A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)

Incyte Corporation0 个研究点目标入组 120 人开始时间: 2019年3月5日最近更新: 2022年8月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Incyte Corporation
入组人数: 120

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Participants are eligible to be included in the study only if all of the following criteria apply:
•1. Ability to comprehend and willingness to sign a written ICF for the study.
•2. Men and women 18 years of age or older (or as applicable per local country requirements).
•3. Confirmed diagnosis of one of the following:
•a. Treatment-naïve metastatic NSCLC with high PD-L1 expression (TPS = 50%) and no EGFR, ALK, or ROS activating genomic tumor aberrations.
•b. Locally-advanced or metastatic UC in participants who are not eligible for cisplatin therapy (determined by the investigator) and whose tumors express PD-L1 with a CPS = 10.
•c. Unresectable or metastatic melanoma.
•d. Locally advanced or metastatic RCC with clear cell component (with or without sarcomatoid features) and having received no prior systemic therapy
•4. Measurable disease per RECIST v1.1.
•5. ECOG performance status 0 to 1.
•6. Willingness to avoid pregnancy or fathering children as described in the protocol.
•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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

排除标准

•Participants are excluded from the study if any of the following criteria apply:
•1. Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug.
•2. Prior treatment with PD-1 or PD-L1 directed therapy (other immunotherapies may be acceptable with prior approval from the medical monitor).
•a. Adjuvant therapy that was completed = 12 months before study entry may be acceptable but should be discussed with the medical monitor before enrolling the participant on study.
•3. Radiotherapy within 14 days of first dose of study treatment with the following caveats:
•a. 28 days for pelvic radiotherapy.
•b. 6 months for thoracic region radiotherapy that is > 30 Gy.
•c. 14 days for palliative radiation therapy.
•Note: Participants must have recovered from all radiation-related toxicities, not require corticosteroids for this purpose, and not have had radiation pneumonitis.
•4. Toxicity of prior therapy that has not recovered to = Grade 1 or baseline (with the exception of anemia not requiring transfusion support and any grade of alopecia). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with sponsor medical monitor.
•5. Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
•6. Participants with laboratory values at screening as defined in Table 7 of the protocol.
•7. Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm,
•carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for > 1 year, after treatment with curative intent.
•8. Activeautoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent).
•a. Physiologic corticosteroid replacement therapy at doses > 10 mg/day of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.
•b. Participants with asthma that requires intermittent use of
•bronchodilators, inhaled steroids, or local steroid injections may participate.
•c. Participants using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.
•d. Brief courses of corticosteroids for prophylaxis (eg, contrast dye allergy) or study treatment–related standard premedication are permitted.
•9. Evidence of interstitial lung disease or active noninfectious pneumonitis.
•10. Known active CNS metastases and/or carcinomatous meningitis.
•11. Known active HBA, HBV, or HCV infection, as defined by elevated transaminases with the following serology: positivity for HAV IgM antibody, anti-HCV, anti-HBc IgG or IgM, or HBsAg (in the absence of prior immunization).
•12. Active infections requiring systemic therapy.
•13. Participants who are known to be HIV-positive, unless all of the following criteria are met:
•a. CD4+ count = 300/µL, b. Undetectable viral load , c. Receiving highly active antiretroviral therapy.
•14. Known hypersensitivity to another mAb that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).

研究者

发起方

Incyte Corporation

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