A Phase 2 Study of Darolutamide in Combination with Leuprolide Acetate in Hormone-Therapy Na ve Recurrent and/or Metastatic Androgen Receptor (AR) Positive Salivary Gland Cancer

Brief description of study

We want to study if combining two drugs, ADT and darolutamide, can help patients with a type of cancer called salivary gland carcinoma. We will focus on patients whose cancer has a specific marker called the AR+ (androgen receptor positive) subtype. Other studies have shown mixed results with this type of treatment in patients with AR+ subtype, so we need more information to know if it works well. In the United States, there has only been one study with a similar drug called enzalutamide, and it had a low success rate of 4%.

In Japan, two studies showed better results with ADT (one of the main drugs being used in our study) and antiandrogen. One study had a response rate of 42%, and the other had a rate of 25%. We believe that using a more powerful drug called darolutamide (the other drug in our study) in replace of antiandrogen will work better and increase the response rate in American patients with this rare cancer.

To test this, we will enroll patients in our study and if 33% show a good response to the treatment, we will continue with more patients. However, if less than 33% of the patients respond well in the first group, we will stop the study. We will consider the study successful if most of the patients respond well in both groups together. We have designed the study this way to make sure we don't miss any potential benefits of the treatment.

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