NL-OMON52200招募中2 期
Conversion of unresponsiveness to immunotherapy by Fecal Microbiota Transplantation in patients with metastatic melanoma and non-melanoma skin cancer: a randomized phase Ib/IIa trial - FMT to convert response to immunotherapy
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 28 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 28
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
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patients should be 18 years or older
- •- Patients have pathologically confirmed advanced stage cutaneous melanoma
- •cutaneous squamous cell carcinoma or Merkel cell carcinoma (stage III or IV)
- •requiring systemic treatment with anti-PD-(L)1
- •- In case of melanoma patients with stage IV disease, only patients
- •with limited disease progression without immediate clinical risks of delaying
- •other treatment options, based on the judgment of the treating physician, are
- •- Patients have confirmed disease progression (>=20% increase according to
- •RECIST 1.1 or measurable recurrence under adjuvant treatment) on two
- •consecutive scans with a four week interval while on anti-PD-1 treatment, of
- •which the second scan has to be performed within 3 weeks prior to signing
- •informed consent.
- •- Patients must have measurable disease per RECIST 1.1 criteria
- •- Patients have an ECOG performance status of 0-1
- •- Patients have a life expectancy of >3 months
- •- Patients have adequate organ function as determined by standard-of-care
- •pre-checkpoint inhibitor infusion lab (including serum ALAT/ASAT less than
- •three times the upper limit of normal (ULN); serum creatinine clearance
- •50ml/min or higher; total bilirubin less than or equal to 20 micromol/L, except
- •in patients with Gilbert*s Syndrome who must have a total bilirubin less than
- •50 micromol/L)
- •- Patients have an LDH level of <2x times ULN
- •- Patients of both genders must be willing to use a highly effective method of
- •birth control during treatment
- •- Patients must be able to understand and sign the Informed Consent document
排除标准
- •- Patients with acral, uveal or mucosal melanoma.
- •- Patients with non-cutaneous squamous cell carcinoma
- •- Patients who have received systemic treatment for their melanoma or
- •non-melanoma skin cancer other than anti-PD-(L)1 treatment.
- •- Stage IV melanoma patients with rapid or invasive disease progression
- •necessitating an immediate switch to a proven effective treatment, as judged by
- •the treating physician.
- •- Patients with autoimmune diseases: patients with a history of inflammatory
- •bowel disease, including ulcerative colitis and Crohn*s disease, are excluded
- •from this study (except Hashimoto thyroiditis, vitiligo, history of psoriasis,
- •but no active disease)
- •- Patients with any grade 3 or 4 immune-related adverse events still requiring
- •active immunosuppressive medication (prednisone <=10mg/day or equivalent are
- •permitted), apart from endocrinopathies that are stable under hormone
- •replacement therapy. Patients who had developed grade 3-4 immune related
- •toxicity, which has reverted to grade I with immunosuppressive drugs and who
- •are off immunosuppression at least two weeks prior to enrollment are eligible
- •(prednisone <=10mg/day or equivalent are permitted.
- •- Patients with active or symptomatic brain metastasis or LM metastasis (brain
- •metastases treated with radiotherapy, that are inactive and asymptomatic are
- •- Patients with an elevated LDH level.
- •- Patients that have undergone major gastric/esophageal/bowel surgery (like
- •Wipple, subtotal colectomy)
- •- Severe food allergy (e.g. nuts, shellfish)
- •- Patients with a swallowing disorder or expected bowel passage problems
- •(ileus, fistulas, perforation).
- •- Severe dysphagia with incapability of swallowing 1 liter of bowel lavage.
- •- Patients with a life expectancy of less than three months
- •- Patients with severe cardiac or pulmonary comorbidities (per judgement of the
- •investigator)
- •- Women who are pregnant or breastfeeding
- •- Patients with any active systemic infections, coagulation disorders or other
- •active major medical illnesses
- •- Patients with other malignancies, except adequately treated and a
- •cancer-related life-expectancy of more than 5 years.
- •- Patients who received treatment with antibiotics in the three months prior to
- •study enrolment, or patients we are expected to receive systemic antibiotics
- •during the course of this study
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