KCT0007575招募中未知
Phase II trial of Lenvatinib plus PembrolizumAb in Recurrent gynecological clear cell Adenocarcinomas (LARA)
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- Female
入选标准
- •1. Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of recurrent CCGC (ovarian and endometrial primary), as evidenced by WT-1 negativity, will be enrolled in this study. For tumors with a mixed histology, at least 70% of the tumor must consist of clear cell carcinoma.
- •2. Patients must have had at least one prior line of platinum-based chemotherapy in the course of their treatment paradigm. A maximum of 4 prior lines of systemic treatment regimens will be allowed and may include chemotherapy and biologics (prior immune checkpoint inhibitor treatment will not be permitted).
- •3. Participants must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment.
- •4. A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
- •a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
- •b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 120 days after the last dose of study treatment.
- •5. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- •6. Have at least 1 measurable lesion based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •7. Provision of an archived tumor tissue block (or at least 10 newly cut unstained slides) where such samples exist in a quantity sufficient to allow for analysis.
- •8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation/randomization.
- •9. Life expectancy exceeding 12 weeks.
- •10. Have adequate organ function as defined in the following table (Table 1). Specimens must be collected within 10 days prior to the start of study treatment.
- •Absolute neutrophil count (ANC) =1500/µL
- •Platelets =100 000/µL
- •Hemoglobin =9.0 g/dL or =5.6 mmol/La
- •Creatinine ORMeasured or calculatedb creatinine clearance(GFR can also be used in place of creatinine or CrCl) =1.5 × ULN OR=30 mL/min for participant with creatinine levels >1.5 × institutional ULN
- •Total bilirubin =1.5 ×ULN OR direct bilirubin =ULN for participants with total bilirubin levels >1.5 × ULN
- •AST (SGOT) and ALT (SGPT) =2.5 × ULN (=5 × ULN for participants with liver metastases)
- •International normalized ratio (INR) OR prothrombin time (PT) =1.5 × ULN unless participant is receiving
- •Activated partial thromboplastin time (aPTT) anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
排除标准
- •1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.
- •2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
- •3. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation. Participants must have recovered from all AEs due to previous therapies to =Grade 1 or baseline. Participants with =Grade 2 neuropathy may be eligible. If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment. Withhold lenvatinib for at least 1 week prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of lenvatinib after resolution of wound healing has not been established”.
- •4. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.
- •5. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
- •6. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- •7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- •8. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in-situ cancers.
- •9. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note
研究者
相似试验
招募中
不适用
Phase II trial of pembrolizumab in combination with paclitaxel in the hormone receptor-positive metastatic breast cancer with high tumor mutational burden selected by whole exome sequencing: Korean Cancer Study Group trialKCT0007042Yonsei University Health System, Severance Hospital52
进行中（未招募）
1 期
Phase II trial of Pembrolizumab in combination with Doxorubicin in Advanced, Recurrent or Metastatic Endometrial Cancer (TOPIC)Advanced, Recurrent or Metastatic Endometrial CancerMedDRA version: 12.0 Level: HLGT Classification code 10007129 Term: Cancer-related morbidities System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-002824-26-ESVall d' Hebron Institute of Oncology (VHIO)51
招募中
1 期
A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast CancerMetastatic Breast CancerNCT06110793Memorial Sloan Kettering Cancer Center56
进行中（未招募）
2 期
A Study of Pembrolizumab With Lenvatinib in Women With Advanced Uterine CarcinosarcomaUterine CarcinosarcomaAdvanced Uterine CarcinosarcomaNCT05147558Memorial Sloan Kettering Cancer Center40
进行中（未招募）
2 期
Study of Pembrolizumab, Lenvatinib and Chemotherapy Combination in First Line Extensive-stage Small Cell Lung CancerSmall Cell Lung Cancer Extensive StageNCT05384015Fundación GECP46