A Multi-Cohort Study of MK-2140 in Combination With SoC in DLBCL

• Research type

  Research Study

• Full title

  A Phase 2/3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-003)

• IRAS ID

  1006880

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Eudract number

  2021-003313-18

• Clinicaltrials.gov Identifier

  NCT05139017

• Research summary

  Given the high risk of progression in rrDLBCL (relapsed or refractory diffuse large B-cell lymphoma), this patient population represents a high unmet medical need for more effective and tolerable treatment.

  This trial is testing zilovertamab vedotin (MK-2140) in people with rrDLBCL. Zilovertamab vedotin has not been approved to treat people with rrDLBCL or any other type of cancer. Zilovertamab vedotin targets a protein made by B-cell cancers called ROR1 (receptor tyrosine kinase-like orphan receptor 1). It is not known if the different amounts of ROR1 expressed by different cancers impacts whether MK-2140 works.
  R-GemOx, which includes rituximab (or Truxima® or Ruxience®), gemcitabine, and oxaliplatin is the standard treatment for rrDLBCL.
  This trial will compare zilovertamab vedotin given with standard treatment, R-GemOx, to R-GemOx given alone.
  This trial has 2 parts. About 420 male and female participants, aged 18 or older will take part in the trial, 60 in Part 1 (Dose Confirmation) and 360 in Part 2 (Efficacy Expansion). The part that participants are placed in will depend on when they join the trial.

  There is a screening phase to see if patients can join the trial lasting about one month.
  Eligible participants will receive treatment for about 5 months. Participants will receive Zilovertamab vedotin + R-GemOx in Part 1, and either Zilovertamab vedotin + R-GemOx or R-GemOx only in Part 2. Participants will then enter the Follow-up Phase.
  During the study, participants will undergo procedures such as physical examinations, ECGs, blood/urine samples and scans.

  The Sponsor estimates that the trial will require approximately 7 years from the time the first participant agrees to take part until the last trial related contact.

  The trial is sponsored by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc. (MSD).

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  22/EE/0286

• Date of REC Opinion

  17 Feb 2023

• REC opinion

  Further Information Favourable Opinion