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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 Follicular Lymphoma

Study acronym: EPCORE FL-1
StatusActive, Not Recruiting
PhasePhase 3
SponsorGenmab
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 151 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Study sites revised (273)v151 See this version in full on ClinicalTrials.gov ↗
  2. Primary and study completion dates: Oct 2030 to Dec 2029 Study sites revised (273)v150 Show 1 more changeShow less
    • Study sites revised (273)

    See this version in full on ClinicalTrials.gov ↗

  3. Primary endpoints: 1 to 2 Secondary endpoints: 3 to 19 · Study sites revised (273)v149 Show 2 more changesShow less
    • Secondary endpoints: 3 to 19
    • Study sites revised (273)

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 500 to confirmed 549 · Study sites revised (273)v148 Show 2 more changesShow less
    • Enrollment target: estimated 500 to confirmed 549
    • Study sites revised (273)

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 24 of 273 sitesv147
Show 45 earlier versionsHide 45 earlier versions
  1. Primary completion date: Nov 15, 2029 to Oct 2030 Study sites: 263 to 273 · Completion date: Jun 16, 2030 to Oct 2030v146 Show 2 more changesShow less
    • Study sites: 263 to 273
    • Completion date: Jun 16, 2030 to Oct 2030
  2. Study sites: 260 to 263v145
  3. Study sites: 254 to 260v144
  4. Study sites: 247 to 254v143
  5. Study sites: 244 to 247v142
  6. Lead sponsor: AbbVie to Genmab Study sites: 234 to 244 · Eligibility criteria expanded, about 7 words · Collaborator revisedv141 Show 3 more changesShow less
    • Study sites: 234 to 244
    • Eligibility criteria expanded, about 7 words
    • Collaborator revised

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 233 to 234v140
  8. Study sites revised (233)v139 See this version in full on ClinicalTrials.gov ↗
  9. Study sites: 232 to 233v138
  10. Study sites: 230 to 232v137
  11. Study sites: 227 to 230v136
  12. Study sites: 225 to 227v135
  13. Site details revised at 1 of 225 sitesv134
  14. Re-verified, no change to tracked fieldsv133
  15. Study sites revised (225)v132 See this version in full on ClinicalTrials.gov ↗
  16. Study sites: 224 to 225v131
  17. Study sites: 221 to 224v130
  18. Study sites: 220 to 221v129
  19. Study sites: 219 to 220v128
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  26. Study sites: 207 to 209v121
  27. Re-verified, no change to tracked fieldsv120
  28. Study sites: 206 to 207v119
  29. Study sites: 205 to 206v118
  30. Study sites: 204 to 205v117
  31. Study sites: 201 to 204v116
  32. Study sites: 200 to 201v115
  33. Re-verified, no change to tracked fieldsv114
  34. Study sites: 195 to 200v113
  35. Study sites: 194 to 195v112
  36. Study sites: 193 to 194v111
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  38. Study sites: 186 to 188v109
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  43. Study sites: 178 to 180v104
  44. Study sites: 177 to 178v103
  45. Study sites: 174 to 177v102
  • 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.
Genmab
45 trials monitored
See 3 trials at risk
Follicular Lymphoma
313 trials monitored
See 26 trials at risk
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.
Trial Details
NCT Number NCT05409066
Lead Sponsor Genmab
Collaborators: AbbVie
Conditions Follicular Lymphoma (FL)
Enrollment 549 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov