JRCT ID: jRCT2031240041
Registered date:21/04/2024
MK-2870 in Post Platinum and Post Immunotherapy Endometrial Cancer
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Endometrial cancer |
Date of first enrollment | 30/05/2024 |
Target sample size | 70 |
Countries of recruitment | United States of America,Japan,Canada,Japan,Argentina,Japan,Brazil,Japan,Chile,Japan,Mexico,Japan,Puerto Rico,Japan,Austria,Japan,Belgium,Japan,Czech Republic,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan,United Kingdom,Japan,Australia,Japan,Malaysia,Japan,Singapore,Japan,South Korea,Japan,China,Japan |
Study type | Interventional |
Intervention(s) | -Arm 1:MK-2870 4 mg/kg administered q2w -Arm 2:TPC consisting of either doxorubicin 60 mg/m2 administered q3w or paclitaxel 80 mg/m2, administered on Days 1, 8, and 15 of each 28-day cycle |
Outcome(s)
Primary Outcome | -Overall Survival (OS) -Progression-Free Survival (PFS) per RECIST 1.1 by BICR |
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Secondary Outcome | -Objective response rate (ORR) per RECIST 1.1 by BICR -Duration of response (DOR) per RECIST 1.1 by BICR -Adverse events (AEs) -Study intervention discontinuation due to AEs -Change from baseline in EORTC QLQ-C30 Global Health Status/QoL |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Female |
Include criteria | -Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma. -Has radiographically evaluable disease, either measurable or nonmeasurable per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (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. |
Exclude criteria | -Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas. -Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or 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 180 days after completing platinum-based therapy administered in the curative-intent or adjuvant setting without any additional platinum-based therapy received in the metastatic or recurrent setting. -Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma. |
Related Information
Primary Sponsor | Tanaka Yoshiyuki |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | MSDJRCT inquiry mailbox |
Address | KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667 |
Telephone | +81-3-6272-1957 |
msdjrct@merck.com | |
Affiliation | MSD K.K. |
Scientific contact | |
Name | Yoshiyuki Tanaka |
Address | KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667 |
Telephone | +81-3-6272-1957 |
msdjrct@merck.com | |
Affiliation | MSD K.K. |