MK-2870 in Post Platinum and Post Immunotherapy Endometrial Cancer

JRCT ID: jRCT2031240041

Registered date:21/04/2024

Basic Information

• Recruitment status: Recruiting
• 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

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 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: Koh Yasuhiro