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Testing roginolisib for advanced uveal melanoma

A Phase II, Multi-centre, Open Label, Randomised Study to Evaluate the Anti-tumour Activity of Roginolisib in Patients With Advanced/Metastatic Ocular/Uveal Melanoma

Phase 2 Interventional iOnctura · NCT06717126

This study is testing if a new oral medication called roginolisib can help adults with advanced uveal melanoma live longer and feel better compared to standard treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment85 (estimated)
Ages18 Years and up
SexAll
SponsoriOnctura Industry-sponsored
Drugs / interventionsimmunotherapy
Locations16 sites (Bari and 15 other locations)
Trial IDNCT06717126 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of roginolisib, an oral medication, compared to standard treatment in adult patients with advanced or metastatic uveal melanoma. It is a Phase II open-label, randomized study that will enroll approximately 85 participants who have experienced disease progression after at least one prior immunotherapy. The trial aims to determine if roginolisib can extend overall survival and improve quality of life compared to existing therapies. Patients will undergo assessments to measure disease progression and treatment response.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with advanced or metastatic uveal melanoma who have progressed after at least one prior immunotherapy treatment.

Not a fit: Patients with early-stage uveal melanoma or those who have not received prior immunotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option that improves survival and quality of life for patients with advanced uveal melanoma.

How similar studies have performed: While there have been studies on treatments for uveal melanoma, the specific approach of using roginolisib is novel and has not been extensively tested in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female aged 18 years or older;
2. Histologically or cytologically proven diagnosis of advanced or metastatic UM or ocular melanoma (arising from ocular melanocytes regardless of intraocular location)
3. Patients who have progressed following at least 1 prior immunotherapy treatment for advanced or metastatic UM. For patients who are HLA-A\*02:01 positive prior treatment should have included tebentafusp, if available or patients clinically suitable. Patients who have also received prior melphalan hepatic infusion may be included;
4. Presence of at least one lesion suitable for biopsy. Biopsies will be mandatory at Screening and C5D1 (see Sections 8.1.3 and 8.6 for more information);
5. Presence of at least one measurable lesion as per RECIST v1.1. Any lesion that is biopsied cannot be used as a measurable lesion for the purposes of RECIST v1.1 assessments;
6. ECOG performance status of 0 to 1;
7. Male or female patients of child-bearing potential must be willing to use highly effective forms of contraception (refer to APPENDIX 7 for details on highly effective methods of contraception and definitions of women of childbearing potential and of fertile men)
8. All other relevant medical conditions must be well managed and stable, in the Investigator's opinion, for at least 28 days prior to first dose of roginolisib;
9. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.

Exclusion Criteria:

1. Inability to swallow oral medication;
2. a). History of a prior Grade 3 or 4 irAE or any grade ocular irAE from prior immunotherapy which did not respond to corticosteroid therapy or resolved with treatment interruptions and returned to at least Grade 1; b). Have not recovered from toxic effect(s) of prior therapy to ≤ Grade 1, other than alopecia or fatigue or neuropathy which must be ≤ Grade 1;
3. Presence of symptomatic or untreated CNS metastases or CNS metastases that require doses of corticosteroids within the prior 3 weeks to first dose of roginolisib. Patients with brain metastases are eligible if lesions have been treated with localised therapy and there is no evidence of progressive disease for at least 4 weeks prior to the first dose of IMP;
4. Abnormal liver enzymes defined as:

   1. ALT or AST ≥ 3× upper limit of normal (ULN) (≥ 5× ULN in patients with liver metastases);
   2. Total bilirubin ≥ 1.5 × ULN are excluded unless direct bilirubin is ≤ ULN. If there is no institutional ULN, then direct bilirubin must be \< 40% of total bilirubin to be eligible (except patients with Gilbert syndrome);
5. Any other clinically significant out of range laboratory values;
6. Clinically significant cardiac disease or impaired cardiac function which may limit the patient´s participation in the clinical study. These may include unstable angina (i.e., not responsive to medical intervention), myocardial infarct in last 6 months, QTcF prolongation of more than 500 ms;
7. Evidence of interstitial lung disease or active, non-infectious pneumonitis, pulmonary fibrosis;
8. Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of IMP;
9. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol;
10. Malignant disease, other than that being treated in this study (e.g., skin/cutaneous and/or mucosal melanoma). Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to first dose of IMP; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type;
11. Any medical condition that would, in the Investigator\'s or Sponsor\'s judgment, prevent the patient\'s participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results;
12. Treatment with anti-tumour medications or investigational drugs within 14 days or 5 half-lives (whichever is longer) of administration of first dose of IMP;
13. Major surgery within 2 weeks of the first dose of IMP (minimally invasive procedures such as bronchoscopy, tumour biopsy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery and are not exclusionary);
14. Radiotherapy within 4 weeks of the first dose of IMP, with the exception of palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumour mass;
15. Pregnant, likely to become pregnant, or lactating women.

Where this trial is running

Bari and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Uveal MelanomaOcular MelanomaUvealOcularMelanoma
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.