Trial Profile
A Phase 2 Open-Label Trial to Evaluate Enoblituzumab in Combination With Retifanlimab or Tebotelimab in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Status:
Discontinued
Phase of Trial:
Phase II
Latest Information Update: 22 Dec 2023
Price :
$35
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At a glance
- Drugs Enoblituzumab (Primary) ; Retifanlimab (Primary) ; Tebotelimab (Primary)
- Indications Head and neck cancer; Squamous cell cancer
- Focus Adverse reactions; Therapeutic Use
- Sponsors MacroGenics
- 08 Jul 2022 According to a MacroGenics media release, no additional patients in the study were to be enrolled or receive further treatments as of July 7, 2022.
- 08 Jul 2022 According to a MacroGenics media release, The incidence of fatal events observed in the study that were potentially hemorrhagic in origin was higher than what has been reported for this patient population in the medical literature and in the context of a risk : benefit analysis.
- 08 Jul 2022 According to a MacroGenics media release, this trial has been discontinued based on an internal review of safety data which is included the occurrence of seven fatalities potentially associated with hemorrhagic events in both arms. Six of the seven fatal events were secondary to disease progression and/or unrelated to the study treatment and one event was related.