EUCTR2018-004778-81-DE进行中（未招募）1 期
A phase II study of immunotherapy with durvalumab (MEDI4736) or durvalumab and tremelimumab, both combined with Y-90 SIRT therapy in patients with advanced stage intrahepatic biliary tract cancer (BTC) scheduled to receive Y-90 SIRT therapy as standard of care - IMMUWHY
Institut für Klinische Krebsforschung IKF GmbH0 个研究点目标入组 50 人开始时间: 2019年7月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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.Fully-informed written consent and locally required authorization (European Union [EU]: General Data Privacy Regulation (GDPR)) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
- •2.Age = 18 years.
- •3.Histologically documented diagnosis of locally-advanced OR limited metasized intrahepatic, BTC not amenable to curative treatment (tumor resection or ablation), specified as
- •Tumor being confined to the liver or
- •In case of presence of extrahepatic lesions, metastasis must be stable AND of limited extent* AND patient must have a potential benefit from study participation in comparison to standard of care systemic therapy per local tumor board evaluation.
- •*Limited extent is defined in this protocol as presence of
- •oEITHER =3 malignant extrahepatic lymph nodes (short axis diameter =3cm)
- •oOR metastatic lesions in one organ other than liver (if only single lesion is present diameter MUST be < 3cm; if up to 3 lesions in one organ each lesion MUST be = 1cm).
- •oPresence of peritoneal or brain metastatsis excludes patients from study participation
- •4.Has been considered candidate for standard-of-care Y-90 SIRT therapy per Investigator decision and after prior consultation with the tumor board if available at site and does not display contraindications against SIRT.
- •Contraindications against SIRT would be
- •ohepatic tumor load > 50%
- •oAny Gastrointestinal deposition that cannot be corrected via angiographic techniques
- •oirreversibly elevated serum bilirubin
- •orenal insufficiency
- •oincreased pulmonary shunt fraction being able to deliver > 16.5 mCi to the lungs
- •ogastrointestinal ulceration
- •ohepatic dysfunction
- •obiliary complications
- •oportal hypertension
- •ovascular injury and lymphopenia.
- •5.Performance status (PS) = 1 (ECOG scale).
- •6.Body weight >30 kg
- •7.At least one measurable site of disease as defined by RECIST 1.1 criteria.
- •8.Adequate bone marrow and renal function including the following:
- •oHemoglobin = 9.0 g/dL;
- •oabsolute neutrophil count = 1.5 x 103/L;
- •oplatelets =100x 109 /L;
- •oCreatinine = 1.5 x upper normal limit.
- •oCalculated creatinine clearance =40 mL/min as determined by the Cockcroft-Gault equation
- •9.Adequate hepatic function (with stenting for any obstruction, if required) including the following:
- •o Serum bilirubin = 1.5 x institutional upper limit of normal (ULN);
- •o AST (SGOT) / ALT (SGPT) = 2.5x institutional ULN
- •(NOTE: if liver metastases are present AST / ALT must be = 5x institutional ULN;
- •oprothrombin time ? 60%;
- •oalbumin ? 30 g/L.
- •10.Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
- •11.Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- •oWomen <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- •oWomen =50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more
排除标准
- •1.Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study, or during the follow-up period of an interventional study.
- •2.Participation in another clinical study with an investigational product within 21 days prior to the first dose of the study treatment.
- •3.Prior immunotherapy or use of other investigational agents, including prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T-lymphocyte associated antigen-4 (anti-CTLA-4) antibody, therapeutic cancer vaccines.
- •4. Presence of peritoneal carcinomatosis or brain metastases.
- •5.Any unresolved toxicity NCI CTCAE Grade = 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- •oPatients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab and tremelimumab may be included only after consultation with the Coordinating Investigator.
- •6.Any concurrent chemotherapy, investigational product (IP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (eg, hormone replacement therapy) is acceptable.
- •7.Prior radiotherapy treatment before the first dose of any study drug.
- •8.Major surgery (as defined by the Investigator) within 4 weeks prior to enrollment into the study; patients must have recovered from effects of any major surgery. Note: Local non-major surgery for palliative intent (e.g. surgery of isolated lesions, per-cutaneous biliary drainage or biliary stenting) is acceptable.
- •9.Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g. colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis]. The following are exceptions to this criterion:
- •oPatients with vitiligo or alopecia
- •oPatients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
- •oAny chronic skin condition that does not require systemic therapy
- •oPatients without active disease in the last 5 years may be included but only after consultation with the study physician
- •10.Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, , serious active, uncontrolled, gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
- •11.History of non-infectious pneumonitis requiring steroids, or patients with Grade = 2 pneumonitis.
- •12.History of another primary malignancy except for:
- •oMalignancy treated with curative intent and with no known active disease = 5 years before the first dose of IP and of low potential risk for recurrence
- •oAdequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •oAdequately treated carcinoma in situ without evidence of disease
- •13.History of leptomeningeal carcinomatosis
- •14.Brain metastases or spinal cor
研究者
相似试验
已完成
2 期
ADJUBIL - A Phase II study of immunotherapy with durvalumab and tremelimumab in combination with capecitabine or without capecitabine in ADJUvant situation for BILiary tract cancer2024-511847-24-00Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH40
招募中
2 期
IMMUWIN - A Phase II study of immunotherapy with durvalumab (MEDI4736) and tremelimumab in combination with Y-90 SIRT
for intermediate stage HCC2024-513950-32-00Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH55
已完成
不适用
A phase Ib study of Durvalumab in combination with carbon-ion radiotherapy and weekly cisplatin for patients with locally advanced cervical cancer. An additional study for immunological prognostic factorsCervical cancerJPRN-UMIN000044470ational Institutes for Quantum and Radiological Science and Technology10
已完成
2 期
A Phase II Study of Durvalumab and Tremelimumab in combination with Neoadjuvant Carboplatin and Paclitaxel in newly diagnosed women with advanced high grade Serous Ovarian, Fallopian Tube and Peritoneal Cancers iPRIME”.Fallopian tube cancerPeritoneal cancerCancer - Ovarian and primary peritonealOvarian cancerACTRN12618000109202Australia New Zealand Gynaecological Oncology Group (ANZGOG)75
进行中（未招募）
1 期
Treatment of patients with HIV-1 and advanced solid tumors with Durvalumabadvanced solid tumors in HIV-1 infected patientsEUCTR2016-004524-38-ESSpanish Lung Cancer Group (Grupo Español de Cáncer de Pulmón)20