CheckMate-9KD for Men with Metastatic Prostate Cancer

Clinicaltrials.gov identifier:
NCT03338790

Treatment:
Prostate

About the Study

CheckMate-9KD is a clinical research study for men with metastatic prostate cancer (which means cancer that has spread) that no longer responds to treatments that lower testosterone. The purpose of this study is to compare three different combination therapies, each containing a drug called nivolumab and another anti-cancer drug. All three combination therapies are considered investigational, which means that they are not currently approved to treat men with metastatic prostate cancer.  The three drugs which will be studied in combination with Nivolumab are:

• Rucaparib (a therapy known as a PARP inhibitor)
• Docetaxel (a type of chemotherapy)
• Enzalutamide (a type of hormone therapy that targets androgen receptors)

The study doctors want to learn more about which combination therapy is most effective in treating metastatic prostate cancer.

Visit Bristol-Myers Squibb's Study Connect site or Clinicaltrials.gov for more information on the study. 

Type of Study

CheckMate-9KD is a three-arm, non-randomized, open-label study.

• This study has 3 arms, which means that each patient will be assigned into one of three different groups. Each group will receive different therapies in combination with Nivolumab.
• The study is non-randomized, meaning that each patient will know which group he is assigned to, based on the specifics of his cancer and prior treatment.
• The study is open-label. All participating patients will receive the study agent, Nivolumab plus another agent. Participants will know which group they have been assigned to.

What the Study Entails

Biopsy sample. All patients interested in enrolling must submit pre-treatment tumor tissue. Participants with tissue from a prior biopsy acquired within 5 years of enrollment will not require additional biopsy. Participants who do not have available tissue from a prior biopsy must undergo a biopsy in order to participate.

Treatment arms. All participants will be assigned to one of three treatment groups.

• Group A will receive Nivolumab intravenously (IV) every 4 weeks and the PARP inhibitor Rucaparib orally twice daily.
• Group B will receive Nivolumab IV every 3 weeks and the chemotherapy Docetaxel IV Every 3 weeks up to 10 cycles along with Prednisone orally twice daily.
• Group C will receive Nivolumab IV every 4 weeks along with the hormonal therapy Enzalutamide 160 mg/day orally once daily.

Treatment arm assignment. Treatment arm assignment will depend on the following variables:

• prior treatment history
• presence or absence of measurable disease on the baseline tumor assessment per investigator review; and
• presence or absence of a certain tumor trait known as homologous recombination deficiency (HRD). 

Monitoring and follow up visits.

• During the treatment phase, efficacy assessments will include CT, MRI and Bone scans every 8-9 weeks.
• Follow up visits including additional scans should occur 30 days and 100 days from last dose of study drug.
• Survival follow up every 3 month for safety

Study Sites - United States

• Alabama
  • Daphne, AL
    • Southern Cancer Center - Site #0036
    • Contact: Dr. Michael Meshad: 251-607-5036
• California
  • Rancho Mirage, CA
    • Desert Hematology Oncology Medical Group - Site #0010
    • Contact: Dr. David Young  760-568-3613 
• Connecticut
  • New Haven, CT
    • Yale University School of Medicine - Site #0049
    • Contact: Daniel Petrylak 203-785-6821 or by email
• Florida
  • Miami, FL
    • Baptist Health Medical Group Oncology - Site #0037
    • Contact: Dr. Antonio Muina 786-596-7706
• Georgia
  • Marietta, GA
    • Northwest Georgia Oncology Centers - Site #0009
    • Contact: Kristine Parker  770-333-2161
• Kentucky
  • Louisville, KY
    • Norton Cancer Institute - Site #0065
    • Contact: Arash Rezazadeh Kalebasty, Site 0065
• Maryland
  • Rockville, MD
    • Maryland Oncology Hematology - Site #0040
    • Contact: Manish Agrawal  410-964-2212 or by email 
• Mississippi
  • Jackson, MD
    • Jackson Oncology Associates - Site #0069
    • Contact: Dr. Justin Baker 601-355-2485
• Missouri
  • St. Louis, MO
    • Washington University School Of Medicine - Site #0011
    • Contact: Russell Pachynski 314-747-1343
• Nebraska
  • Omaha,NE
    • Nebraska Cancer Specialists - Site #0035
    • Contact: Ralph Hauke 402-691-6971
• New York
  • Amsterdam, NY
    • New York Oncology Hematology - Site #0038
    • Contact: David Shaffer 518-262-2767 
• North Carolina
  • Durham, NC
    • Duke University - Site #0041
    • Contact Julia Rasmussen 919-681-1030
• Oregon
  • Providence, OR
    • Providence Portland Medical Center - Site #0024
    • Contact: Scot Lary 503-215-2604
• Pennsylvania
  • Allentown, PA
    • Lehigh Valley Health Network - Site: #0053
    • Contact: Dr. Maged Khalil 610-402-7880
• Virginia
  • Fairfax, VA
    • Virginia Cancer Care Specialist - Site: #0039
    • Contact: Daniel Chong 540-662-1108 

Study Sites - International

This study is enrolling patients internationally, including in the following countries:

• Argentina
• Australia
• Brazil
• Canada
• Chile
• France
• Germany 
• Mexico
• Spain

Visit Bristol-Myers Squibb's Study Connect site or Clinicaltrials.gov for a more complete list of study sites.