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New treatment option for Neoplasms, Endometrial
Official title A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recurrent Endometrial Cancer (EC)
ClinicalTrials.gov ID: NCT07108270
What this study is testing
What is Dostarlimab?
Dostarlimab is an investigational medicine, being studied as a potential treatment for neoplasms, endometrial.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to see how well dostarlimab works when administered with the chemotherapy drugs carboplatin and paclitaxelin in treating EC in Chinese participants. The study aims to understand the treatments effectiveness, safety, how the drugs behave in the body, and whether it causes any immune reactions.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Participant has histologically or cytologically proven EC with recurrent or advanced disease.
- Participant has molecular subtype of defective mismatch repair (dMMR) or microsatellite instability high (MSI-H) determined by the central reference...
- 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...
- Has primary Stage III to IV disease and is naive to systemic anticancer therapy for EC;
- Has first recurrent disease and is naïve to systemic anticancer therapy for EC;
You likely can't join if
- Participant has a concomitant malignancy, or participant has a prior non-endometrial invasive malignancy who has been disease-free for \<3 years or...
- 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, carcinomatosis meningitis, 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...
See the full eligibility criteria
- Participant has histologically or cytologically proven EC with recurrent or advanced disease.
- Participant has molecular subtype of defective mismatch repair (dMMR) or microsatellite instability high (MSI-H) determined by the central reference laboratory before study intervention.
- 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, and presence of at least one target lesion per...
- Has primary Stage III to IV disease and is naive to systemic anticancer therapy for EC;
- Has first recurrent disease and is naïve to systemic anticancer therapy for EC;
- Had received prior neo-adjuvant/adjuvant anticancer therapy and had a recurrence or PD ≥6 months after completing treatment (first recurrence only).
- Participant has adequate archive tumor tissue sample for MMR/MSI status testing. If no archival tissue is available, tissue sample must be obtained before study intervention.
- 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).
- 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, hepatic and coagulation parameters.
- Participant has a concomitant malignancy, or participant has a prior non-endometrial invasive malignancy who has been disease-free for \<3 years or who received any active treatment in the last 3 years for that...
- 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, carcinomatosis meningitis, 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...
- Participant has not recovered adequately from AEs.
- Participant has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy, or immunotherapy) within 21 days prior to the first dose of study intervention.
- Participant has received any live vaccine within 30 days of the first dose of study intervention. Vaccination against coronavirus disease 2019 (COVID-19) using vaccines that are authorized via the appropriate regulatory...
- Participant has Hepatitis B surface antigen (HBsAg) positive, or Hepatitis C virus (HCV) Ribonucleic acid (RNA) positive at screening or within 3 months prior to the first dose of study intervention.
- Participant is known human immunodeficiency virus (HIV) infection.
- Participant is currently participating and receiving study intervention or has participated in a study of an investigational agent and received study intervention or used an investigational device within 4 weeks of the...
- Participant with contraindication to carboplatin and paclitaxel.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.