EUCTR2020-000157-27-RO进行中（未招募）1 期
A Phase 2 Study of INCB086550 (Oral PD-L1 Inhibitor) in Participants Who Are Immune Checkpoint Inhibitor–Naïve With Selected Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 304
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
- •1. Ability to comprehend and willingness to sign a written ICF for the study.
- •2. Men and women 18 years of age or older.
- •3. Measurable disease per RECIST v1.1.
- •4. ECOG performance status of 0 to 1 for all tumor types. Urothelial carcinoma allows ECOG of 0 to 2.
- •5. Histologically or cytologically confirmed disease-specific diagnosis as follows:
- •a. Treatment-naïve, stage IV NSCLC (AJCC v8) in participants whose tumors express PD-L1 TPS = 50% using the Dako PD-L1 IHC 22C3 assay and who have no known activating genomic aberrations that require targeted therapy (eg, EGFR, ALK, ROS, BRAF).
- •b. Locally advanced, and unresectable or metastatic UC of the renal pelvis, ureter, bladder, or urethra (including transitional cell and mixed transitional or nontransitional cell histologies) in participants who are cisplatin-ineligible, who are immune checkpoint inhibitor–naïve, and whose tumors express high PD-L1 (CPS = 10) using the Dako PD-L1 IHC 22C3 assay.
- •c. Advanced HCC that is not amenable to curative surgery or local treatment in participants who have received at least 1 previous line of systemic therapy (ie, sorafenib or lenvatinib) or who were intolerant of sorafenib/lenvatinib treatment, have a Child-Pugh score of = 6 (Child-Pugh A), and who are immune checkpoint inhibitor–naïve. Exception for HCC: Participants without access to prior systemic therapy (ie, sorafenib or lenvatinib).
- •d. Advanced or metastatic RCC with a clear cell component with or without sarcomatoid features in participants who have received prior systemic therapy for their disease (up to 2 previous regimens of a VEGF or mTOR inhibitor) and who are immune checkpoint inhibitor–naïve.
- •Exception for RCC: Participants without access to prior systemic therapy (ie, VEGF or mTOR inhibitors).
- •e. Unresectable stage III or IV melanoma (excluding ocular/uveal melanoma) in participants who are immune checkpoint inhibitor–naïve. BRAF V600 mutation status must be known.
- •Exception for melanoma: Participants may have received 1 prior line of therapy. This therapy could include previous treatment with BRAF/MEK inhibitors in participants with known BRAF V600 mutation or chemotherapy.
- •6. Willingness to avoid pregnancy or fathering children.(CTFG 2020).
- •7. Participants must have radiologic documentation of disease progression after treatment with available therapies except for participants with NSCLC, who are required to be treatment-naïve.
- •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 152
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 152
排除标准
- •1. Prior receipt of an anti–PD-1, anti–PD-L1, or anti–PD-L2 agent, or treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL2, 4-1BB, CAR-T).
- •2. Receipt of any anticancer therapy or participation in another interventional clinical study.
- •3. Radiotherapy within 14 days of first dose of study treatment (28 days for pelvic radiotherapy or 6 months for thoracic region radiotherapy that is > 30 Gy).
- •4. Concomitant treatment with moderate and potent CYP3A4/CYP3A5 inhibitors or inducers
- •5. 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).
- •6. Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
- •7. Participants with laboratory values at screening as defined in the protocol.
- •8. Active malignancy of a type not included in the study population requiring treatment.
- •9. Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent).
- •10. Evidence of interstitial lung disease or active, noninfectious pneumonitis.
- •11. Untreated or known active CNS metastases and/or carcinomatous meningitis.
- •12. With the exception of participants with HCC, known active HAV, 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).
- •Note: For participants with cleared prior HBV infection: HBV prophylaxis should be considered per investigator discretion. Monitor for HBV reactivation every 3 cycles by performing HBV viral load and HBsAg serology test. Additional viral serologic testing may be performed at the investigator's discretion.
- •13. Active infection requiring systemic therapy.
- •14. Receipt of systemic antibiotics within 28 days of first dose of study treatment.
- •15. Probiotic usage during screening and throughout the study treatment period.
- •16. Participants who are known to be HIV-positive.
- •17. Participants with impaired cardiac function or clinically significant cardiac disease:
- •a. New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant ventricular arrhythmia, congestive heart failure, or cardiomyopathy.
- •b. Unstable angina pectoris = 6 months before study participation.
- •c. Acute myocardial infarction = 6 months before study participation.
- •d. Other clinically significant heart disease (ie, = Grade 3 hypertension, history of labile hypertension, or poor compliance with an antihypertensive regimen) must have recovered (to baseline or = Grade 1) from toxicity associated with prior treatment.
- •18. History or presence of an ECG finding that, in the investigator's opinion, is clinically meaningful. sponsor approval.
- •19. Female participant is pregnant or breastfeeding within the projected duration of the study, starting with the screening visit through the 90-day safety follow-up, or male participant is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 100 days after the last dose of study treatment.
- •20. Has received a live vaccine within 90 days of the planned start of study drug.
- •21. Current use of a prohibited medication as described in the protocol.
- •22. Life expectancy < 3 months.
研究者
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