ISRCTN11391038进行中（未招募）3 期
IDE196 (DAROVASERTIB) in combination with crizotinib versus investigator’s choice of treatment as first-line therapy in HLA-A2 negative metastatic uveal melanoma
BC Late Stage (UK)0 个研究点目标入组 380 人开始时间: 2023年12月13日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 380
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
- •Participants must meet all of the following inclusion criteria:
- •1. Must be at least 18 years of age.
- •2. Is able to provide written, informed consent before initiation of any study related-procedures, and is able, in the opinion of the investigator, to comply with all the requirements of the study.
- •3. Has histological or cytological confirmed UM with metastatic disease
- •4. HLA-A*02:01 negative
- •5. Must meet the following criteria related to prior treatment:
- •5.1. No prior systemic therapy in the metastatic or advanced setting including chemotherapy, immunotherapy, or targeted therapy
- •5.2. No prior regional, liver-directed therapy including chemotherapy, radiotherapy, or embolization
- •5.3. Prior ablations or surgical resection of oligometastatic disease are allowed
- •5.4. Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in participants with localized disease and a minimum of 4 weeks (28 days) has elapsed between the end of neoadjuvant/adjuvant treatment and the start of study treatment.
- •5.4.1. Participants who have received a combination of anti-PD(L)1 plus anti-CTLA-4 as prior neoadjuvant/adjuvant treatment should not receive ipilimumab + nivolumab as Investigator’s Choice therapy
- •5.4.2. Participants who have received an anti-PD(L)1 agent as prior neoadjuvant/adjuvant treatment should not receive pembrolizumab as Investigator’s Choice therapy
- •5.4.3. Participants who have received a dacarbazine-containing regimen as prior neoadjuvant/adjuvant treatment should not receive dacarbazine as Investigator’s Choice therapy
- •6. Has a representative archival metastatic tumour specimen in paraffin blocks with an associated pathology report or a minimum of 16 formalin-fixed paraffin embedded (FFPE) slides is mandatory. If archival tissue block is exhausted or not available, then a tissue biopsy FFPE sample is required unless a biopsy is not medically feasible. Only tissue from a surgical resection or a core needle, punch, or excisional/incisional biopsy sample collection will be accepted. Fine needle aspiration (FNA) samples are not acceptable.
- •7. Has measurable disease per RECIST 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as =10 mm with computer tomography (CT) or magnetic resonance imaging (MRI) scan. An enlarged lymph node must be =15 mm in short axis to be a measurable lesion.
- •8. Able to be safely administered and absorb study therapy
- •9. Has ECOG performance status 0 or 1.
- •10. Has a life expectancy of =3 months.
- •11. Has adequate organ function (screening assessment must be obtained within 14 days of first dose of study treatment):
- •11.1. Absolute neutrophil count =1500/mm3 without the use of hematopoietic growth factors
- •11.2. Platelet count =100,000/mm3 (must be at least 2 weeks post-platelet transfusion and not receiving platelet-stimulating agents)
- •11.3. Hemoglobin =9.0 g/dL (must be at least 2 weeks post-red blood cell transfusion)
- •11.4. Total and direct bilirubin =1.5 x the upper limit of normal (ULN). For participants with documented Gilbert’s disease, total bilirubin =3.0 mg/dL is allowed
- •11.5. Aspartate transferase (AST) and alanine transferase (ALT) =3 x ULN in the absence of documented liver metastases; =5 x ULN in the presence of liver metastases.
- •11.6. Serum albumin =3.0 g/dL.
- •11.7. Creatinine clearance =45 mL/min by Cockcroft-Gault equation (see Appendix 1, Section 14.1).
- •11.8. Prothrombin time/International Nor
排除标准
- •The presence of any of the following would exclude a participant from being eligible for the study:
- •1. Has received previous treatment with a PKC inhibitor (including prior treatment with IDE196) or an inhibitor directly targeting MET, or an inhibitor directly targeting GNAQ/11.
- •2. Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type.
- •3. Has AEs from prior anti-cancer therapy that have not resolved to Grade =1 except for alopecia or anemia.
