Last updated on September 2018

Biomarker-Driven Therapy With Nivolumab and Ipilimumab in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Expressing AR-V7

Brief description of study

This phase II trial studies how well nivolumab and ipilimumab work in treating patients with hormone-resistant prostate cancer that has spread to other places in the body and express androgen receptor-variant-7 (AR-V7). Tumor cells expressing AR-V7 has been shown to be resistant to hormone therapy and some chemotherapy in patients with prostate cancer. Biomarker-driven therapy, such as nivolumab and ipilimumab, may work by blocking key biomarkers or proteins that help tumor cells to escape the immune system surveillance and this may help the immune system to kill tumor cells that express AR-V7.

Detailed Study Description


  1. To evaluate the effect of administration of nivolumab and ipilimumab on the proportion of prostate-specific antigen (PSA) responses (> 50% PSA decline) in metastatic castration-resistant prostate cancer (mCRPC) patients with detectable ARV7 transcript in circulating tumor cells (CTCs).


  1. To evaluate the safety and tolerability of ipilimumab + nivolumab in ARV7-positive patients.
  2. To determine the progression free survival (PFS).
  3. To determine the PSAPFS.
  4. To determine the proportion of "durable" responses.
  5. To determine the overall response rate (ORR).
  6. To determine the overall survival (OS).
  7. To evaluate changes in ARV7 detection (or expression levels) before and after treatment with ipilimumab + nivolumab and correlate with PSA responses.
  8. To explore potential biomarkers associated with clinical efficacy (ORR, PFS, and OS) of nivolumab and ipilimumab by analyzing absolute lymphocyte count in peripheral blood as well as programmed cell death 1 ligand 1 (PDL1) expression in CTCs and/or in tumor biopsies, and immune profiling of sera and tumor tissue.

Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90 minutes every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 60 minutes every 2 weeks for 36 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 100 days and then every 3 months.

Clinical Study Identifier: NCT02601014

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