GCT3013-05 - A Phase 3 Trial of Epcoritamab vs SOC in R/R DLBCL

• Research type

  Research Study

• Full title

  A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator’s Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma

• IRAS ID

  286972

• Contact name

  Christopher Fox

• Contact email

  Christopher.Fox2@nuh.nhs.uk

• Sponsor organisation

  Genmab A/S

• Eudract number

  2020-003016-27

• Clinicaltrials.gov Identifier

  NCT04628494

• Clinicaltrials.gov Identifier

  IND, 135659

• Duration of Study in the UK

  3 years, 7 months, 16 days

• Research summary

  This is an open-label (participant and doctor know which medication will be given), global, Phase 3 trial of epcoritamab versus pre-specified investigator’s choice of chemotherapy in subjects with Relapsed (reappeared) or Refractory (no response to treatment) (R/R) diffuse large B-cell lymphoma (DLBCL) who failed or are ineligible for autologous stem cell transplant (ASCT). Every participant has either the chance to receive epcoritamab or investigator’s choice of chemotherapy; sites will choose 1 of 2 chemotherapy options in advance: Rituximab+ Gemcitabine and Oxaliplatin (R-GemOx) or Bendamustine-Rituximab (BR).

  Approximately 480 subjects (240 in each arm) will be enrolled in the trial with a primary endpoint of Overall Survival.
  In the epcoritamab arm, treatment will be administered as subcutaneous (Under the skin) injections using a step-up dosing method: priming dose at 0.16 mg on Cycle 1 Day 1, followed by intermediate dose at 0.8 mg on C1D8, and then full doses at 48 mg on C1D15 and C1D22. Each treatment cycle is 28 days. Full doses (48 mg) will be then given on Days 1, 8, 15, 22 of C2 and 3, D1 and D15 of C4-9, and D1 of cycles thereafter (C10+), with treatment until progressive disease or unacceptable toxicity.
  In the Investigator’s choice arm, subjects will receive one of the following:
  o R-GemOx: rituximab 375 mg/m2 IV on D1 and D15 and gemcitabine 1000 mg/m2 IV followed by oxaliplatin 100 mg/m2 IV on D2 and D16 of each 28-day cycle for up to 4 cycles (8 doses)
  o BR: rituximab 375 mg/m2 IV on Day 1 and bendamustine 90 mg/m2 IV on D1 and D2 of each 21-day cycle for up to 6 cycles

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  20/SC/0326

• Date of REC Opinion

  11 Jan 2021

• REC opinion

  Further Information Favourable Opinion