Chemotherapy, Immunotherapy and PARP Inhibitor for the Treatment of Metastatic Aggressive Variant Prostate Cancer

About the Study

NOTE: This study is no longer recruiting patients. 

This study will look at how well the combination of chemotherapy drugs (such as cabazitaxel and carboplatin), a PARP inhibitors (niraparib), and an immunotherapy agents (cetrelimab) works for treating people with a rare type of prostate cancer known as aggressive variant prostate cancer (AVPC). The research will compare the benefits of giving niraparib with or without cetrelimab, after treatment with chemotherapy.

Type of Study

This is a two-arm, randomized, open-label study.

• Participants will be placed into one of two study groups by chance, neither the participants nor the researchers choose the group into which the participants are placed. Participants will be told which group they have been assigned to. 
• Participants will have treatment in two phases during this study. During Phase 1, the induction phase, participants will all receive the same treatment with chemotherapy and immunotherapy. Phase 2, the maintenance phase will begin after participants have completed chemotherapy and immunotherapy. During Phase 2, participants in each group will receive different treatment. 
  • Group 1 will receive treatment with a PARP inhibitor.  
  • Group 2 will receive treatment with a PARP inhibitor combined with an immunotherapy.

What the Study Involves

Induction phase

• Patients in both groups will receive the chemotherapy agents cabazitaxel intravenously (IV) and carboplatin IV on day 1.
• Beginning in cycle 2, all patients will also receive the immunotherapy cetrelimab IV on day 1.
• Treatment repeats for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Maintenance phase

• Group 1
  • Participants will take niraparib orally each day on days 1-28.
  • Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Group 2
  • Participants will receive cetrelimab IV on day 1.
  • Participants will take niraparib orally each day on days 1-28.
  • Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Study participants will be followed up to 5 years.