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

Darolutamide monotherapy group: Objective response rate(ORR) assessed by investigators

Time frame · Up to 13 month

The proportion of patients with confirmed tumor response of complete response (CR) or partial response (PR) per RECIST 1.1, as assessed by investigators

Darolutamide and Goserelin combination therapy group: Objective response rate(ORR) assessed by an Independent Review Committee

Time frame · Up to 13 month

The proportion of patients with confirmed tumor response of CR or PR per RECIST 1.1, as assessed by an independent review committee

Duration of Response (DOR)

Time frame · Up to 13 month

DOR will be defined among responders from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease as defined in RECIST version 1.1 or death, whichever occurred first.

Best Overall Response (BOR)

Time frame · Up to 13 month

BOR will be defined as the best response recorded from the start of protocol treatment based on RECIST version 1.1

Disease Control Rate (DCR)

Time frame · Up to 13 month

DCR will be defined as the percentage of participants who achieved a confirmed best overall response of CR, PR, or SD for at least 6 weeks based on RECIST version 1.1.

Clinical Benefit Rate (CBR)

Time frame · Up to 13 month

CBR will be defined as the percentage of participants who achieved a confirmed best overall response of CR, PR, or stable disease (SD) for at least 24 weeks based on RECIST version 1.1.

Clinical Benefit Duration (CBD)

Time frame · Up to 13 month

CBD will be defined the period starting from the date of enrollment (start of treatment) and ending on the earlier of the date of determination of progression, the date of death from any cause, or the end of the study period.

Progression-Free Survival (PFS)

Time frame · Up to 13 month

PFS will be defined as the time from the date of the initial dose of study intervention to the date of first documented disease progression as defined in the RECIST version 1.1, or death due to any cause, whichever occurred first.

Overall Survival (OS)

Time frame · Up to 13 month

OS will be defined as the time from the date of the initial dose of study intervention to the date of the participant's death

Adverse events

Time frame · Up to 30 days after the last dose

All adverse events, adverse events with undeniable causal relationship to the investigational drug, severe adverse events (SAEs) and SAEs with undeniable causal relationship to the investigational drug will be evaluated based on CTCAE version 5.0

Quality of Life assessed using the EuroQol-5Dimention-5Level (EQ-5D-5L) questionnaire

Time frame · Up to 30 days after the last dose

Changes from baseline to each time point in health-related quality of life will be measured using the European Quality of Life Five Dimension Five Level Scale Assessment Questionnaire (EQ-5D-5L). The EQ-5D-5L consists of a description and a health assessment. The health description consists of five dimensions (mobility, self-care, normal activities, pain / discomfort, and anxiety / depression), with each dimension identifying five levels of severity \[best (1) - worst (5)\]. Health assessment is assessed using a visual analogue scale (VAS)(\[worse (0) - better (100)\].

Darolutamide monotherapy group: ORR assessed by an Independent Review Committee

Time frame · Up to 13 month

The proportion of patients with confirmed tumor response of CR or PR per RECIST 1.1, as assessed by an independent review committee