NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031240041

Registered date:21/04/2024

MK-2870 in Post Platinum and Post Immunotherapy Endometrial Cancer

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedEndometrial cancer
Date of first enrollment30/05/2024
Target sample size70
Countries of recruitmentUnited 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 typeInterventional
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
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
Age maximumNot applicable
GenderFemale
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

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
E-mail 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
E-mail msdjrct@merck.com
Affiliation MSD K.K.