A Randomized Phase 3 Comparison of IMO-2125 with Ipilimumab versus Ipilimumab Alone in Subjects with Anti-PD-1 Refractory Melanoma

Idera Pharmaceuticals, Inc.0 个研究点目标入组 470 人开始时间: 2018年3月13日最近更新: 2022年2月7日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Idera Pharmaceuticals, Inc.
入组人数: 470

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

性别: All

入选标准

•1. Subjects must be willing and able to sign the informed consent and comply with the study protocol.
•2. Must be =18 years of age.
•3. Histologically confirmed metastatic melanoma with measurable (by RECIST v1.1), stage III (lymph node or in transit lesions) or stage IVA, IVB, or IVC disease that is accessible for injection. Stage should be determined using the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, Seventh Edition
•4. Confirmed progression during or after treatment with a PD-1 inhibitor (cannot be part of a bi-specific antibody), e.g., nivolumab or pembrolizumab. Confirmed progression is defined as:
•Radiological progression (confirmed at least 4 weeks after the initial scan showing PD); or
•For progression based solely on worsening of non-target or new, non-measurable disease, confirmation by an additional scan at least 4 weeks after the initial scan unless progression is accompanied by correlative symptoms.
•In addition, all the following must hold:
•a) No intervening anti-cancer therapy between the last course of PD-1 inhibitor treatment and the first dose of study treatment is allowed except for local measures (e.g., surgical excision or biopsy, focal radiation therapy).
•b) The interval between last PD-1 inhibitor and start of study treatment should be at least 21 days with no residual anti-PD-1-related immune toxicities in excess of Grade 1 severity.
•c) Subjects who had adjuvant anti-PD-1 treatment are eligible if they have either disease recurrence after the end of adjuvant treatment or on-treatment disease recurrence after =12 weeks of adjuvant treatment.
•d) If subject BRAF mutation status is unknown, before randomization the subject must have BRAF testing performed using an approved assay method.
•e) Patients with BRAF-positive tumor(s) are eligible for the study if they received prior treatment with a BRAF inhibitor (alone or in combination with a MEK inhibitor) or declined targeted therapy.
•5. ECOG Performance Status =1.
•6. Adequate baseline organ function as defined by:
•a) Absolute neutrophil count (ANC) =1.5 x 109/L (1500/mm3)
•b) Platelet count =75 x 109/L (75,000/mm3)
•c) Hemoglobin =8.0 g/dL (4.96 mmol/L)
•d) Serum creatinine =1.5 x upper limit of normal (ULN) or calculated creatinine clearance =60 mL/minute (=Grade 1)
•e) Aspartate aminotransferase (AST) =2.5 x ULN; alanine aminotransferase (ALT) =2.5 x ULN; AST/ALT <5 x ULN if liver involvement (=Grade 1)
•f) Serum bilirubin =1.5 x ULN, except in subjects with Gilbert’s Syndrome who must have a total bilirubin <3 mg/dL (=Grade 1)
•7. Women of childbearing potential (WOCBP) and men must agree to use effective contraceptive methods from screening until at least 90 days after the last dose of either ipilimumab or IMO-2125, whichever is later.
•8. WOCBP must have a negative pregnancy test (serum or urine) according to the Schedule of Evaluations described in the study Protocol.
•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 206
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 248

排除标准

•1. Ocular melanoma.
•2. Prior therapy with a TLR agonist, excluding topical agents.
•3. Prior ipilimumab with the exception of adjuvant treatment completed =6 months prior to enrollment.
•4. Systemic treatment with IFN-a within the previous 6 months.
•5. Known hypersensitivity to any oligodeoxynucleotide.
•6. Active autoimmune disease requiring disease modifying therapy at the time of screening.
•7. Subjects with a requirement for receiving more than physiologic doses of systemic steroids (>10 mg/day of prednisone or equivalent) for the 2 weeks preceding start of study treatment.
•8. Subjects with another primary malignancy that has not been in remission for at least 3 years with the exception of non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic).
•9. Active systemic infections requiring antibiotics.
•10. Known active, hepatitis A, B, or C infection.
•11. Known diagnosis of human immunodeficiency virus (HIV) infection.
•12. Women who are pregnant or breast-feeding.
•13. Prior anaphylactic or other severe infusion reaction associated with human antibody administration that cannot be managed with standard supportive measures.
•14. Presence of known central nervous system, meningeal, or epidural metastatic disease. However, subjects with known brain metastases are allowed if the brain metastases are stable for =4 weeks before the first dose of study treatment. Stable is defined as neurological symptoms not present or resolved to baseline, no radiologic evidence of progression, and steroid requirement of prednisone =10 mg/day or equivalent.
•15. Impaired cardiac function or clinically significant cardiac disease.

研究者

发起方

Idera Pharmaceuticals, Inc.

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