EUCTR2016-003334-25-DE进行中（未招募）1 期
A phase II trial of nivolumab in combination with ipilimumab to evaluate efficacy and safety in relapsed lung cancer and to evaluate biomarkers predictive for response to immune checkpoint inhibition
niversity of Cologne0 个研究点目标入组 90 人开始时间: 2016年11月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- •Note: Cohort 1 is closed for enrollment. Subjects who started screening for cohort 1 prior to stop of recruitment initiated by Coordinating PI on April 25 2019 will continue to receive treatment.
- •Cohort 1: Subjects with histologically or cytologically confirmed advanced non-squamous non-small cell lung cancer who present with stage IIIB/IV disease after failure of platinum-based first-line therapy (second line). Subjects who received adjuvant/neoadjuvant therapy or definitive chemoradiation and develop recurrence or progression, with evidence of stage IIIB-IV disease within 6 months after completion of therapy, are eligible.
- •Cohort 2a: Subjects with histologically or cytologically confirmed limited-stage or extensive-stage small cell lung cancer after failure of platinum-based first-line therapy with or without anti-PD-1/PD-L1 treatment.(TMB non-discrimated SCLC patients).
- •Note: Cohort 2a is closed for enrollment.
- •Cohort 2b: Subjects with histologically or cytologically confirmed limited-stage or extensive-stage TMB high small cell lung cancer after failure of platinum-based first-line therapy with or without anti-PD-1/PD-L1 treatment.Inclusion after 2nd line Topotecan-Therapy is allowed. Only TMB high SCLC patients are included, as tested on tumor material during routine biopsies for first diagnosis (whole exome sequencing on FFPE tissue). For definition of TMB high, please refer to chapter 5.5.1.2
- •The following inclusion criteria apply for Cohort 1, 2a and 2b:
- •Signed and dated IRB/IEC-approved written informed consent form must be obtained before the performance of any study-specific procedure
- •Male or female patients over 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- •Subjects must be willing to undergo at baseline screening biopsy.
- •Subjects must be considered as suitable for conduction of 2 biopsies (baseline and in case of progression) by the responsible local investigator.
- •Measurable disease by CT or MRI per RECIST 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented disease progression in that site after completion of radiation therapy
- •Subjects with CNS metastases are eligible if CNS metastases are treated and subjects have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 28 days prior to first dose of study drug administration. In addition, subjects must either be off corticosteroids or on a stable dose or decreasing dose of = 10 mg daily prednisone (or equivalent).
- •Cohort 2b: Subjects with CNS metastases are eligible. Radiation of CNS metastases at initiation of study drug treatment is allowed if the trial subject has target lesions outside of the brain.
- •Note for Cohort 2b: higher doses of corticosteroids for patients receiving radiation therapy of brain metastases are allowed
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •Subjects with squamous cell NSCLC
- •For Cohort 1 only: EGFR activating mutation or ALK translocation
- •More than one prior line of chemotherapy for treatment of advanced disease
- •Medical conditions associated with significantly increased risk for bleeding complications caused by biopsy procedures (e.g. known coagulopathies, therapeutic anticoagulation)
- •Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for 4 weeks after treatment has been completed and within 28 days prior to the first dose of study drug administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
- •Presence or history of any other primary malignancy other than non-squamous NSCLC for Cohort 1 and SCLC for Cohort 2a/2b within 5 years prior to enrolment into the trial, except for adequately treated basal or squamous cell carcinoma of the skin or any adequately treated in situ carcinoma.
- •Subjects with active, known or suspected autoimmune disease. Subjects are permitted to enrol if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
- •Positive test for hepatitis B virus surface antigen (HBV sAg or HBV-DNA) or hepatitis C virus ribonucleic acid (HCV-RNA) indicating acute or chronic infection
- •Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- •Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug administration. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
- •Note for Cohort 2b: higher doses of corticosteroids for patients receiving radiation therapy of brain metastases are allowed
- •Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
- •Prior systemic treatment 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
- •Note for Cohort 2b: inclusion of patients who received 2nd line treatment is allowed if 2nd line did not include an anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody as monotherapy or in combination with other than platinum-based chemotherapy.
- •Any other serious or uncontrolled medical disorder, active infections, physical exam findings, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject’s ability to comply with the study requirements, substantially increase risk to the subject, or negatively impact the interpretation of study results.
- •History of allergies or severe hypersensitivity reaction to study drug components or to any monoclonal antibody
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