EUCTR2021-004453-23-BE进行中（未招募）1 期
A PHASE 3 TRIAL OF FIANLIMAB (REGN3767, ANTI-LAG-3) + CEMIPLIMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,590
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. Age =12 years on the date of providing informed consent. Note: Patients who are <18 years will be included in the territories, where accepted, per local laws and regulations.
- •2. Patients with histologically confirmed unresectable Stage III and Stage IV (metastatic) melanoma (AJCC, 8th revised edition) who have not received prior systemic therapy for advanced unresectable disease.
- •a. Patients who received adjuvant and/or neoadjuvant systemic therapies are eligible if they did not have evidence of progression or recurrence of disease and/or discontinued due to occurrence of unmanageable irAEs = grade 3 (with the exclusion of endocrinopathies which are fully controlled by hormone replacement) while on such therapies. Also, patients must have had a treatment-free and disease-free interval of >6 months.
- •b. Patients with acral and mucosal melanomas are eligible. Accrual will be limited to 10% of the total population.
- •3. Measurable disease per RECIST v1.1
- •a. Previously irradiated lesions can only be counted as target lesions if they have been demonstrated to progress and no other target lesion is available
- •b. Cutaneous lesions should be evaluated as non-target lesions
- •4. Performance status:
- •a) For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- •b) For pediatric patients: Karnofsky performance status =70 (patients =16 years) or Lansky performance status =70 (patients <16 years)
- •5. Anticipated life expectancy of at least 3 months.
- •Please note other protocol-defined Inclusion criteria apply
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 6
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1290
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 294
排除标准
- •Medical conditions:
- •1. Uveal melanoma
- •2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
- •3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.
- •4. Unknown BRAF V600 mutation status. Patients with BRAF-mutated melanoma who present with symptoms of rapidly progressive disease and are considered by Investigator’s assessment as likely to benefit from upfront treatment with BRAF/MEK-inhibitors should not be enrolled in the study.
- •Prior/concomitant therapy:
- •5. Systemic immune suppression:
- •a. Use of immunosuppressive doses of corticosteroids (=10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication. Physiologic replacement doses are allowed up to and including 10mg of prednisone/day or equivalent. Inhaled or topical steroids are permitted, if they are not for treatment of an autoimmune disorder.
- •b. Other clinically relevant forms of systemic immune suppression.
- •6. Treatment with other anti-cancer therapy including immuno- therapy, chemotherapy, major surgery or biological therapy within 21 days prior to the first dose of trial treatment. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
- •Other comorbidities:
- •7. History or current evidence of significant (CTCAE grade =2) local or systemic infection (eg, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 14 days prior to the first dose of trial medication
- •8. Active or untreated brain metastases or spinal cord compression. Patients with leptomeningeal disease are excluded. Patients with known brain metastases are eligible if they:
- •a. received radiotherapy or another appropriate standard therapy for the brain metastases,
- •b. have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment) for at least 14 days prior to enrollment.
- •c. did not require immunosuppressive doses of corticosteroids therapy (>10mg of prednisone per day or equivalent) in the 14 days prior to enrollment.
- •Note: Patients who are asymptomatic single untreated brain metastasis <10 mm in size are eligible.
- •9. Adolescent patients (=12 to <18 years old) with body weight <40 kg.
- •Other protocol-defined Exclusion criteria apply
研究者
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