Trial Profile
A Single-arm, Phase II Study of Durvalumab (MEDI4736) and Tremelimumab for Relapsed/Refractory Germ Cell Tumors
Status:
Active, no longer recruiting
Phase of Trial:
Phase II
Latest Information Update: 04 Jul 2023
Price :
$35
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At a glance
- Drugs Durvalumab (Primary) ; Tremelimumab (Primary)
- Indications Dysgerminoma; Germ cell cancer; Seminoma
- Focus Therapeutic Use
- 06 Jun 2023 Primary endpoint (16-wk progression free survival in a new Simons two-stage design) has not been met, according to a results presented at the 59th Annual Meeting of the American Society of Clinical Oncology.
- 06 Jun 2023 According to a results presented at the 59th Annual Meeting of the American Society of Clinical Oncology, trial amended to one cycle of D (1500 mg) and T (300 mg) followed by D (1500 mg) every 4 wks for up to 1 year (schedule 2). Primary endpoint amended to use a primary endpoint of 16-wk PFS in a new Simon's two-stage design with null and alternate rates of 5% and 25%.
- 06 Jun 2023 Results presented at the 59th Annual Meeting of the American Society of Clinical Oncology.