NL-OMON50077已完成不适用
Safety and tolerability of neoadjuvant nivolumab for locally advanced resectable oral cancer, combined with [18F]BMS-986192 / [18F]-FDG PET imaging and immunomonitoring for response prediction. - NeoNivo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Histologically confirmed diagnosis of locally advanced oral cancer (stage
- •III/IV) which is planned for treatment with curative intent includiing surgical
- •- Must provide tissue from fresh tumor biopsy pretreatment and from the
- •surgical resection material to determine actual PD-L1 status and perform
- •immunomonitoring and DNA/RNA profiling.
- •- Willing to allow up to two additional biopsies when baseline [18F]BMS-986192
- •PET /[18F]-FDG PET scans show heterogeneous and/or discrepant uptake.
- •- ECOG performance scale 0-1
- •- Have adequate organ function (hematological, renal and hepatic) as
- •demonstrated by screening laboratory test.
- •- Women of childbearing potential must use appropriate method(s) of
- •contraception during the study and for 23 week after the last dose of nivolumab
- •- Men who are sexually active with women of childbearing potential must use any
- •contraceptive method with a failure rate of less than 1% per year.
排除标准
- •- Is currently participating in or has participated in a study of an
- •investigational agent within 4 weeks of the first dose of treatment or has not
- •recovered (i.e., * Grade 1 or at baseline) from adverse events due to agents
- •administered more than 4 weeks earlier.
- •- Has a known current additional malignancy that is progressing or requires
- •active treatment. Exceptions include basal cell carcinoma of the skin, squamous
- •cell carcinoma of the skin, or in situ cervical cancer that has undergone
- •potentially curative therapy or synchronous head and neck squamous cell
- •- If subject received major surgery for any other reason, they must have
- •recovered adequately from the toxicity and/or complications from the
- •intervention prior to starting therapy.
- •- Subjects with a condition requiring systemic treatment with either
- •corticosteroids (> 10 mg daily prednisone equivalent) or other
- •immunosuppressive medications within 14 days of day -5. Inhaled or topical
- •steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent,
- •are permitted in the absence of active autoimmune disease.
- •- Has an active autoimmune disease requiring systemic steroid treatment within
- •the past 3 months or a documented history of clinically severe autoimmune
- •disease, or a syndrome that requires systemic steroids.
- •- Has evidence of interstitial lung disease or active, non-infectious
- •pneumonitis.
- •- Has an active infection requiring systemic therapy.
- •- Has a history or current evidence of any condition, therapy, or laboratory
- •abnormality that might confound the results of the trial, interfere with the
- •subject*s participation for the full duration of the trial, or is not in the
- •best interest of the subject to participate, in the opinion of the treating
- •investigator.
- •- Has known psychiatric or substance abuse disorders that would interfere with
- •cooperation with the requirements of the trial.
- •- Is pregnant or breastfeeding, or expecting to conceive or father children
- •within the projected duration of the trial, starting with the pre-screening or
- •screening visit through 23 weeks after the last dose of trial treatment.
- •- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2,
- •anti-CTLA-4 antibody, or any other antibody or drug specifically targeting
- •T-cell costimulation or immune checkpoint pathways.
- •-Has a known history of Human Immunodeficiency Virus infection with a
- •detectable viral load. Patients with an undetectable load (<50 copies/ml)
- •receiving adequate anti-retroviral therapy, are allowed to participate.
- •- Has known active Hepatitis B or C.
研究者
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