A Phase 2/3 (Adaptive Design) Study of the Concomitant Administration of Indoximod or Placebo plus Pembrolizumab or Nivolumab in Adult Patients with Unresectable Stage III or Stage IV Malignant Melanoma

ewLink Genetics Corporation0 个研究点目标入组 650 人开始时间: 2017年11月29日最近更新: 2019年6月30日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 650

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

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

入选标准

•Participant must be 18 years and older (adults and seniors) at the time of signing the
•informed consent.
•1. Have histologically- or cytologically-confirmed unresectable stage III or stage IV melanoma, as per AJCC (8th Edition) staging system not amenable to local therapy
•2. Subject must have at least one radiologically measurable lesion as per RECIST 1.1 (Appendix 7: RECIST 1.1 Guideline of the protocol) defined as a lesion that is 10mm in longest diameter or lymph node that is 15mm in short axis imaged by computed tomography (CT) scan or magnetic resonance imaging (MRI).
•3. Have been untreated for advanced or metastatic disease except as follows
•a) BRAF V600 mutant melanoma may have received standard of care targeted therapy (e.g. BRAF/MEK inhibitor, alone or in combination)
•b) Prior adjuvant or neoadjuvant melanoma therapy is permitted if it was completed at least 4 weeks before randomization and all related adverse events have either returned to baseline or stabilized for non-immune therapy based regimens.
•c) Prior adjuvant therapy containing immunotherapy such as interferon or anti-CTLA-4 therapy will only be permitted if relapse did not occur during treatment or within 6 months of treatment discontinuation.
•d) Prior anti-PD-1, anti-PD-L1, or IDO1 inhibitors are excluded.
•4. Have documentation of V600-activating BRAF mutation status or consent to BRAF V600 mutation testing during the screening period.
•5. Must collect and submit available archival tumor tissue. If no archival tumor tissue is available, subject will not be excluded.
•6. ECOG performance status 0 or 1
•7. Patient has adequate bone marrow and organ function as defined by the following laboratory values: Absolute Neutrophil Count (ANC) = 1,500 cells/µL (1.5 x109/L), without growth factor support; Platelets = 100,000 cells/µL (100 x109 cells/L), without growth factor support; Hemoglobin = 9.0 g/dL (90g/L); INR = 2 x ULN
•8. Any hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, hypocalcemia must be = Grade 1 per CTCAE Version 4.03
•9. Serum Creatinine = 1.5 x ULN, or creatinine clearance (Ccr) > 60 mL/min based on the Cockcroft-Gault equation.
•10. Total bilirubin, amylase and lipase = 1.5 x ULN (in patients with known Gilbert Syndrome, total bilirubin = 3 x ULN, with direct bilirubin = 1.5 x ULN)
•11. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) = 3 x ULN, (in subjects with liver metastases, < 5 x ULN)
•12. Serum Albumin = 3 g/dL
•13. Patients must have normal pituitary function as determined by investigator clinical judgment.
•14. HIV positive patients who are stable on antiretroviral medication (ART). Patients stable on ART are defined as those who have received ART for at least 1 year with no adverse drug reactions requiring regular monitoring, no current illnesses or pregnancy, a good understanding of lifelong adherence, and evidence of treatment success. Treatment success is defined as two consecutive undetectable viral load measures or, in the absence of viral load monitoring, rising CD4 counts or CD4 counts above 200 cells/mm3 and an objective
•adherence measure.
•15. Patients with k

排除标准

•1. Has Ocular Melanoma
•2. Has received prior systemic treatment for unresectable or metastatic melanoma (except
•BRAF directed therapy as noted in inclusion criteria #3).
•3. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
•IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways
•other than anti-CTLA-4 which is permitted in the adjuvant setting.
•4. Has received prior adjuvant therapy, monoclonal antibody or an investigational agent or
•device within 4 weeks or 5 half-lives (whichever is longer) before study Day 1 or not
•recovered (Grade 1 or at baseline) from AEs due to previously administered agents.
•Exception to this rule would be use of bisphosphonates, which is not excluded.
•5. Has received prior radiotherapy within 2 weeks of therapy. Subjects must have recovered
•from all radiation-related toxicities, not require corticosteroids, and not have had radiation
•pneumonitis. A 1-week washout is permitted for palliative radiation (2 weeks of RT) to
•non-CNS disease.
•6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in
•dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
•immunosuppressive therapy within 7 days before the first dose of study treatment.
•7. Has known active, uncontrolled brain or CNS metastases and/or carcinomatous meningitis.
•8. History or presence of an abnormal electrocardiogram (ECG) that, in the investigator’s
•opinion, is clinically meaningful. Screening QTc interval > 480 msec is excluded
•(corrected by Fredericia or Bazett formula). In the event that a single QTc is > 480 msecs,
•the subject may enroll if the average QTc for the 3 ECGs is < 480 msecs.
•9. Has clinically significant cardiac disease, including unstable angina, acute myocardial
•infarction within 6 months from first dose of study drug administration, New York Heart
•Association Class III or IV congestion heart failure (see Appendix 6), and arrhythmia
•requiring therapy. Medically controlled arrhythmia would be permitted.
•10. Has history of allergic reactions attributed to compounds of similar chemical or biologic
•composition to pembrolizumab, nivolumab or tryptophan-containing substances.
•11. Is pregnant or breast-feeding or expecting to conceive or father children within the
•projected duration of the study, starting with the screening visit through minimum of
•4 months (for those who receive pembrolizumab) and a minimum of 5 months (for those
•who receive nivolumab) after the last dose of study treatment.
•12. Patients who have active, chronic, or on active treatment for Hep B or Hep C are excluded.
•13. Any other cancer, unless the patient has been disease-free for = 5 years (except treated and
•cured basal-cell or squamous-cell skin cancer, superficial bladder cancer, or treated
•carcinoma in situ of the cervix, breast, or bladder and treated localized prostate cancer with

研究者

发起方

ewLink Genetics Corporation

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