EUCTR2019-003474-35-IT进行中（未招募）1 期
A Phase 1/2, Open-label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of NKTR-214 in Combination with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors - PROPE
EKTAR THERAPEUTICS0 个研究点目标入组 98 人开始时间: 2021年1月22日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 98
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
- •Provide written, informed consent to participate in the study and
- •follow the study procedures.
- •Age 18 years or older at the time of signing the informed consent form
- •Life expectancy > 12 weeks as determined by the Investigator.
- •Patients may have received no more than one prior line of systemic
- •therapy for locally advanced or metastatic cancer.
- •Prior IL-2 therapy is allowed for patients in the dose optimization
- •cohorts, but not in the dose expansion cohort.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0
- •Oxygen saturation = 92% on room air for all indications; oxygen
- •saturation = 90% on room air for lung cancer considered to be due to
- •lung metastasis.
- •Measurable disease per RECIST 1.1.
- •Patients with hypertension must be on = 2 antihypertensive
- •medications and without change for the 14 days prior to randomization.
- •Screening blood pressure must be systolic < 150 mm Hg and < 90 mm
- •Hg for diastolic blood pressure.
- •A brain MRI at Screening is required for all patients with metastatic
- •NSCLC, and for patients with other tumor types who have known brain
- •metastasis.
- •Patients with brain metastases are eligible if all the criteria below are
- •- Brain metastases must be treated at least 2 weeks prior to study
- •treatment initiation. Treatment may include stereotactic radiosurgery,
- •whole brain radiotherapy, or neurosurgical resection.
- •- Brain imaging after treatment and within the screening period must
- •demonstrate no new or progressing brain metastases.
- •- No requirement for systemic corticosteroids >10 mg/day prednisone
- •equivalents. Stable doses of anticonvulsants are allowed.
- •- No clinically significant symptoms associated with brain metastases.
- •Tumor tissue sample is required for all patients. Acceptable samples
- •include archival tissue obtained no more than 12 months prior to
- •enrollment if the patient has not received systemic treatment between
- •the time of biopsy/resection and enrollment. Otherwise, a fresh tumor
- •biopsy taken during screening is required.
- •Dose Expansion Cohort (Cohort 2)
- •1L Non- Small Cell Lung Cancer (Cohorts 2.1, 2.2, and 2.3)
- •Histologically or cytologically confirmed diagnosis of NSCLC.
- •Patients must have tumor tissue samples available and sent to a
- •central laboratory for PD-L1 testing using an FDA-approved test or
- •validated assay. Approximately 20 patients will be enrolled in each
- •subgroup of PD-L1 negative (PD-L1 < 1%; Cohort 2.1), PD-L1
- •low/intermediate (PD-L1 1% to 49%; Cohort 2.2) or PD-L1 highly
- •positive (PD-L1 = 50%; Cohort 2.3).
- •Patients with epidermal growth factor receptor (EGFR) or anaplastic
- •lymphoma kinase (ALK) genomic tumor aberrations are excluded.
- •Must not have received anti-cancer therapy for advanced or metastatic
- •lung cancer.
- •Must not have progressed on or within 6 months of completing
- •adjuvant PD-L1 therapy.
- •Are the trial subjects under 18? no
- 另有 5 项未显示
排除标准
- •1. Use of an investigational agent or an investigational device within 28
- •days prior to enrollment.
- •2. Women who are pregnant or breastfeeding.
- •3. Patients who have an active, known or suspected autoimmune
- •disease. Exceptions include patients with type I diabetes mellitus,
- •hypothyroidism only requiring hormone replacement, skin disorders
- •(such as vitiligo, psoriasis, or alopecia) not requiring systemic
- •treatment, autoimmune conditions not expected to recur, or with Medical
- •Monitor approval.
- •4. History of allergy or hypersensitivity to study drug components.
- •5. Prior malignancy within the previous 3 years. Exceptions include nonmelanoma
- •skin cancer and carcinoma in situ of bladder, breast, cervix,
- •colon, prostate, stomach, and melanoma treated with curative intent,
- •with minimal risk of recurrence or requiring therapy during study
- •participation. Patients with prostate cancer are allowed if one of the
- •following criteria is met:
- •Stage T2N0M0 or lower; Gleason score = 3+4, and prostate-specific
- •antigen (PSA) below lower limit of normal by local laboratory.
- •6. Patients in the dose expansion cohort must not have received prior IL2 therapy.
- •7. Chronic systemic corticosteroid at >10 mg prednisone or equivalent or
- •other immunosuppressive agents. Patient on inhaled steroids for asthma
- •or local steroid injections are allowed.
- •8. Evidence of clinically significant interstitial lung disease or active,
- •noninfectious pneumonitis.
- •9. Surgery or radiotherapy within 14 days of enrollment. Patients who
- •had surgery or radiotherapy outside of 14 days must have recovered
- •from associated complications and toxicities.
- •10. Chemotherapy or biological therapy within 28 days of enrollment.
- •Targeted therapy (e.g., tyrosine kinase inhibitors) within 14 days of
- •enrollment.
- •11. Prior treatment with immune checkpoint inhibitor.
- •12. Active infection requiring systemic therapy.
- •13. Known hepatitis B virus (HBV) infection (e.g., positive hepatitis B
- •surface antigen [HBsAg]) or hepatitis C virus (HCV) infection (e.g.,
- •positive HCV ribonucleic acid [RNA]).
- •14. Known immunodeficiency or active human immunodeficiency virus
- •(HIV-1/2 antibodies).
- •15. Prolonged Fridericia's corrected QT interval (QTcF) > 450 ms for men
- •and > 470 ms for women at Screening.
- •16. History of unstable or deteriorating cardiac disease or
- •cerebrovascular disease within the 2 years prior to screening including
- •but not limited to the following:
- •a. Unstable angina or myocardial infarction.
- •b. Congestive heart failure (New York Heart Association [NYHA] Class
- •III or IV).
- •c. Uncontrolled clinically significant arrhythmias.
- •d. Cerebrovascular accident or transient ischemic attack
- •17. Current drug or alcohol abuse.
- •18. Any condition including medical, emotional, psychiatric, or logistical
- •that, in the opinion of the Investigator, would preclude the patient from
- 另有 2 项未显示
研究者
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