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Salivary Gland CancerPhase 2NCT05694819

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

A Phase 2 study testing Darolutamide and Goserelin in people with Salivary Gland Cancer, run by National Cancer Center Hospital East at 12 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is an open-label phase 2 study to evaluate the safety and efficacy of Darolutamide monotherapy in patients with androgen receptor-positive salivary gland carcinoma. Moreover, this study will evaluate the safety and efficacy of Darolutamide and Goserelin combination in patients with androgen… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Salivary Gland Cancer
What is being tested?
Darolutamide and Goserelin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
12 sitesJapan
Study dates
17 Apr 2020to 23 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • Darolutamide monotherapy group:
  • Histologically confirmed as androgen receptor-negative salivary gland carcinoma at a central laboratory.
  • Prior treatment with AR inhibitors, CYP17 enzyme inhibitors, or LH-RH analogue.
  • Metastases in the brain/central nervous system (CNS).
  • Patients who are pregnant or breastfeeding.
  • Synchronous or metachronous malignancies.
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  • 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
  • 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.
  • Metastases in the brain/CNS.
  • Patients who are pregnant or breastfeeding.
  • 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
  • Severe or uncontrolled concurrent heart disease or hypertension.
  • Inability to administer Darolutamide or Goserelin.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Japan12 sites

  • Chiba University Hospital

    Chiba, Chiba, 260-8677

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • The Jikei University Hospital

    Tokyo, Tokyo, 105-0003

  • Tokyo Medical And Dental University Hospital

    Tokyo, Tokyo, 113-8519

  • Tokyo Medical University Hospital

    Tokyo, Tokyo, 160-0023

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

About this study

Official title: Phase II Study of Darolutamide (ODM-201) in Patients With Androgen Receptor-positive Salivary Gland Carcinoma (Discovary Study)

This study is an open-label phase 2 study to evaluate the safety and efficacy of Darolutamide monotherapy in patients with androgen receptor-positive salivary gland carcinoma. Moreover, this study will evaluate the safety and efficacy of Darolutamide and Goserelin combination in patients with androgen receptor-positive salivary gland carcinoma.

Being tested
Darolutamide, Goserelin
Keywords
Androgen receptor (AR)-positive, Salivary gland carcinoma, Darolutamide, luteinizing hormone-releasing hormone (LH-RH) analogue
Medical subject headings
Salivary Gland Neoplasms, Bulbo-Spinal Atrophy, X-Linked

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DarolutamideDrug

    Darolutamide at a dose of 600 mg (2 tablets of 300 mg) twice daily with food (equivalent to a daily dose of 1200 mg) will be administered orally.

  • GoserelinDrug

    Goserelin at a dose of 3.6 mg will be administered subcutaneously every 4 weeks.

Study groups in NCT05694819
Study groupRoleWhat they receive
Darolutamide monotherapyExperimentalTargeted patients: 24
Receives: Drug: Darolutamide
Darolutamide plus GoserelinExperimentalTargeted patients: 32
Receives: Drug: Darolutamide; Drug: Goserelin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Up to 13 month

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

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

    Measured: Up to 13 month

Secondary outcomes (13)

  1. Duration of Response (DOR)

    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.

    Measured: Up to 13 month

  2. Best Overall Response (BOR)

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

    Measured: Up to 13 month

  3. Disease Control Rate (DCR)

    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.

    Measured: Up to 13 month

  4. Clinical Benefit Rate (CBR)

    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.

    Measured: Up to 13 month

  5. Clinical Benefit Duration (CBD)

    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.

    Measured: Up to 13 month

  6. Progression-Free Survival (PFS)

    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.

    Measured: Up to 13 month

  7. Overall Survival (OS)

    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

    Measured: Up to 13 month

  8. Adverse events

    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

    Measured: Up to 30 days after the last dose

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

    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)].

    Measured: Up to 30 days after the last dose

  10. Darolutamide monotherapy group: ORR assessed by an Independent Review Committee

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

    Measured: Up to 13 month

  11. Darolutamide and Goserelin combination therapy group: ORR assessed by investigators

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

    Measured: Up to 13 month

  12. Comparison of androgen receptor (AR) test results in Darolutamide and Goserelin combination therapy group

    Comparison of AR test results between each institutional and a central assessment

    Measured: Baseline

  13. Positivity of Ki-67 in Darolutamide and Goserelin combination therapy group

    The proportion of patients who have high expression of Ki-67 by a central assessment

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2023
  2. Study start17 Apr 2020
  3. Primary completion9 Aug 2024
  4. Study completion23 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05694819
Sponsor's protocol ID
YCU19003
Other IDs
jRCT2031190241
Status last verified
Apr 2026
First submitted
12 Jan 2023
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Okano S, Tahara M, Tsukahara K, Otsuka T, Kano S, Nagaoka M, Uryu H, Sano D, Nishio N, Ono K, Ohkoshi A, Hanazawa T, Shinoda S, Takeda Y, Yamamoto K, Kiyota N. Darolutamide Alone and in Combination With Goserelin in Androgen Receptor-Positive Salivary Gland Carcinoma: Results From the Phase II DISCOVARY Trial. J Clin Oncol. 2026 Sep 20;44(27):2602-2613. doi: 10.1200/JCO-25-03028. Epub 2026 Aug 3.

    PubMed 42546251

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Darolutamide and Goserelin in people with Salivary Gland Cancer, run by National Cancer Center Hospital East at 12 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Darolutamide monotherapy group: Objective response rate(ORR) assessed by investigators (time frame: Up to 13 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05694819, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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