Phase
Condition
Endometrial Cancer
Carcinoma
Treatment
Carboplatin
Paclitaxel
Dostarlimab
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant has histologically or cytologically proven endometrial cancer withrecurrent or advanced disease.
Participant has molecular subtype of defective mismatch repair/microsatelliteinstability high (dMMR/MSI-H) or mismatch repair proficient/microsatellite stable (MMRp/MSS) determined.
Participant must have primary Stage III or Stage IV disease or first recurrentendometrial cancer with a low potential for cure by radiation therapy or surgeryalone or in combination, and presence of at least one measurable lesion per RECIST 1.1 based on Investigator's assessment.
Participant is not pregnant or breastfeeding and agrees to use a highly effectivecontraceptive method during the study period if a woman of childbearing potential (WOCBP).
Participant has an Eastern Cooperative Oncology Group Performance status (ECOG PS)of 0 or 1.
Participant has adequate organ function, as assessed by hematologic, renal, hepaticand coagulation parameters.
Exclusion
Exclusion Criteria:
Participant has a concomitant malignancy, or participant has a prior non-endometrialinvasive malignancy who has been disease-free for <3 years or who received anyactive treatment in the last 3 years for that malignancy. Non-melanoma skin canceris allowed.
Participant has any medical history of interstitial lung disease or pneumonitis.
Participant has cirrhosis or current unstable liver or biliary disease.
Participant has known uncontrolled central nervous system metastases, carcinomatosismeningitis, or both.
Participant has a diagnosis of immunodeficiency.
Participant has received prior therapy with an anti- Programmed death protein 1 (PD-1), anti- Programmed death ligand 1 (PD-L1), anti- Programmed death ligand 2 (PD-L2), or anti- Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) agent.
Participant has not recovered adequately from AEs.
Participant has received prior anticancer therapy (chemotherapy, targeted therapies,hormonal therapy, radiotherapy, or immunotherapy) within 21 days or <5 times thehalf-life of the most recent therapy prior to the first dose of study intervention,whichever is shorter.
Participant has received any live vaccine within 30 days of the first dose of studyintervention. Vaccination against coronavirus disease 2019 (COVID-19) using vaccinesthat are authorized via the appropriate regulatory mechanisms are not exclusionary.
Participant has HBsAg positive, or HCV RNA positive.
Participant is known HIV infection.
Participant is currently participating and receiving study intervention or hasparticipated in a study of an investigational agent and received study interventionor used an investigational device within 4 weeks of the first dose of treatment.
Participant with contraindication to carboplatin and paclitaxel.
Study Design
Connect with a study center
GSK Investigational Site
Aichi, 464-8681
JapanActive - Recruiting
GSK Investigational Site
Chiba, 260-8717
JapanActive - Recruiting
GSK Investigational Site
Ehime, 791-0280
JapanActive - Recruiting
GSK Investigational Site
Fukuoka, 830-0011
JapanActive - Recruiting
GSK Investigational Site
Gunma, 373-8550
JapanActive - Recruiting
GSK Investigational Site
Hokkaido, 060-8648
JapanActive - Recruiting
GSK Investigational Site
Hyogo, 673-8558
JapanActive - Recruiting
GSK Investigational Site
Ibaraki, 305-8576
JapanActive - Recruiting
GSK Investigational Site
Iwate, 028-3695
JapanActive - Recruiting
GSK Investigational Site
Kanagawa, 259-1193
JapanActive - Recruiting
GSK Investigational Site
Okayama, 700-8558
JapanActive - Recruiting
GSK Investigational Site
Osaka, 569-8686
JapanActive - Recruiting
GSK Investigational Site
Saitama, 350-1298
JapanActive - Recruiting
GSK Investigational Site
Shizuoka, 411-8777
JapanActive - Recruiting
GSK Investigational Site
Tochigi, 329-0498
JapanActive - Recruiting
GSK Investigational Site
Tokyo, 160-8582
JapanActive - Recruiting
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