A Phase 2 Study of Nivolumab in Combination with Either Rucaparib, Docetaxel, or Enzalutamide in Men with Castration-resistant Metastatic Prostate Cancer (CheckMate-9KD)

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. 

NOTE: This study is no longer enrolling. 

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