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Active Not Recruiting
NCT06317311
A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer
Conditions: Carcinoma
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 41
Sponsor: GlaxoSmithKline
Location: GSK Investigational Site Aichi
Summary
The goal of this clinical trial is to understand the effectiveness of dostarlimab and carboplatin-paclitaxel followed by dostarlimab monotherapy in participants with endometrial cancer
Eligibility Criteria
Inclusion Criteria:
1. Participant has histologically or cytologically proven endometrial cancer with recurrent or advanced disease.
2. Participant has molecular subtype of defective mismatch repair/microsatellite instability high (dMMR/MSI-H) or mismatch repair proficient/microsatellite stable (MMRp/MSS) determined.
3. Participant must have primary Stage III or Stage IV disease or first recurrent endometrial cancer with a low potential for cure by radiation therapy or surgery alone or in combination, and presence of at least one measurable lesion per RECIST 1.1 based on Investigator's assessment.
4. Participant is not pregnant or breastfeeding and agrees to use a highly effective contraceptive method during the study period if a woman of childbearing potential (WOCBP).
5. Participant has an Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0 or 1.
6. Participant has adequate organ function, as assessed by hematologic, renal, hepatic and coagulation parameters.
Exclusion Criteria:
1. Participant has a concomitant malignancy, or participant has a prior non-endometrial invasive malignancy who has been disease-free for \
Source: ClinicalTrials.gov (NCT06317311). StuddyBuddy aggregates publicly available trial information.