EUCTR2018-002941-12-PL进行中（未招募）1 期
A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •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. Active autoimmune disease requiring systemic immunosuppression in
- •excess of physiologic maintenance doses of corticosteroids (> 10 mg of
- •prednisone or equivalent)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
- •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
- 另有 10 项未显示
研究者
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