A Phase I /II Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-KIR (Lirilumab) Administered in Combination with Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors

Bristol-Myers Squibb International Corporation0 个研究点目标入组 171 人开始时间: 2016年8月17日最近更新: 2019年12月16日

适应症

试验速览

暂无简介。

•1) Signed Written Informed Consent
•2) Target Population
•a) Subjects must have histologic or cytologic confirmation of a solid malignancy that is advanced (metastatic and/or unresectable):for Cohort Expansion part 2
•Head and Neck Squamous Cell Carcinoma (SCCHN) (oral cavity, pharynx, larynx)
•ii. Subjects must have = 5 prior treatment regimens. The following are not considered separate lines of treatment: addition of a compound to an on-going regimen, re-starting the same regimen after a drug holiday, or switching from intravenous to oral therapy
•b) Presence of at least one lesion with measurable disease as defined by RECIST v1.1
•criteria for response assessment.
•c) ECOG status of 0 or 1.
•fd Life expectancy of = 12 weeks.
•3) Age, Sex, and Reproductive Status
•a) Men and women, ages > 18.
•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 14
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•1) Target Disease Exceptions
•2) Medical History and Concurrent Diseases
•a. Subjects with a prior malignancy are excluded, except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, localized prostate cancer, carcinoma in situ of the cervix, or in situ ductal or lobular carcinoma of the breast.
•b. Subjects with any active autoimmune disease or history of known or suspected autoimmune disease, with the exception of subjects with isolated vitiligo, resolved childhood asthma/atopy, and controlled thyroid disorders.
•3) Prohibited Prior Treatments and/or Therapies
•a. Prior therapy with an anti-KIR, anti-PD-1, or anti-PD-L1, antibody.
•b. Prior treatment regimens with any immune cell modulating antibody such as anti-CD137 and anti-OX40.
•c. Exposure to any other investigational drug within 4 weeks prior to the first dose of study drug (within 101 days for anti-CTLA4 therapy).
•d. Any anti-cancer therapy (e.g., chemotherapy, biologics, vaccines, radiotherapy with curative intent, or hormonal treatment) within 4 weeks prior to the first dose of study drug administration (within 101 days for anti-CTLA4 therapy), with the exception of GnRH agonist therapy for subjects with prostate cancer.
•4) Physical and Laboratory Test Findings
•5) Sex and Reproductive Status
•a) Women who are pregnant or are breastfeeding.

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