A Phase II Study of Different Therapies in Women with Rare Ovarian Cancers with Genetic Changes

Share
Print

Full Title

A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients with Persistent or Recurrent Rare Epithelial Ovarian Tumors

Purpose

Researchers are doing this study to learn if various targeted therapies and immunotherapies are effective and safe in people with rare epithelial ovarian, fallopian tube, or peritoneal cancers which contain certain genetic mutations and which have come back or continued to grow despite prior treatment. A targeted therapy targets the genes or proteins that tell cancer cells to grow and survive. An immunotherapy helps the body’s immune cells to detect and destroy cancer cells.

Participants will be assigned to one of these treatment groups based on the specific genetic changes in their tumors:

  • Ipatasertib plus paclitaxel
  • Cobimetinib
  • Trastuzumab emtansine
  • Atezolizumab plus bevacizumab

Ipatasertinib and cobimetinib are taken orally (by mouth) and the other medications are given intravenously (by vein).

Eligibility

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

  • Participants must have non-high-grade serous, non-high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer that came back or continued to grow despite one to four prior regimens of treatment.
  • Patients must be able to wait at least 6-8 weeks before starting the study therapy and should ideally screen for this study while they are receiving active treatment.
  • The serious side effects of previous therapies should go away before the study treatment 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 women age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr. Rachel Grisham at 646-888-4653.

Protocol

21-297

Phase

II

Investigator

Co-Investigators