A Phase III Randomized Placebo-Controlled Study of Pembrolizumab (MK-3475 NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA Stage IVB or Recurrent Endometrial Cancer

Brief description of study

The purpose of the study is to determine if we can lower the chance of your endometrial cancer growing or spreading by adding a new immunotherapy drug to the usual combination of chemotherapy drugs. We are doing this study because we want to find out if this approach is better or worse than the usual approach for your endometrial cancer. The usual approach for patients who are not in a study is treatment with surgery, radiation, or drugs including: carboplatin, paclitaxel, gemcitabine, pegylated liposomal doxorubicin, and topotecan (all U.S. Food and Drug Administration [FDA] approved agents). We want to see how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back (recurrent). In this study, the combination of pembrolizumab, paclitaxel and carboplatin are investigational, which means that the combination has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test these agents in the current trial.

Clinical Study Identifier: s21-00149
ClinicalTrials.gov Identifier: NCT03914612

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