EUCTR2020-003921-51-FR招募中1 期
Phase 2 single arm clinical study to evaluate the efficacy and safety of intratumoral administration of BO-112 in combination with pembrolizumab in subjects that have progressed on anti-PD-1-based therapy in refractory unresectable malignant melanoma stage III or IV
Highlight Therapeutics0 个研究点目标入组 40 人开始时间: 2020年11月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Be willing and able to give written informed consent for the study.
- •2.Be > or = 18 years of age on day of signing informed consent.
- •3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •4.Histologically confirmed diagnosis of cutaneous or mucosal melanoma.
- •5.Known BRAF status.
- •6.Have unresectable stage III or stage IV melanoma. Patients must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies.
- •7.Anti-PD-1-based therapy should have been the last line of systemic therapy as part of first line treatment. Prior treatment either in neo or adjuvant setting is allowed.
- •8.At least one tumoral lesion that is RECIST 1.1 measurable and amenable for IT injection.
- •9.At least one accessible tumor lesion that is amenable to weekly injection. If liver is a site of injection, presence of at least one additional tumor lesion outside the liver amenable for injection.
- •10.Willingness to provide biological samples required for the duration of the study including a fresh tumor biopsy sample. NOTE: If possible, the biopsied lesion should be a non-target lesion.
- •11.Adequate hematologic and organ function
- •12.Female patient of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the injection of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •13.Female patients who are not pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
- •14.Patients should be informed that taking the study medication may involve unknown risks to the fetus (unborn baby) if pregnancy were to occur during the study. In order to participate in the study, they must adhere to the contraception requirement (described above). If there is any question that a patient will not reliably comply with the requirements for contraception, that patient should not be entered into the study.
- •15.Male patients should agree to use an adequate method of contraception from the beginning of the study through 120 days after receiving the study medication.
- •16.In countries where human immunodeficiency virus (HIV) positive patients can be included, HIV infected participants must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease
- •17.Able and willing to comply with study and follow-up procedures.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Uveal melanoma.
- •2.Prior grade 3-4 irAE due to immune checkpoint inhibitors requiring systemic steroids for more than 2 weeks.
- •3.Prior intra-tumoral treatments.
- •4.If a liver lesion is the site of injection:
- •a.macroscopic tumor infiltration into the main portal vein, hepatic vein or vena cava;
- •b.portal vein thrombosis;
- •c.prior embolization of liver lesions;
- •d.radiofrequency, cryotherapy or microwave ablation in the last 6 months;
- •e.Child-Pugh B or C;
- •f.AST, ALT and bilirubin greater than normal limits.
- •5.Contraindications to tumor biopsy and injections of the hepatic metastasis(es), such as coagulopathy, therapeutic dose anticoagulant treatment and treatment with long-acting agents such as clopidogrel which cannot be safely stopped.
- •6.Chemotherapy or biological cancer therapy within 4 weeks prior to the first dose of study treatment. Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to < or = Grade 1 or baseline. Participants with < or = Grade 2 neuropathy may be eligible.
- •7.Palliative radiotherapy within 1 week of start of study treatment. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- •8.Clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- •9.History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
- •10.Allergy to BO-112 and/or any of its excipients.
- •11.Allergy to pembrolizumab and/or any of its excipients.
- •12.Active infection requiring systemic therapy.
- •13.History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- •14.Active autoimmune disease that required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- •15.Receiving systemic immunosuppressive therapy within 28 days before enrolment with the exceptions of intranasal, topical, and inhaled corticosteroids or oral corticosteroids at physiological doses not exceeding 10 mg/day of prednisone or equivalent.
- •16.HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
- •17.Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV). Patients who are hepatitis B surface antigen negative and HBV viral DNA negative are eligible.
- •a.Patients who had HBV but have received an antiviral treatment and show non-detectable viral DNA for 6 months are eligible.
- •b.Patients who are seropositive because of HBV vaccine are eligible.
- •18.Seropositive for and with active viral infection with hepatitis C virus (HCV).
- •a.Patients who had HCV but have received an antiviral treatment and show no detectable HCV viral DNA for 6 months are eligible.
- •19.Has received a live vaccine within 28 days prior to th
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