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A Phase 1/2 Multicenter, Single-Arm, Open-Label, Dose-Escalation Study of Birinapant in Combination With Pembrolizumab (KEYTRUDA) in Patients With Relapsed or Refractory Solid Tumors

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Trial Profile

A Phase 1/2 Multicenter, Single-Arm, Open-Label, Dose-Escalation Study of Birinapant in Combination With Pembrolizumab (KEYTRUDA) in Patients With Relapsed or Refractory Solid Tumors

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 12 May 2022

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At a glance

  • Drugs Birinapant (Primary) ; Pembrolizumab (Primary)
  • Indications Carcinoma; Cervical cancer; Cholangiocarcinoma; Colorectal cancer; Fallopian tube cancer; Gastric cancer; Head and neck cancer; Mesothelioma; Oesophageal cancer; Osteosarcoma; Ovarian cancer; Peritoneal cancer; Small cell lung cancer; Solid tumours; Squamous cell cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Medivir AB

Most Recent Events

  • 16 Dec 2019 Results of futility analysis (n=14, phase II) presented in a Medivir AB media release.
  • 16 Dec 2019 Status changed from recruiting to discontinued, according to a Medivir AB media release.
  • 16 Dec 2019 According to a Medivir AB media release, the independent safety committee (IDMC) for this phase II study of birinapant in combination with pembrolizumab (Keytruda) in patients with MSS colorectal cancer has performed the planned futility analysis.IDMC's recommendation is that the study should be terminated as the analysis indicates that it is unlikely that the study's objectives will be met. Medivir has therefore decided to discontinue the recruitment of patients and to end the study.

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