry Ford Hospital /ID# 227250 | Detroit | Michigan | 48202 | — |
| St. Luke's Hospital - Chesterfield /ID# 247817 | Chesterfield | Missouri | 63017 | — |
| Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 251220 | Billings | Montana | 59102 | — |
| Morristown Medical Center /ID# 231427 | Morristown | New Jersey | 07960-6136 | — |
| Roswell Park Cancer Institute /ID# 239128 | Buffalo | New York | 14263 | — |
| NYU Langone Hospital - Long Island /ID# 253343 | Mineola | New York | 11501 | — |
| NYU Laura and Isaac Perlmutter Cancer Center /ID# 227322 | New York | New York | 10016 | — |
| Icahn School of Medicine at Mount Sinai /ID# 227181 | New York | New York | 10029 | — |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 227193 | New York | New York | 10065-6007 | — |
| East Carolina University - Brody School of Medicine /ID# 227192 | Greenville | North Carolina | 27834 | — |
| University of Oklahoma, Stephenson Cancer Center /ID# 227325 | Oklahoma City | Oklahoma | 73104-5418 | — |
| Baylor Sammons Cancer Center /ID# 261584 | Dallas | Texas | 75246 | — |
| Texas Oncology - Northeast Texas /ID# 265890 | Tyler | Texas | 75702 | — |
| Intermountain Healthcare LDS Hospital /ID# 259948 | Salt Lake City | Utah | 84143 | — |
| Virginia Commonwealth University Medical Center Main Hospital /ID# 227211 | Richmond | Virginia | 23219 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 242 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05409066, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 7, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05409066 live on ClinicalTrials.gov.