Treatment with Pembrolizumab/Placebo with Carboplatin and Paclitaxel for Advanced Stage or Recurrent Endometrial Cancer

Clinical Trial Title

NRG-GY018: A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475) in addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

National Clinical Trial Number:

NCT03914612

Contact Information

Lois Winkelman, RNMS

Clinical Trial Protocol Description:

A study of pembrolizumab or placebo IV given with standard chemotherapy: Carboplatin and paclitaxel given every 3 weeks for 6-8 cycles with maintenance pembrolizumab or placebo IV given every 6 weeks for up to 2 years for advanced stage endometrial cancer or recurrent endometrial cancer. The goal of the trial is to determine if adding the immunotherapy, pembrolizumab will increase disease free interval when given with standard of care chemo.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Are 18 years of age or older.
  • You must have an advanced stage of Endometrial cancer (Stage III or IV) with disease measurable on a CT scan.
  • You may have received prior chemo with Carboplatin/Paclitaxel, but it must be greater than 12 months since it has been completed.
  • You must have adequate organ and bone marrow function

You will be excluded from the study if any of the following criteria apply to you:

  • You have had any other chemotherapy treatment or have received any other immunotherapy agents.
  • You have an auto-immune disease or any illness that requires steroid therapy.
  • You have brain metastasis that has gotten worse.

This is a partial list of inclusion and exclusion criteria.

Study Details

Clinical Trial Investigator

Jean-Marie Stephan, MD

Contact Information

Lois Winkelman, RNMS

Clinical Trial Location

Rush University Cancer Center

Location

Rush University Cancer Center

1725 W Harrison St
Professional Building - Suite 1010
Chicago, IL 60612

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