EUCTR2020-005647-24-NO进行中（未招募）1 期
A phase II, open label, randomised trial of ipilimumab and nivolumab with concurrent intracranial stereotactic radiotherapy versus ipilimumab and nivolumab alone in patients with melanoma brain metastases. - Anti-PD 1 Brain Collaboration + Radiotherapy Extension: The ABC-X Study
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
- 218
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. Female or male patients, =18 years of age.
- •2. Signed, written, informed consent.
- •3. AJCC Stage IV [any T, any N, M1d, M1d(0) or M1d(1)] histologically confirmed cutaneous, acral or mucosal melanoma or unknown primary melanoma with metastases to the brain that are considered unresectable.
- •Patients must have at least 1 radiological definitive brain metastasis that is = 5mm and =40mm, measurable per RECIST version 1.1 guidelines (modified for brain metastases, in which up to five lesions can be selected as target lesions in addition to extracranial lesions).
- •There is no upper limit restriction to the number of brain metastases, provided the remaining eligibility criteria are met.
- •4. The BRAF mutation status must be available prior to randomisation.
- •5. The radiation oncologist should consider ALL intracranial melanoma lesions amenable to stereotactic radiosurgery/therapy over whole brain including the SRS treatment of intracranial lesions =5mm in diameter.
- •Patients for whom there is a definite and immediate indication for radiotherapy (e.g. rapidly progressing disease with associated clinical signs and /or symptoms) should not be considered for enrolment.
- •The presence of small brain metastases - =5mm in diameter – in addition to a qualifying lesion = 5mm and =40mm must be considered treatable with SRS. If there is a clinical reason or MDT recommendation or a technical reason for not treating these lesions, the patient is NOT eligible for this study.
- •6. Brain metastases must be untreated with any modality of radiotherapy.
- •Previous surgery for melanoma brain metastases is permitted.
- •Prior radiotherapy to any extracranial lesions is permitted
- •7. Brain metastases must be untreated with any form of systemic treatment.
- •Systemic treatment for extracranial disease is permitted if given in the neoadjuvant or adjuvant settings and only if brain metastases were confirmed absent with radiological evidence throughout systemic treatment.
- •The presenting diagnosis of brain metastases at the time of enrolment in this study must have occurred a minimum of 6 months after stopping neoadjuvant or adjuvant systemic therapy for extracranial disease
- •Prior anti-PD1, anti PD-L1, anti-CTLA-4, BRAF / MEK inhibitors or clinical trial agents are acceptable in the setting of neoadjuvant or adjuvant treatment for extracranial disease.
- •8. Asymptomatic from brain metastases at the time of study enrolment without corticosteroids, analgesia or any other treatment for the management of neurological symptoms or as prophylactic treatment (except for antiepileptics prescribed for any reason, provided the patient is asymptomatic).
- •Resolved neurological symptoms are permitted if complete resolution, without any intervention, has been sustained for a minimum of 7 days prior to randomisation.
- •9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- •10. A life expectancy of > 30 days.
- •11. Able to undergo MRI with Gadolinium contrast agent. CT of the brain is not an acceptable alternative should patients be unable to safely undergo a contrast MRI.
- •12. Adequate haematological, hepatic and renal organ function as defined by:
- •a. White cell count = 2.0 × 109/L
- •b. Neutrophil count = 1.5 × 109/L
- •c. Haemoglobin = 90 g/L
- •d. Platelet count = 100 x 109/L
- •e. Total bilirubin = 1.5 x ULN
- •f. Alanine transaminase = 3.0 x ULN
- •g. Aspartate aminotransferase = 3.0 x ULN
- •h. Serum creatinine = 1.5 x the upper limit of normal (ULN). If serum creatinine is > 1.
排除标准
- •1. Patients whose intracranial disease changes between the diagnostic MRI scan and the baseline / SRS planning MRI scan and who are no longer suitable for SRS and / or require a specific alternative treatment outside of this protocol.
- •2. Any melanoma brain metastasis greater than 40mm diameter.
- •3. Evidence of leptomeningeal disease, with the exception of pathological findings seen at a previous resection of brain disease, but with no evidence of leptomeningeal disease elsewhere at the time of resection or at study entry.
- •4. History of, or current ocular (both uveal and conjunctival) melanoma (patients with mucosal and acral melanoma are eligible).
- •5. Symptoms from brain metastases at the time of study enrolment or a requirement for corticosteroids, analgesia or any other treatment for the management of neurological symptoms.
- •6. Prior radiotherapy to the brain (prior surgery permitted).
- •7. Prior systemic drug therapy for melanoma, unless given in the neoadjuvant or adjuvant setting for extracranial disease only, completed = 6 months before enrolment in this study and if administered with radiological proof of the absence of brain metastases.
- •8. Patients with active, known or suspected autoimmune disease. Patients with the following conditions are permitted to enrol:
- •a. Vitiligo
- •b. Type I diabetes mellitus
- •c. Residual hypothyroidism due to an autoimmune condition only requiring hormone replacement
- •d. Psoriasis that does not require systemic treatment
- •e. Autoimmune conditions not expected to recur in the absence of an external trigger.
- •9. Current systemic treatment with corticosteroids, or within 7 days of randomisation, with the exception of prednisone at non-immunosuppressive doses of = 10 mg/day (or equivalent, e.g. prednisone 10mg = dexamethasone 1.6mg = hydrocortisone 40mg). Patients with the following circumstances are permitted to enrol:
- •a. Past treatment for non-neurological symptoms allowed, if this was ceased 7 days prior to randomisation
- •b. Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if the patient is on a stable dose
- •c. Non-absorbed intra-articular steroid injections.
- •During the study, treatment with systemic corticosteroids is permitted during radiotherapy if the patient experiences radiation related symptoms but this should be tapered per standard clinical practice as soon as possible to = 10mg/day and before the next infusion of study drug(s) is due. This also refers to steroids for drug related signs or symptoms.
- •10. Any active infection requiring treatment.
- •11. A history of interstitial lung disease.
- •12. A known history of another malignancy or concurrent malignancy unless the patient is disease-free for a minimum of 1 year, is completely treated and is at low-risk of recurrence. The time requirement does not apply for patients with successful definitive resection or curative treatment of:
- •a. Non-melanoma skin cancer (e.g. basal cell or squamous cell carcinoma of the skin),
- •b. Superficial bladder cancer,
- •c. In situ carcinoma of the cervix,
- •d. In situ breast cancer,
- •e. Atypical melanocytic hyperplasia or melanoma in situ
- •f. Other in situ carcinomas,
- •13. Serious or unstable pre-existing medical conditions or other conditions that could interfere with the patient’s safety, consent, or compliance.
- •14. Pregnant or breastfeeding females.
- •15. Administration of any form of live vaccine within 30 days of starting the trial and during the trial. Administrati
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