Phase 2, Randomized, Double Blinded, Study of Nivolumab (BMS-936558) in Combination with Ipilimumab vs Ipilimumab alone in Subjects with Previously Untreated, Unresectable or Metastatic Melanoma - CheckMate 069: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 069

Bristol-Myers Squibb International Corporation0 个研究点目标入组 150 人开始时间: 2013年9月5日最近更新: 2021年4月12日

适应症

试验速览

暂无简介。

•-ECOG PS 0 or 1.
•- Histologically confirmed unresectable Stage III or Stage IV Melanoma, as per AJCC staging system
•- No prior systemic anticancer therapy for unresectable or metastatic melanoma. Note that prior adjuvant or neoadjuvant melanoma therapy is permitted if it was completed at least 6 weeks prior to date of first dose, and all related adverse events have either returned to baseline or stabilized.
•- Tumor tissue obtained in the metastatic setting or from an unresectable site must be provided for biomarker analyses. In order to be treated, tumor tissue should be received by the central laboratory. In the event that lab kits are not available on-site when a subject meets all other criteria to begin treatment, the subject may begin treatment prior to tissue having been received by the central lab. In such cases, tissue should be sent to the central lab as soon as kits become available.
•-Known BRAF V600 mutation status. Subjects with either V600 wild-type or V600 mutation-melanoma are eligible.
•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 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•- Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
•-Ocular melanoma
•- Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.

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