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A Phase III, Randomized, Open-label, Clinical Trial to Compare Pembrolizumab With Brentuximab Vedotin in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma

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Trial Profile

A Phase III, Randomized, Open-label, Clinical Trial to Compare Pembrolizumab With Brentuximab Vedotin in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Sep 2023

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At a glance

  • Drugs Pembrolizumab (Primary) ; Brentuximab vedotin
  • Indications Hodgkin's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-204
  • Sponsors Merck Sharp & Dohme; Merck Sharp & Dohme Corp.

Most Recent Events

  • 17 Jun 2022 Results from four KEYNOTE-013 (NCT01953692, n=20), KEYNOTE-087 (NCT02453594, n=31), KEYNOTE-170 (NCT02576990, n=5), and KEYNOTE-204 (NCT02684292) trials presented at the 27th Congress of the European Haematology Association
  • 17 Mar 2021 According to a Merck and Co media release, the European Commission (EC) approval is based on results from the pivotal Phase 3 KEYNOTE-204 trial and supportive data from an updated analysis of the KEYNOTE-087 trial.
  • 17 Mar 2021 According to a Merck and Co media release, the European Commission (EC) has approved an expanded label for KEYTRUDA (pembrolizumab), as monotherapy for the treatment of adult and pediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.

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