EUCTR2016-002621-10-HU进行中（未招募）1 期
A Phase IIIb/IV Safety Trial of Flat Dose Nivolumab in Combination with Ipilimumab in Participants with non-small cell lung cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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) Signed Written Informed Consent
- •2) Type of Participant/Target Disease Characteristics
- •a) Eastern Cooperative Oncology Group Performance Status of less or equal to 1.
- •b) Cohort A (1st-line NSCLC):
- •i) Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy (including EGFR and ALK inhibitors) given as primary therapy for
- •advanced or metastatic disease.
- •(1)Prior adjuvant or neoadjuvant chemotherapy is permitted as long as the last administration of the prior regimen occurred at least 6 months prior to enrollment.
- •(2)Prior definitive chemoradiation for locally advanced disease is also permitted as long as the last administration of chemotherapy or radiotherapy (which ever was given last) occurred at least 6 months prior to enrollment.
- •c) Cohort B (second-line NSCLC)
- •i) Subjects with histologically- or cytologically-documented squamous or non-squamous cell NSCLC who present with Stage IIIB/ Stage IV disease (per IASLC), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiation therapy for locally advanced disease).
- •ii) Subjects must have experienced disease recurrence or progression during or after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease.
- •(1).Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate regimen of therapy
- •(2).Subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible.
- •(3).Subjects with recurrent disease > 6 months after platinumcontaining adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a platinum doublet-based regimen given to treat the recurrence, are eligible.
- •d) Evaluable disease by computed tomography (CT) or magnetic resonance imaging (MRI); radiographic tumor assessment performed within 28 days of start of study treatment.
- •e) Participants must have tissue submitted for PD-L1 immunohistochemical (IHC) testing prior to the treatment assignment. If PD-L1 IHC testing has already been conducted during screening for another BMS study, it does not need to be repeated for CA209817.
- •i) Either a formalin-fixed, paraffin-embedded (FFPE) tissue block or unstained tumor tissue sections, with an associated pathology report, must be submitted for biomarker evaluation prior to treatment assignment. The tumor tissue sample may be fresh or archival if obtained within 12 months prior to enrollment (6 months for slides).
- •ii) Tissue must be a core needle biopsy, excisional or incisional biopsy. Fine needle biopsies or drainage of pleural effusions with cytospins are not considered adequate for biomarker review. Biopsies of bone lesions that do not have a soft tissue component or decalcified bone tumor samples are also not acceptable.
- •(1).Samples collected via other procedures, including, but not limited to, endobronchial ultrasound (EBUS) guided biopsy, transbronchial lung biopsy (TBLB) may be approved by the BMS medical monitor (MM)/study director (SD) on a case by case basis.
- •f) Prior palliative radiotherapy to non-central nervous system (CNS) lesions must have been completed at least 2 we
排除标准
- •1) Target Disease Exceptions
- •a) Subjects with known EGFR mutations which are sensitive to available
- •targeted inhibitor therapy (including, but not limited to, deletions in
- •exon 19 and exon 21 [L858R] substitution mutations) are excluded. All
- •subjects with non-squamous histology must have been tested for EGFR
- •mutation status; use of an FDA-approved test is strongly encouraged.
- •Subjects with non-squamous histology and unknown or indeterminate
- •EGFR status are excluded.
- •b) Subjects with known ALK translocations which are sensitive to
- •available targeted inhibitor therapy are excluded. If tested, use of an
- •FDA-approved test is strongly encouraged. Subjects with unknown or
- •indeterminate ALK status may be enrolled.
- •2) Medical Conditions
- •a) Participants with untreated CNS metastases are excluded.
- •i) Participants are eligible if CNS metastases are adequately treated and
- •participants are neurologically returned to baseline (except for residual
- •signs or symptoms related to the CNS treatment) for at least 2 weeks
- •prior to treatment assignment. In addition, participants must be either
- •off corticosteroids, or on a stable or decreasing dose of less or equal to
- •10 mg daily prednisone (or equivalent) for at least 2 weeks prior to
- •treatment assignment.
- •b) Participants with carcinomatous meningitis.
- •c) Participants must have recovered from the effects of major surgery or
- •significant traumatic
- •injury at least 14 days before treatment assignment.
- •d) Active malignancy requiring concurrent intervention.
- •e) Participants with an active, known or suspected autoimmune disease.
- •Participants with type I diabetes mellitus, hypothyroidism only requiring
- •hormone replacement, skin disorders (such as vitiligo, psoriasis, or
- •alopecia) not requiring systemic treatment, or conditions not expected
- •to recur in the absence of an external trigger are permitted to enroll.
- •f) Participants with a condition requiring systemic treatment with either
- •corticosteroids (> 10 mg daily prednisone equivalent) or other
- •immunosuppressive medications within 14 days of treatment
- •assignment. Inhaled or topical steroids, and adrenal replacement steroid
- •> 10 mg daily prednisone equivalent, are permitted in the absence of
- •autoimmune disease.
- •g) Participants with interstitial lung disease that is symptomatic or may
- •interfere with the detection or management of suspected drug-related
- •pulmonary toxicity.
- •h) Known history of testing positive for human immunodeficiency virus
- •(HIV) or known acquired immunodeficiency syndrome (AIDS).
- •i) Known medical condition that, in the investigator's opinion, would
- •increase the risk associated with study participation or study drug
- •administration or interfere with the interpretation of safety results.
- •3) Prior/Concomitant Therapy
- •a) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-
- •CD137, or anti-CTLA-4 antibody, or any other antibody or drug
- •specifically targeting T-cell co-stimulation or checkpoint pathways
- •4) Physical and Laboratory Test Findings
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