EUCTR2011-004501-24-GB进行中（未招募）1 期
Phase II study to evaluate the safety, tolerability and efficacy of CT-011 administered intravenously to patients with metastaticmelanoma - Not available
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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. Patients with histologically or cytologically documented diagnosis of advanced/inoperable metastatic melanoma of skin, mucosal, or unknown origin are eligible, provided they fulfill the following conditions:
- •2. Patient age is 18 years or older with measurable (at least 1 cm) metastatic disease;
- •3. Stage IV (M1a,b,c) that is clearly progressive since last therapy.
- •4. They have ECOG performance status of 0 or 1.
- •5. Patients with a maximum of 3 prior lines of treatment for metastatic disease including those who have received prior approved or investigational treatments,
- •those who are not deemed appropriate for or who have refused treatment with such agents, or those for whom such treatments are deemed not in their immediate best interest can be enrolled.
- •6. Expected survival of at least 4 months
- •7. Must be at least 21 days since surgery and/or radiation therapy and at least 4 weeks since last treatment with either approved standard therapy or investigational therapies including cytotoxic chemotherapy, interferon alpha or molecularly targeted therapies, and at least 6 weeks from HD IL-2 or ipilimumab
- •therapy and have adequately recovered (to at least Grade 1 level) from adverse effects of these therapies and have evidence of documented disease progression.
- •8. Values of laboratory tests required for registration: WBC: 2000/uL or greater,
- •lymphocytes 1.0X 109/L or greater, ANC: 1000/uL or greater, hemoglobin: 9 g/dL
- •or greater, creatinine: without liver metastasis or, mg/dL, LDH 9. No significant intercurrent illness such as a serious infection which requires
- •intravenous antibiotics. No active or chronic infection with HIV, Hepatitis B or
- •Hepatitis C.
- •10. Patients that received interferon, GM-CSF, or experimental cancer vaccines for melanoma in the adjuvant setting are eligible. Prior radiation therapy for metastatic melanoma is permitted provided the patient has un-irradiated metastatic sites for response evaluation and any toxicity has returned to Grade 1
- •or baseline (patients with mild lymphedema following radiotherapy are allowed).
- •11. Patients with brain metastases should be at least 4 weeks from craniotomy and resection or stereotactic radiosurgery. MRI/CT of the brain performed within 2 weeks from screening fails to show new metastases and they are off of steroids for at least 2 weeks. Patients previously treated with whole brain radiotherapy are eligible if they are without tumor progression in the brain at least 8 weeks from completion of radiotherapy and are asymptomatic and off of steroids for at least 2 weeks.
- •12. Fertile patients and/or their partners must declare simultaneous use of two forms of birth control during the treatment period and up to 4 months after the last treatment of CT-011. The decision for appropriate methods to prevent pregnancy should be determined by discussions between the investigator and the study subject.
- •13. Ability and willingness to give informed consent.
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Patients with uveal melanoma.
- •2. Active autoimmune disease, symptoms or conditions except for vitiligo, type I diabetes, treated thyroiditis, asymptomatic laboratory evidence of autoimmune disease (eg: + ANA, +RF, antithyroglobulin antibodies) or mild arthritis requiring no therapy or manageable with NSAIDs.
- •3. Known major immunodeficiency
- •4. Unresolved immune related adverse events following prior biological therapy
- •5. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study agent and anti-CTLA4 therapy given within 6 weeks prior to first dosing.
- •6. Prior anti PD-1, anti PD-L1 or PD-L2 therapy.
- •7. More than 3 prior lines of treatment for metastatic melanoma including approved and investigational treatments. Questionable situations should be discussed with the Study Medical Monitor.
- •8. Metastases associated with active bleeding expected to require transfusion in the next 3 months
- •9. Patients with New York Heart Association class II, III or IV disease or arrhythmia requiring treatment. Borderline cases must be discussed with the Study Medical Monitor.
- •10. Patients with clinically significant impairment of pulmonary function due to chronic bronchitis or chronic obstructive pulmonary disease (COPD). History of major lung resection or major underlying chronic bronchitis, COPD or restrictive
- •lung disease should be evaluated with pulmonary function tests: Patients with the FEV1 <1.5 liters or <50% or FVC <50% of predicted should be excluded.
- •Borderline cases must be discussed with the Study Medical Monitor.
- •11. Patients on corticosteroids (inhaled or oral steroids for treating mild asthma treated by a low dose at a maximum of 500 micrograms per day for up to 10 consecutive days or allergies or topical steroids for localized -< 5% of body surface area- dermatitis are allowed) or any other type of immunosuppressive
- •agent (e.g., methotrexate, chloroquine, azathioprine, cyclophosphamide)
- •12. Patients with history of second malignancies are eligible provided that they have been free of recurrence from second malignancy for at least 5 years, except that the following are allowed: basal cell cancer (BCCa) or squamous cell cancer (SCCa) of the skin, or carcinoma in situ of the breast or cervix or localized
- •prostate cancer detected via biopsy only and being treated with watchful waiting”. Each case must be discussed with the Study Medical Monitor prior to registration.
- •13. Patients with symptomatic uncontrolled brain metastasis that is associated with significant brain edema requiring steroid therapy. Patients with spinal cord metastasis or meningeal carcinomatosis.
- •14. Patients who are ineligible for imaging by CT and MRI due to suspected or known allergy to contrasting agents or patients who are ineligible for CT scan and have an implanted pacemaker (thus ineligible for MRI).
- •15. Women of child bearing potential who are pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) done within 72 hours of first dosing or nursing.
- •16. Any condition that, in the clinical judgment of the treating physician, is likely to prevent the patient from complying with any aspect of the protocol or that may put the patient at unacceptable risk.
研究者
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