A Phase 3 Study of Nemvaleukin plus Pembrolizumab Immunotherapy versus Standard Chemotherapy in Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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Full Title

A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator’s Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7) (WIRB)

Purpose

The purpose of this study is to compare the effectiveness of the immunotherapy drugs nemvaleukin and pembrolizumab individually and together versus standard chemotherapy in people with ovarian, fallopian tube, or primary peritoneal cancer that continues to grow despite platinum-containing chemotherapy. The medications used in this study are given intravenously (by vein).

Nemvaleukin binds to a protein known as the interleukin-2 receptor and may stimulate the immune system to destroy cancer cells. Pembrolizumab takes the brakes off the immune response and allows immune cells to find and kill cancer cells. In this study, participants will be randomly assigned to receive one of these treatments:

  • Nemvaleukin plus pembrolizumab
  • Nemvaleukin alone
  • Pembrolizumab alone
  • Standard chemotherapy, as chosen by the study doctor

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have ovarian, fallopian tube, or primary peritoneal cancer that continues to grow despite at least one but no more than five prior regimens of therapy that included platinum-containing chemotherapy and bevacizumab.
  • The serious side effects of previous treatments must go away before the study therapy is given.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Roisin O’Cearbhaill at 646-888-4227.

Protocol

22-294

Phase

Phase III (phase 3)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05092360