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Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After First-Line Treatment in Advanced Triple Negative Breast Cancer (KEYLYNK-009)

Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After First-Line Treatment in Advanced Triple Negative Breast Cancer (KEYLYNK-009)

Clinicaltrials.gov identifier:
NCT04191135

Treatment:
Breast

Study Contact Information:

For additional information, please contact:

Toll Free Number: 1-888-577-8839 or email: Trialsites@merck.com


Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After First-Line Treatment in Advanced Triple Negative Breast Cancer (KEYLYNK-009)

About the Study

This study will look at how people with advanced triple-negative breast cancer (TNBC) respond to different combinations of drugs. The study will look at two different treatment periods:

  • Initial period: during this initial study period, participants will receive a combination of chemotherapy and immunotherapy drugs. Participants with stable cancer or an improvement will be able to continue to the next part of the study.
  • Followup period: Continuing participants will be assigned to one of two groups. One group will receive the same drug combination during the followup period. The second group will instead immunotherapy plus a type of targeted therapy known as a PARP inhibitor during the follow-up period.  

Type of Study

This will be an open-label, randomized study. For the initial period, all participants will receive the same drug combination. For the follow up period, participants will be assigned to one of two study groups by chance. Participants and their doctors will know which group they have been assigned to and which drugs they are receiving. 

What the Study Entails

During the initial period, all participants will receive the same treatment:

  • Chemotherapy (carboplatin with gemcitabine) intravenously (IV) on Days 1 and 8 of each 21-day cycle
  • Immunotherapy (pembrolizumab) IV on Day 1 of each 21-day cycle during the induction period for 4-6 cycles

During the follow-up period, participants will be randomly assigned to one of two groups:

  • Participants assigned to Group 1 will continue to receive:
    • Chemotherapy (carboplatin with gemcitabine) IV on Days 1 and 8 of each 21-day cycle
    • Immunotherapy (pembrolizumab) IV on Day 1 of each 21-day cycle
  • Participants assigned to Group 2 will receive:
    • Immunotherapy (pembrolizumab) IV on Day 1 of each 21-day cycle
    • PARP Inhibitor (olaparib) orally twice daily

Treatment in the study will continue as long as participants are tolerating treatment and their cancer remains stable or improves. 

Study participants will be followed for 72 months.

Study Sites

State City Facility Contact
California San Francisco UCSF Helen Diller Family Comprehensive Cancer Center 415-353-7288
Florida Miami University of Miami Sylvester Cancer Center 305-270-3435
Georgia Augusta Georgia Cancer Center at Augusta University  706-721-4430
Illinois Chicago University of Chicago 773-702-2065
Massachusetts Boston Massachusetts General Hospital 617-724-4800
Michigan Detroit Henry Ford Health System 313-916-9826
Minnesota Minneapolis Virginia Piper Cancer Institute 612-863-1093
New Jersey Middletown Memorial Sloan Kettering Cancer Center - Monmouth 646-888-5434
Montvale Memorial Sloan Kettering Cancer Center - Bergen 646-888-5434
New York Commack Memorial Sloan-Kettering Cancer Center at Commack 646-888-5434
New York Memorial Sloan-Kettering Cancer Center 646-888-5434
Oklahoma Oklahoma City Mercy Clinic Oncology and Hematology 405-752-3402
Texas Fort Worth The Center For Cancer And Blood Disorders 817-759-7013
New Braunfels Texas Oncology-New Braunfels 210-595-5300 
San Antonio Texas Oncology-San Antonio Northeast 210-595-5300
San Antonio Texas Oncology-San Antonio Medical Center 210-595-5300
San Antonio Texas Oncology - San Antonio Stone Oak 210-595-5300
The Woodlands Renovatio Clinical 713-703-2398
Virginia Newport News Virginia Oncology Associates 757-368-5033 
Norfolk Virginia Oncology Associates 757-368-5033 
Virginia Beach Virginia Oncology Associates 757-368-5033 
Washington Yakima Virginia Mason Memorial/North Star Lodge Cancer Center 509-574-3494
This Study is Open To:

Men and women age 18 years and older can be considered for enrollment in this study if they:

Initial Period:

  • Have inoperable Triple negative breast Cancer (TNBC) return in the same place as the original tumor and has not previously been treated with chemotherapy OR has metastatic TNBC that has not been previously treated with chemotherapy
  • Can provide a biopsy of a tumor that is no more than 3 years old and has not previously been exposed to radiation
  • Have a life expectancy > 27 weeks

Followup Period:

  • Have completed the necessary 4-6 cycles of the induction therapy, with no more than mild adverse effects
  • Have achieved complete response (CR), partial response (PR), or stable disease (SD at the Week 18 evaluation
  • Can complete (during post-induction) at least the Cycle 1, Day 1 doses of olaparib and pembrolizumab or the Cycle 1, Day 1 doses of at least one of the chemotherapy agents (carboplatin and/or gemcitabine) in addition to pembrolizumab
This Study is Not Open To:

Initial Period:

  • A known additional malignancy that is progressing or has required active treatment within the past 5 years (contact the study team for exceptions)
  • Had previous therapy with immunotherapy drugs such as pembrolizumab
  • Received prior therapy with either olaparib or any other PARP inhibitor
  • Severe lung disease
  • Active tuberculosis (TB)
  • Human immunodeficiency virus (HIV)
  • Hepatitis B or Hepatitis C
  • Limitations in heart function

Followup Period:

  • Severe and undesirable hypersensitivity to the study treatments
  • Received less than 4 cycles of chemotherapy plus pembrolizumab during the induction phase