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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Genmab
Study ID
NCT05409066
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Follicular Lymphoma (FL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epcoritamab — DRUG
    Subcutaneous Injection
  • Rituximab — DRUG
    Intravenous Infusion
  • Lenalidomide — DRUG
    Oral Capsules

Study Details

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.

Key Dates

Start date
Sep 20, 2022
Status verified
Jul 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
549 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Epcoritamab Dose A in Combination With R2
    Participants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
  • Experimental: Epcoritamab Dose B in Combination With R2
    Participants will receive epcoritamab Dose B in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days). Enrollment is closed for this arm.
  • Active Comparator: Lenalidomide and Rituximab (R2)
    Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).

Primary Outcome Measure

Percentage of Participants Achieving Best Overall Response (BOR) [ Time Frame: Up to approximately 5 years ]

Locations (31)

FacilityCityStateZIPSite coordinators
The University of Arizona Cancer Center - North Campus /ID# 228862TucsonArizona85719-
University of Arkansas for Medical Sciences /ID# 227198Little RockArkansas72205-
Alta Bates Summit Medical Center for Research /ID# 229428BerkeleyCalifornia94705-
Beverly Hills Cancer Center /ID# 231535Beverly HillsCalifornia90211-
Long Beach Memorial Medical Ct /ID# 228997Long BeachCalifornia90806-1701-
University of Southern California /ID# 227195Los AngelesCalifornia90033-
Valkyrie Clinical Trials /ID# 268502Los AngelesCalifornia90067-
Duplicate_Emory University /ID# 227299AtlantaGeorgia30322-1013-
Hawaii Cancer Care - Waterfront Plaza /ID# 262448HonoluluHawaii96813-4920-
Northwestern University Feinberg School of Medicine /ID# 227248ChicagoIllinois60611-2927-
Goshen Center for Cancer Care /ID# 227189GoshenIndiana46526-
Community Health Network, Inc. /ID# 259756IndianapolisIndiana46250-2042-
Our Lady Of The Lake Regional Medical Center /ID# 251393Baton RougeLouisiana70808-
University of Maryland, Baltimore /ID# 227191BaltimoreMaryland21201-
Massachusetts General Hospital /ID# 245233BostonMassachusetts02114-
UMass Memorial Medical Center /ID# 227323WorcesterMassachusetts01605-
Henry Ford Hospital /ID# 227250DetroitMichigan48202-
St. Luke's Hospital - Chesterfield /ID# 247817ChesterfieldMissouri63017-
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 251220BillingsMontana59102-
Morristown Medical Center /ID# 231427MorristownNew Jersey07960-6136-
Roswell Park Cancer Institute /ID# 239128BuffaloNew York14263-
NYU Langone Hospital - Long Island /ID# 253343MineolaNew York11501-
Icahn School of Medicine at Mount Sinai /ID# 227181New YorkNew York10029-
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 227193New YorkNew York10065-6007-
NYU Laura and Isaac Perlmutter Cancer Center /ID# 227322New YorkNew York10016-
East Carolina University - Brody School of Medicine /ID# 227192GreenvilleNorth Carolina27834-
University of Oklahoma, Stephenson Cancer Center /ID# 227325Oklahoma CityOklahoma73104-5418-
Baylor Sammons Cancer Center /ID# 261584DallasTexas75246-
Texas Oncology - Northeast Texas /ID# 265890TylerTexas75702-
Intermountain Healthcare LDS Hospital /ID# 259948Salt Lake CityUtah84143-
Virginia Commonwealth University Medical Center Main Hospital /ID# 227211RichmondVirginia23219-

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The University of Arizona Cancer Center - North Campus· Tucson, AZUniversity of Arkansas for Medical Sciences· Little Rock, ARAlta Bates Summit Medical Center for Research· Berkeley, CABeverly Hills Cancer Center· Beverly Hills, CALong Beach Memorial Medical Ct· Long Beach, CAUniversity of Southern California· Los Angeles, CA

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