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Ocular MelanomaPhase 2NADOMNCT05187884

Neoadjuvant/Adjuvant Trial of Darovasertib in Ocular Melanoma

A Phase 2 study testing Darovasertib in people with Ocular Melanoma, run by St Vincent's Hospital, Sydney at 2 sites in Australia.

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

The purpose of this study is to determine the feasibility and tolerability of neo-adjuvant/adjuvant Darovasertib on uveal melanoma patients. Who is it for? Patients may be eligible to join this study with high-risk uveal melanoma and planned to undergo enucleation Study details: Eligible patients will undergo up to 4… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ocular Melanoma
What is being tested?
Darovasertib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesAustralia
Study dates
3 May 2022to 1 Nov 2025
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must be at least 18 years of age.
  • Primary diagnosis of uveal melanoma as clinically determined by the treating investigator planned for enucleation (prior plaque brachytherapy is permitted)
  • Patient is able to provide written, informed consent before initiation of any study related-procedures, and is able, in the opinion of the investigator, to comply with all the requirements of the study.
  • Life expectancy > 3 months.
  • Able to safely swallow orally administered medication.
  • Patients with a prior history of or clinically stable concurrent malignancy are eligible for enrolment provided the malignancy is clinically insignificant, no treatment is required, and the patient is clinically stable
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  • Patients with a history of squamous or basal cell carcinoma of the skin or carcinoma in the situ of the cervix may be enrolled.
  • Patients with prostate cancer with an elevated PSA not requiring treatment may be enrolled
  • Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 (Karnofsky = 70%).
  • Patient has adequate organ function at screening:
  • Absolute neutrophil count = 1500/mm3 without the use of hematopoietic growth factors
  • Platelet count = 75,000/mm3 (must be at least 2 weeks post-platelet transfusion and not receiving platelet-stimulating agents)
  • Haemoglobin = 8.0 g/dL (must be at least 2 weeks post-red blood cell transfusion and not receiving erythropoietic-stimulating agents)
  • Total bilirubin = 1.5 x the upper limit of normal (ULN).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x ULN in the absence of documented liver metastases
  • Serum albumin = 30 umol/L
  • Creatinine Clearance = 60 mL/min/1.73 m2 by Cockroft-Gault equation [Appendix 6]
  • Prothrombin time/International Normalized Ratio (INR) or partial thromboplastin time test results at screening = 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose for at least 4 weeks prior to the first dose of study drug).
  • Female patients of childbearing potential must be non-pregnant, non-lactating, and have a negative serum human chorionic gonadotropin pregnancy test result within 28 days prior to the first study drug administration.
  • Females of childbearing potential who are sexually active with a non-sterilized male partner agree to use effective methods of contraception from screening, throughout the study drug and agree to continue using such precautions for 30 days after the final dose of study drug.
  • Non-sterilized males who are sexually active with a female of childbearing potential must agree to use effective methods of contraception from Day 1 throughout the study drug and for 30 days after the final dose of study drug.

Who cannot join

  • Previous treatment with a PKC inhibitor
  • Have AEs from prior anti-cancer therapy that have not resolved to Grade =1 except for alopecia, prior peripheral neuropathy, or anaemia. Endocrinopathies resulting from previous immunotherapy are considered part of the medical history and not an AE.
  • Untreated or symptomatic malignant lesions in the central nervous system (CNS).
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) - related illness.
  • Active infection requiring therapy (except nail fungus), positive tests for Hepatitis B surface antigen (HBsAg) with detected Hepatitis B virus (HBV) DNA or positive Hepatitis C antibody with detected Hepatitis C virus (HCV) RNA.
  • Prior gastrectomy or upper bowel removal or any other gastrointestinal disorder or defect e.g., malabsorption disorder such as Crohn's disease or ulcerative colitis, that would interfere with absorption of Darovasertib.
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  • Patients who are receiving treatment with medications that cannot be discontinued prior to study entry and that are considered to be any of the following (see Appendix 4):
  • known to be strong inducers or inhibitors of CYP3A4/5
  • known to be substrates of CYP3A4/5, OAT3, OATP1B1, and MATE1/2-Kwith a narrow therapeutic index
  • Females who are pregnant or breastfeeding:
  • Women of childbearing potential must not be considering getting pregnant during the study.
  • Patients of reproductive potential (male \& female) must practice an effective method of contraception during treatment and for 30 days following the last dose of Darovasertib. Patients unwilling to do so will be excluded.
  • Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
  • History or presence of ventricular tachyarrhythmia
  • Presence of unstable atrial fibrillation (ventricular response > 100 BPM); patients with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac exclusion criteria
  • Angina pectoris or acute myocardial infarction = 6 months prior to starting study drug
  • Other clinically significant heart disease (e.g., symptomatic congestive heart failure; uncontrolled arrhythmia or hypertension; history of labile hypertension or poor compliance with an antihypertensive regimen)
  • Patients with a drug eluting stent for cardiovascular purposes placed = 6 months prior to starting study drug
  • Corrected QT interval using Fridericia's method (QTcF) > 480 msec on baseline ECG (mean of baseline values). If electrolytes are abnormal, they may be corrected, and baseline ECGs should be repeated (Appendix 5).
  • Known to have previously received Darovasertib
  • Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the opinion of the investigator, would make the patient inappropriate for entry into the study.

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Kinghorn Cancer Centre, St. Vincent's Hospital

    Sydney, New South Wales, 2010

Other trials in Australia

About this study

The purpose of this study is to determine the feasibility and tolerability of neo-adjuvant/adjuvant Darovasertib on uveal melanoma patients.

Who is it for? Patients may be eligible to join this study with high-risk uveal melanoma and planned to undergo enucleation

Read more

Study details:

Eligible patients will undergo up to 4 weeks of treatment with Darovasertib (300mg, twice a day as a starting dose) and once determiend safe then up to 6 months after fulfilling inclusion/exclusion criteria and consent. Select patients will undergo adjuvant treatment for 6 months based on their initial response.

It is hoped that this research will provide insight into the safety and tolerability of Darovasertib. Furthermore, it aims to document the pharmacodynamic and pharmacokinectic effects of Darovasertib on uveal melanoma patients.

Conditions
Ocular Melanoma
Being tested
Darovasertib
Medical subject headings
Uveal Melanoma

What participants receive

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

  • DarovasertibDrug

    Oral Darovasertib 300 mg tablets twice daily

Study groups in NCT05187884
Study groupRoleWhat they receive
InterventionExperimentalDarovasertib 300mg bd
Receives: Drug: Darovasertib

What is being measured

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

  1. To determine the safety of a up to a 56-day course of Darovasertib via clinical assessment by CTCAE v5.0 guidelines for adverse event(s)

    Safety Profile

    Measured: 56 days post commencement of investigational product.

  2. Percentage of participants that complete the 56-day treatment period.

    Measured: 56 days post commencement of investigational product.

Secondary outcomes (2)

  1. To determine the effect of neo-adjuvant Darovasertib on tumour size in uveal melanoma as measured by ocular ultrasound.

    Measured: 56 days

  2. To explore time to recurrence/disease-specific survival in patients on adjuvant Darovasertib assessed by standard of care imaging measured using RECIST 1.1.

    Measured: 5 years

Timeline

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

  1. First posted12 Jan 2022
  2. Study start3 May 2022
  3. Primary completion1 Jan 2025
  4. Study completion1 Nov 2025

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05187884
Sponsor's protocol ID
NADOM
Acronym
NADOM
Status last verified
Jun 2025
First submitted
9 Dec 2021
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No Plan to share participant data with individuals outside this trial

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Darovasertib in people with Ocular Melanoma, run by St Vincent's Hospital, Sydney at 2 sites in Australia.

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 21 inclusion and 21 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 23 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 2 sites in Australia. 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?

To determine the safety of a up to a 56-day course of Darovasertib via clinical assessment by CTCAE v5.0 guidelines for adverse event(s) (time frame: 56 days post commencement of investigational product.). 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 NCT05187884.

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 23 Apr 2026.

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