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Studies

Interventional Active not recruiting Phase 3

NCT05409066 on ClinicalTrials.gov

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

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)

  • Sponsor: Genmab (Group)
  • Collaborators: AbbVie
  • Enrollment: 549 (Actual)
  • Study start: 2022-09-20 (Actual)
  • Primary completion: 2029-12-01 (Estimated)
  • Study completion: 2029-12-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Follicular Lymphoma (FL)

Intervention / Treatment

  • Drug: Epcoritamab
  • Drug: Rituximab
  • Drug: Lenalidomide

Primary Outcome Measures

  • Percentage of Participants Achieving Best Overall Response (BOR) (Up to approximately 2 years and 3 months)
    BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria, as assessed by an IRC.
  • Progression-Free Survival (PFS) (Up to approximately 2 years and 3 months)
    PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by independent review committee (IRC) or death (whichever occurs first).

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, New Zealand, Poland, Puerto Rico, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States

Locations and Investigators

  • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz, Szombathely, Hungary
    • Mark, Plander
  • University Of Szeged, Szeged, Hungary
    • Szabolcs, Modok
  • Orszagos Onkologiai Intezet, Budapest XII, Hungary
    • Andras, Masszi
  • Somogy Varmegyei Kaposi Mor Oktato Korhaz, Kaposvar, Hungary
    • Peter, Rajnics
  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz, Nyiregyhaza, Hungary
    • Laszlo, Rejto
  • University Of Debrecen, Debrecen, Hungary
    • Arpad, Illes
  • Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet, Budapest IX, Hungary
    • Otto, Csacsovszki
  • Semmelweis University, Budapest VIII, Hungary
    • Zsolt, Nagy
  • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach, Kielce, Poland
    • Edyta, Ponikowska-Szyba
  • Pratia S.A., Skorzewo, Poland
    • Michal, Kwiatek
  • Aidport Sp. z o.o., Skorzewo, Poland
    • Michal, Kwiatek
  • Pratia S.A., Cracow, Poland
    • Wojciech, Jurczak
  • Szpitale Pomorskie Sp. z o.o., Gdynia, Poland
    • Wanda, Knopinska-Posluszny
  • Albert Schweitzer Ziekenhuis, Dordrecht, Netherlands
    • Eva, De Jongh
  • Dijklander Ziekenhuis, Hoorn Nh, Netherlands
    • Clara, Klerk
  • Sint Franciscus Vlietland Groep Stichting, Schiedam, Netherlands
    • Eduard, Libourel
  • Medisch Spectrum Twente, Enschede, Netherlands
    • Tjeerd, Snijders
  • OLVG Stichting, Amsterdam, Netherlands
    • Hans, Mooij
  • Deventer Ziekenhuis, Deventer, Netherlands
    • Claire, Siemes
  • Sint Antonius Ziekenhuis Stichting, Nieuwegein, Netherlands
    • Inger, Nijhof
  • Canisius Wilhelmina Hospital, Nijmegen, Netherlands
    • Caroline, Mandigers
  • Admiraal de Ruyter Ziekenhuis, Goes, Netherlands
    • Saskia, Kuipers
  • Universitair Medisch Centrum Groningen, Groningen, Netherlands
    • Marcel, Nijland
  • Leids Universitair Medisch Centrum (LUMC), Leiden, Netherlands
    • Joost, Vermaat
  • Amphia Hospital, Breda, Netherlands
    • Rinske, Boersma
  • University General Hospital Of Ioannina, Ioannina, Greece
    • Eleftheria, Hatzimichael
  • Theageneio Cancer Hospital, Thessaloniki, Greece
    • Eirini, Katodritou
  • University General Hospital Attikon, Athens, Greece
    • Panagiotis, Tsirigotis
  • Alexandra Hospital, Athens, Greece
    • Meletios-Athanasios, Dimopoulos
  • Laiko General Hospital Of Athens, Athens, Greece
    • Theodoros, Vassilakopoulos
  • Evaggelismos Hospital, Athens, Greece
    • Maria, Bouzani
  • MD Anderson Cancer Center, Madrid, Spain
    • Adolfo, De la Fuente
  • Institut Catala D'oncologia, L'hospitalet De Llobregat, Spain
    • Ana Carla, Oliveira Ramos
  • Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain
    • Sergio, Ramos Cillan
  • Clinica Universidad De Navarra, Pamplona, Spain
    • Carlos, Grande Garcia
  • Hospital Universitario Ramon Y Cajal, Madrid, Spain
    • Lopez Jimenez, Javier
  • Institut Catala D'oncologia, Badalona, Spain
    • Juan Manuel, Sancho
  • Hospital Universitario De Salamanca, Salamanca, Spain
  • Hospital General Universitario Reina Sofia, Cordoba, Spain
    • Joaquin, Sanchez
  • Hospital Universitario Marques De Valdecilla, Santander, Spain
    • Sonia, Gonzalez de Villambrosia
  • Hospital Del Mar, Barcelona, Spain
    • Blanca, Sanchez Gonzalez
  • University Hospital Virgen Del Rocio S.L., Sevilla, Spain
    • Guillermo, Rodriguez
  • Hospital De La Santa Creu I Sant Pau, Barcelona, Spain
    • Ana Carolina, Caballero Gonzalez
  • Clinica Universidad De Navarra, Madrid, Spain
    • Carlos, Grande Garcia
  • Hospital San Pedro De Alcantara, Caceres, Spain
    • Juan Miguel, Bergua Burgues
  • Hospital Universitario 12 De Octubre, Madrid, Spain
    • Ana, Jimenez
  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Palermo, Italy
    • Caterina, Patti
  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino, Turin, Italy
    • Simone, Ferrero
  • Ospedale San Raffaele S.r.l., Milan, Italy
    • Andres, Ferreri
  • Azienda Ospedaliera Universitaria Federico II Di Napoli, Naples, Italy
    • Fabrizio, Pane

And 63 other sites.

Study Officials

  • ABBVIE INC. (Study Director) — AbbVie