About this trial
This study will evaluate the safety of dostarlimab in combination with carboplatin and paclitaxel followed by monotherapy when administered as a first-line treatment in advanced or recurrent endometrial cancer (EC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant with greater than or equals to (>=) 18 years of age, at the time of signing the informed consent.
Participant has histologically or cytologically proven EC with recurrent or advanced disease.
Participant must have primary Stage III or Stage IV disease or first recurrent EC with a low potential for cure by radiation therapy or surgery alone or in combination based on investigator's assessment.
Eligible for dostarlimab treatment according to the approved prescribing information and the investigator's clinical judgement.
Disqualifiers
Participant has had greater than (>) 1 recurrence of endometrial cancer.
Participant has a concomitant malignancy, or participant has a prior non endometrial invasive malignancy who has been disease-free for less than (<) 3 years or who received any active treatment in the last 3 years for that malignancy.
Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy.
Trial design
Single group
Treatments tested in this trial
Dostarlimab
DrugDostarlimab will be administered.
Carboplatin
DrugCarboplatin will be administered.
Paclitaxel
DrugPaclitaxel will be administered.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with Grade 3 or greater treatment-emergent adverse events (TEAEs) up to Week 49
Secondary outcomes
Number of participants with Grade 3 or greater TEAEs up to Week 170
Number of participants with TEAEs up to Week 49
Number of participants with TEAEs up to Week 170
Number of participants with Immune-related adverse events (irAEs) up to Week 49
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: