A Study to Evaluate the Safety and Efficacy of MGD013 in Patients With Melanoma (NCT04653038) | Clinical Trial Compass
TerminatedPhase 1
A Study to Evaluate the Safety and Efficacy of MGD013 in Patients With Melanoma
Stopped: rapid changes in the treatment mode of melanoma worldwide and in China and the development strategy change
China92 participantsStarted 2020-10-29
Plain-language summary
This is an open-label, multi-cohort, multi-center Phase I clinical trial to evaluate the efficacy and safety of MGD013 in ①Cohort 1: patients with unresectable, recurrent or metastatic melanoma who have failed prior immune checkpoint inhibitor therapy; ② Cohort 2: patients with untreated, unresectable recurrent or metastatic, mucosal or acral lentiginous melanoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Voluntary and able to provide signed informed consent form
* Male or female aged ≥ 18 years
* Patient can comply with protocol requirements as assessed by the investigator
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, or 1
* Histologically confirmed unresectable recurrent or metastatic melanoma:
* Cohort 1: The pathological type is cutaneous or acral lentiginous, or unknown origin. Progressive or recurrent disease on at least one prior line of systemic therapies. In addition, prior systemic therapies must include one line of anti-PD-(L)1 and/or anti-CTLA-4 immune checkpoint inhibitors. Patients with BRAF-mutated or KIT-mutated/amplified melanoma, and prior treatment with vemurafenib or imatinib is not mandatory;
* Cohort 2: Histologically confirmed pathological type is acral lentiginous or mucosal. No prior systemic therapy for recurrent or metastatic disease.
* Patients with at least one measurable lesion according to irRECIST; assessed by investigator per irRECIST criteria to establish a baseline tumor assessment, and should be performed within 28 days prior to the first dose.
Exclusion Criteria:
* The pathological type of patient is:
* Cohort 1: Mucosal melanoma; uveal melanoma;
* Cohort 2: Cutaneous melanoma; uveal melanoma; melanoma of unknown origin; known BRAF mutation or KIT mutation/amplification.
* Central nervous system metastases with clinical symptoms. Patients with prior central nervous system metas…