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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 Previously Untreated Follicular Lymphoma
NotablePrimary endpoints revised (2)Enrollment target: 1080 to 1095 · Study sites: 196 to 220 · Secondary endpoints: 53 to 94 · 2 morev16Show 5 more changesShow less
MinorStudy sites: 171 to 195Primary and study completion dates: May 18, 2037 to Nov 2037v14Show 1 more changeShow less
Primary and study completion dates: May 18, 2037 to Nov 2037
MinorStudy sites: 146 to 171v13
NotablePrimary completion date: Jan 17, 2030 to May 18, 2037Study sites: 119 to 146v12Show 1 more changeShow less
Study sites: 119 to 146
MinorStudy sites: 86 to 119v11
NotablePrimary completion date: May 18, 2037 to Jan 17, 2030Study sites: 57 to 86v10Show 1 more changeShow less
Study sites: 57 to 86
MinorStudy sites: 38 to 57v9
NotableLead sponsor: AbbVie to GenmabPrimary completion date: Oct 5, 2028 to May 18, 2037 · Primary endpoints: 1 to 2 · Enrollment target: 900 to 1080 · 5 morev8Show 8 more changesShow less
Primary completion date: Oct 5, 2028 to May 18, 2037
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 5 · Start date changed from estimate of Jan 25, 2024 to Feb 5, 2024v3Show 2 more changesShow less
Study sites: 0 to 5
Start date changed from estimate of Jan 25, 2024 to Feb 5, 2024
MinorStart date: Mar 9, 2026 to Jan 25, 2024v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 previously untreated 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 5 groups, called treatment arms. Each group receives a different treatment. Around 1095 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world.
Participants will receive R2 (intravenous \[IV\] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab. Participants may also receive investigator's choice chemoimmunotherapy (CIT): IV infusion of obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV injections of vincristine, oral tablets of prednisone (CHOP) \[G-CHOP\]/ R-CHOP or G and IV infusion of bendamustine (Benda) \[G-Benda\]/R-Benda. The total treatment duration will be 120 weeks for all arms except A2, which is 24 weeks of treatment.
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.