A Phase 2, single arm study on dacarbazine (DTIC) followed by immunotherapy re-challenge in unresectable or metastatic melanoma with primary resistance to PD-1/PD-L1 or PD-1 + CTLA4 BlockadePreconditioning of Tumor, Tumor Microenvironment and the Immune System to Immunotherapy (PROMIT) - PROMIT

niversity Hospital of the Friedrich-Alexander University Erlangen-Nürnberg0 个研究点目标入组 38 人开始时间: 2018年4月4日最近更新: 2020年7月27日

适应症

试验速览

暂无简介。

•Key inclusion criteria:
•1. Histologically confirmed metastatic melanoma
•2. Progression after checkpoint inhibitor therapy (anti-PD-1/PD-L1 containing regimens)
•3. Accessible tumor metastases
•4. ECOG 0 or 1
•5. Adequate organ function
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 22
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 16

•Key exclusion criteria:
•1. Uvea melanoma, mucosal melanoma
•2. Previous chemotherapy in metastatic disease
•3. Previous response to checkpoint inhibitor therapy (regimen containing PD-1 or PD-L1 inhibitors) in metastatic disease
•4. BRAF V600 mutation
•5. Active brain metastases or autoimmune disease requiring more than 10 mg prednisolone daily or other immunosuppressive drugs

发起方

niversity Hospital of the Friedrich-Alexander University Erlangen-Nürnberg