CTIS2023-506686-66-01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 Melanoma - IDE196-002
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Must be at least 18 years of age., 10. Has a life expectancy of =3 months., 11. Has adequate organ function (screening assessment must be obtained within 14 days of the first dose of study treatment): • Absolute neutrophil count =1500/mm3 without the use of hematopoietic growth factors • Platelet count =100,000/mm3 (must be at least 2 weeks post-platelet transfusion and not receiving platelet-stimulating agents) • Hemoglobin =9.0 g/dL (must be at least 2 weeks post-red blood cell transfusion) • 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 • 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 • Serum albumin =3.0 g/dL • Creatinine clearance =45 mL/min by Cockcroft-Gault equation (see Appendix 1, Section 14.1) • Prothrombin time/International Normalized Ratio (INR) or partial thromboplastin time test results at screening =1.5 x ULN (this applies only to participants who do not receive therapeutic anticoagulation; participants receiving therapeutic anticoagulation should be on a stable dose for at least 2 weeks prior to the first dose of study drug), 12. Women of childbearing potential who are sexually active with a non-sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during study treatment (see Appendix 5, Section 14.5), and must agree to continue using such precautions for 6 months after the final dose of study treatment; cessation of birth control after this point should be discussed with a responsible physician. Highly effective methods of contraception are described in Appendix 5, Section 14.5., 13. Male participants must be surgically sterile or must agree to use double barrier contraception methods from enrollment through treatment and for 6 months following administration of the last dose of study treatment., 2. Written, informed consent has been obtained before initiation of any study related-procedures, and the participant 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: • No prior systemic therapy in the metastatic or advanced setting including chemotherapy, immunotherapy, or targeted therapy • No prior regional, liver-directed therapy including chemotherapy, radiotherapy, or embolization • Prior ablations or surgical resection of oligometastatic disease are allowed • 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 since the end of neoadjuvant/adjuvant treatment and the start of study treatment o 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 o Participants who have received an anti-PD(L)1 agent as prior neoadjuvant/adjuvant treatment should not receive pembrolizumab as investigator’s choice therapy o Participants who have received a dacarbazine-containing regimen as prior neoadjuvant/adjuvant treatment should not receive dacarbazine as in
排除标准
- •Has received previous treatment with a PKC inhibitor (including prior treatment with IDE196), an inhibitor directly targeting MET, or an inhibitor directly targeting GNAQ/11., 18. Has an allergy to mammalian meat products or gelatin., 19. Contraindication for treatment with investigator’s choice alternatives (dacarbazine, ipilimumab + nivolumab, and pembrolizumab) as per applicable labelling. Participants may have a contraindication to one or two of the choices if he/she is a candidate for dosing with at least one investigator’s choice and meets all other study eligibility criteria. Choice of dacarbazine should only be made in the setting where treatment with immunotherapy is deemed likely to result in irreversible serious (or life threatening) AEs (eg. severe active autoimmune disease requiring potent immunosuppression) and must be discussed with the Medical Monitor., 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., 20. History of stroke within the last 6 months of the first dose of study drug., 3. Has AEs from prior anti-cancer therapy that have not resolved to Grade =1 except for alopecia or anemia: • Any ongoing diarrhea requires discussion with the Sponsor Medical Monitor • Endocrinopathies resulting from previous immunotherapy are considered part of medical history and not an AE • 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 disc
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