- •3.1. Any ongoing diarrhea requires discussion with the Sponsor Medical Monitor
- •3.2. Endocrinopathies resulting from previous immunotherapy are considered part of medical history and not an AE.
- •3.3. Stable Grade 2 neuropathy is allowed
- •4. Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require doses of corticosteroids within the prior 3 weeks to study Day 1. Participants with brain metastases are eligible if lesions have been treated with localized therapy and there is no evidence of progression for at least 4 weeks by MRI prior to the first dose of study drug.
- •5. Known acquired immunodeficiency syndrome (AIDS)-related illness.
- •NOTE: human immunodeficiency virus (HIV) seropositive participants who are healthy and low risk for AIDS related outcomes could be considered eligible. Eligibility criteria for HIV positive participants should be evaluated and discussed with Sponsor Medical Monitor and will be based on current and past cluster of differentiation 4 (CD4) and T cell counts, history (if any) of AIDS defining conditions (eg, opportunistic infections), and status of HIV treatment. Also, the potential for drug-drug interactions should be taken into consideration.
- •6. Active adrenal insufficiency (eg, not stable on replacement therapy), active colitis, or active inflammatory bowel disease.
- •7. History of interstitial lung disease, active pneumonitis, or history of pneumonitis from prior therapies requiring corticosteroid treatment. However, history of grade 1 only pneumonitis OR prior radiation pneumonitis can be discussed with the Medical Monitor for consideration of inclusion.
- •8. History of syncope (except due to an acute medical condition [eg, hemorrhage] that is not likely to reoccur and with permission of the Sponsor Medical Monitor) within 6 months of the first dose of study treatment. Any history of potential syncope should be clarified and verified if possible. All participants with prior history of syncope should be discussed with the Sponsor Medical Monitor.
- •9. Active infection requiring systemic antibiotic therapy. Participants requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug
- •10. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the participant has a history of HBV or HCV infection. NOTE: participants with suspected hepatitis or human immunodeficiency virus (HIV) should be discussed with the Sponsor Medical Monitor.
- •11. Major surgery within 2 weeks of the first dose of study drug (mini
研究者
相似试验
进行中（未招募）
1 期
IDE196 (DAROVASERTIB) IN COMBINATION WITH CRIZOTINIB VERSUS INVESTIGATOR’S CHOICE OF TREATMENT AS FIRST-LINE THERAPY IN HLA-A2 NEGATIVE METASTATIC UVEAL MELANOMACTIS2023-506686-66-00Ideaya Biosciences Inc.251
进行中（未招募）
1 期
IDE196 (Darovasertib) in Combination with Crizotinib as First-line Therapy in Metastatic Uveal MelanomaHLA-A2 negative metastatic uveal melanomaMedDRA version: 21.1Level: PTClassification code: 10081431Term: Uveal melanoma Class: 100000004864CTIS2023-506686-66-01Ideaya Biosciences Inc.380
进行中（未招募）
2 期
(Treatments to shrink tumors before surgery, radiation or other forms of nondrug therapy) to use the investigational drug (Darovasertib) in patients with a type of cancer in the middle of the eye wall.arge, localized uveal melanomas in patientsEye DiseasesISRCTN12292888BC Late Stage (UK)82
招募中
1 期
(Treatments to shrink tumors before surgery, radiation or other forms of nondrug therapy) to use the investigational drug (Darovasertib) in patients with a type of cancer in the middle of the eye wall.veal MelanomaMedDRA version: 21.1Level: PTClassification code: 10081431Term: Uveal melanoma Class: 100000004864CTIS2023-506683-14-00Ideaya Biosciences Inc.82
进行中（未招募）
不适用
DOCETAXEL COMBINED WITH PULSATILE ERLOTINIB (TARCEVA) IN PATIENTS WITH METASTATIC NON SMALL CELL LUNG CANCER (NSCLC) - DOPERLOMetastatic (stage IV) non-small cell lung cancer (NSCLC) who have not previously been treated with anticancer drugsEUCTR2007-001555-19-GRHellenic Cooperative Oncology Group