Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY)

Prior treatment

• Prior treatment with AR inhibitors, CYP17 enzyme inhibitors, or LH-RH analogue.
• Severe or uncontrolled concurrent heart disease or hypertension.
• Inability to swallow oral medications.
  • Darolutamide and Goserelin combination therapy group:
• Prior treatment with AR inhibitors, CYP17 enzyme inhibitors, LH-RH analogue, Sex Hormones, or Gonadotropin
• Prior treatment with Darolutamide or Goserelin.
• Severe or uncontrolled concurrent heart disease or hypertension.

Other illness

• Synchronous or metachronous malignancies.
• Participant has a known history of HIV infection.
• A positive test result for any of the followings:
  • HBsAg positive
  • HBsAb positive and hepatitis B virus (HBV)-DNA positive
  • HBcAb positive and HBV-DNA positive
• Synchronous or metachronous malignancies.
• Participant has a known history of HIV infection.
• A positive test result for any of the followings:
  • HBsAg positive
  • HBsAb positive and HBV-DNA positive
  • HBcAb positive and HBV-DNA positive

Lab values

• Histologically confirmed as androgen receptor-negative salivary gland carcinoma at a central laboratory.

Other

• Darolutamide monotherapy group:
• Metastases in the brain/central nervous system (CNS).
• Patients who are pregnant or breastfeeding.
• Metastases in the brain/CNS.
• Patients who are pregnant or breastfeeding.
• Inability to administer Darolutamide or Goserelin.

• Darolutamide monotherapy group:
• Signed, written informed consent.
• Patients older than 20 years.
• Histologically confirmed any salivary duct carcinoma (SDC), adenocarcinoma (AC)(NOS), or Carcinoma ex pleomorphic adenoma.
• Patients with locally recurrent(unresectable) or metastatic salivary gland carcinoma who are not applied for surgery or radiation treatment.
• Presence of measurable or evaluable disease according to RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Adequate organ or bone marrow function
• Patients who agree to practice effective barrier contraception and refrain from sperm donation during the entire study treatment period and 3 months after the last dose of the study drug.
  • Darolutamide and Goserelin combination therapy group:
• Signed, written informed consent.
• Patients older than 20 years.
• Histologically confirmed as androgen receptor-positive salivary gland carcinoma at the medical institution.
• Histologically confirmed as salivary gland carcinoma at the medical institution.
• Patients with locally recurrent(unresectable) or metastatic salivary gland carcinoma who are not applied for surgery or radiation treatment.
• Presence of measurable or evaluable disease according to RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Adequate organ or bone marrow function
• Patients who agree to practice effective barrier contraception refrain from sperm donation and stop breastfeeding during the entire study treatment period and through 3 months after the last dose of the study drug.