A Phase II/III Study of Olaparib Plus Pembrolizumab Compared with Chemotherapy Plus Pembrolizumab after Initial Treatment with Chemotherapy Plus Pembrolizumab in Triple-Negative Breast Cancer

Share
Print

Full Title

An Open-label, Randomized, Phase 2/3 Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC) (KEYLYNK-009)

Purpose

This study is evaluating different treatments for triple-negative breast cancer (TNBC) that, after treatment, either came back in the same place as the original tumor (locally recurrent cancer) and cannot be removed surgically, or has spread to other parts of the body (metastatic cancer). Researchers want to learn if combining the drugs pembrolizumab and olaparib is a safe treatment for people with TNBC whose disease has responded to chemotherapy and pembrolizumab, and whether this combination treatment is as good as continuing pembrolizumab plus chemotherapy to extend the time before the cancer gets worse.

All study participants will first receive pembrolizumab plus chemotherapy with carboplatin and gemcitabine. Patients whose cancers do not worsen during this treatment will then be randomly assigned to receive pembrolizumab plus olaparib, or continue receiving pembrolizumab, carboplatin, and gemcitabine.

Pembrolizumab is a form of immunotherapy; its use for breast cancer is investigational. Olaparib is used to treat TNBC; its use with pembrolizumab is investigational. Olaparib is taken orally (by mouth) and the other medications are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have locally recurrent inoperable or metastatic TNBC.
  • Patients may not have previously received chemotherapy for advanced disease, nor olaparib or immunotherapy drugs such as pembrolizumab.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Mark Robson at 646-888-5486.

Protocol

20-092

Phase

II/III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators