A Phase 2 Study of Darolutamide in People With Testosterone-Driven Salivary Gland Cancer


Full Title

A Phase 2 Study of Darolutamide in Combination with Leuprolide Acetate in Hormone-Therapy Naïve Recurrent and/or Metastatic Androgen Receptor (AR) Positive Salivary Gland Cancer (NCI 10553) (CIRB)


Researchers want to learn how well darolutamide and leuprolide acetate work for people with salivary gland cancers. The people in this study have salivary cancer that has spread, cannot be removed surgically, or came back after treatment. The growth of their cancers is also fueled by the male hormone testosterone.

Darolutamide works against cancer by blocking the effects of androgen (a male reproductive hormone). Leuprolide acetate reduces the amount of certain hormones in the body. Giving darolutamide with leuprolide acetate may help stop or shrink the growth of tumor cells that need androgens to grow. Darolutamide is taken orally (by mouth) and leuprolide acetate is given as an injection.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have salivary gland cancer that cannot be removed with surgery, has spread, or came back after treatment.
  • Have salivary gland cancer that is fueled by testosterone.
  • Have recovered from the serious side effects of prior cancer therapies.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.


For more information and to see if you can join this study, please contact Dr. Alan Ho’s office at 646-608-3774.




Phase II (phase 2)

Disease Status

Relapsed or Refractory



ClinicalTrials.gov ID