2023-504816-14-00招募中3 期
A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician’s Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (MK-2870-005/ENGOT-en23/GOG-3095)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 267
- 试验地点
- 81
- 主要终点
- Progression free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
研究概览
简要总结
- To compare MK-2870 to Treatment of Physician’s Choice (TPC) with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR)
- To compare MK-2870 to TPC with respect to overall survival (OS)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
- •Has radiographically evaluable disease, either measurable or nonmeasurable per RECIST 1.1, as assessed by BICR.
- •Has received prior platinum-based chemotherapy and anti- programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.
排除标准
- •Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas.
- •Has received prior treatment with a topoisomerase I inhibitor-containing ADC (eg, sacituzumab govitecan or fam-trastuzumab deruxtecan-nxki)
- •Requires recurrent drainage of effusions (e.g., pleural, ascitic, etc.) within 6 weeks before randomization
- •Has previously received both single-agent paclitaxel and single-agent doxorubicin in any setting for prior treatment of endometrial cancer
- •Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- •Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
- •Has had a recurrence of endometrial carcinoma or carcinosarcoma more than >12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting. This includes:1) If Immunotherapy-based treatment is administered in the recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from time of adjuvant therapy 2) For Stage IVb disease, treatment that includes gynecological surgery followed by a platinum-based regimen is NOT considered curative-intent per protocol and does not require platinum rechallenge in the recurrent setting, regardless of the duration of the platinum-free interval
- •Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma.
- •Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •Has received prior treatment with single-agent nonplatinum based chemotherapy in the third-line setting
- •Has received prior treatment with a trophoblast cell surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC) (eg, sacituzumab govitecan)
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Progression free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
Progression free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
Overall Survival (OS)
Overall Survival (OS)
次要结局
- Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR
- Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
- Number of Participants Who Experience One or More Adverse Events (AEs)
- Number of Participants Who Discontinue Study Intervention Due to an AE
- Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30]
研究者
Kristina Woodhouse
Scientific
Merck Sharp & Dohme LLC
研究点 (81)
Loading locations...
相似试验
招募中
3 期
A clinical study of MK-1084 and other treatments for lung cancer (MK-1084-007)2024-514500-14-00Merck Sharp & Dohme LLC206
招募中
3 期
A clinical study of opevesostat and standard hormone therapy in people with prostate cancer (MK-5684-004)2023-504957-11-00Merck Sharp & Dohme LLC401
已完成
1 期
Phase 1b study to evaluate MK 0482 for Relapsed/Refractory AML/CMML2023-503580-42-00Merck Sharp & Dohme LLC15
招募中
3 期
A study to learn more about how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced non-small cell lung cancer (NSCLC) with mutations of the human epidermal growth factor receptor 2 (HER2)2024-511319-91-00Bayer AG145
招募中
2 期
Prospective study in patients with colon or rectum cancer with liver metastasis of the efficacy and toxicity of standard therapy (chemotherapy + targeted therapy) combined with immunotherapy and internal radiotherapy targeting the liver2024-517204-11-00Fondation Franc.Cancerologie Digestive52