An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumabin combination with Ipilimumab in Subjects with Treatment-Naive Stage IVor recurrent Non-Small Cell Lung Cancer (NSCLC) - ooo

BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO0 个研究点目标入组 250 人开始时间: 2021年6月17日最近更新: 2021年8月10日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO
入组人数: 250

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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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 and Target Disease Characteristics
•a) Subjects 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. 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. Prior
•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.
•b) Measurable disease by CT or MRI per RECIST 1.1 criteria. Tumor
•assessment performed within 28 days of start of study treatment.
•c) All participants must have tissue submitted during screening. This
•may include either a formalin-fixed paraffin-embedded (FFPE) tissue
•block or a minimum of 15 unstained tumor tissue slides.
•Part 1: For cohort assignment purposes (PD-L1 status determination),
•archival tissue samples = 3 months old will be allowed to determine PDL1
•IHC results. Fresh pre-dose biopsy samples (5 cores: 3 in FFPE and 2
•in HypoThermosol®) will still need to be submitted.
•Part 2: a fresh biopsy (preferred) or archival sample (= 3 months old) is
•required for enrollment, but treatment may start before test results are
•d) ECOG Performance Status 0 or 1.
•3) Age and Reproductive Status
•a) Males and Females, ages 18 years (or age of majority) and older.
•b) Women of childbearing potential (WOCBP) must have a negative
•serum or urine pregnancy test (minimum sensitivity 25 IU/L or
•equivalent units of HCG) within 24 hours prior to the start of study
•c) Women must not be breastfeeding.
•d) Women of childbearing potential must agree to follow instructions for
•method(s) of contraception for the duration of treatment followed by a
•period of 30 days (duration of ovulatory cycle) plus the time required for
•the investigational drug to undergo five half-lives. WOCBP treated with
•nivo + ipi combination should use an adequate method to avoid
•pregnancy for 5 months (30 days plus the time required for nivolumab to
•undergo five half-lives) after the last dose of investigational drug.
•e) Males who are sexually active with WOCBP must agree to follow
•instructions for method(s) of contraception for the duration of treatment
•followed by a period
•of 90 days (duration of sperm turnover) plus the time required for the
•investigational drug to undergo five half-lives. Males treated with nivo +
•ipi combination who are sexually active with WOCBP must continue
•contraception for 7 months (90 days plus the time required for
•nivolumab to undergo five half-lives) after the last dose of
•investigational drug. In addition, male participants must be willing to
•refrain from sperm donation during this time.
•f) Azoospermic males are exempt from contraceptive requirements.
•WOCBP who are continuously not heterosexually active are also exempt
•from contraceptive requirements, and still must undergo pregnancy
•testing as described in this section.
•Are the trial subjects under 18? no
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排除标准

•1) Medical Conditions
•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.
•Non-squamous subjects with unknown or indeterminate EGFR status are
•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.
•c) Subjects with untreated CNS metastases are excluded.
•d) Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or
•squamous cell skin cancer, superficial bladder cancer, or carcinoma in
•situ of the prostate, cervix, or breast.
•e) Subjects with an active, known or suspected autoimmune disease.
•Subjects 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) Subjects with a condition requiring systemic treatment with either
•corticosteroids (> 10 mg daily prednisone equivalent) or other
•immunosuppressive medications within 14 days of enrollment. Inhaled
•or topical steroids, and adrenal replacement steroid doses < 10 mg daily
•prednisone equivalent, are permitted in the absence of active
•autoimmune disease.
•g) Subjects with interstitial lung disease that is symptomatic or may
•interfere with the detection or management of suspected drug-related
•pulmonary toxicity.
•h) Subjects with serious or uncontrolled medical disorders and any
•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.
•i) Subjects with a known history of a positive test for human
•immunodeficiency virus (HIV) or known acquired immunodeficiency
•syndrome (AIDS). NOTE: Testing for HIV must be performed at sites
•where mandated locally.
•2) Prior/Concomitant Therapy
•a) Prior 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 checkpoint pathways.
•b) Treatment with botanical preparations (eg herbal supplements or
•traditional Chinese medicines) intended for general health support or to
•treat the disease under study within 2 weeks prior to treatment.
•3) Physical and Laboratory Test Findings
•Screening laboratory values that meet the following criteria (using
•CTCAE v4):
•a) WBC < 2000/¿L
•b) Neutrophils < 1500/¿L
•c) Platelets < 100 x 103/¿L
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研究者

发起方

BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

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