Medical condition: Advanced Metastatic Ocular/Uveal Melanoma Medical condition in lay language: Eye cancer Therapeutic areas: Diseases [C] - Eye Diseases [C11] Eye Diseases
Conditions
Interventions
Patients will be in two stages i.e., will be randomised into 3 groups, as follows, in the ratio 2:1:1 according to a randomisation schedule:
• Arm 1 (Active treatment arm): Roginolisib oral tablet 80
Sponsors
iOnctura
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged over 18 years with advanced or metastatic uveal melanoma (UM) 2. Patients must have progressed following at least 1 prior immunotherapy treatment 3. The disease must be measurable (at least 1 measurable lesion) as per RECIST v1.1 by CT scan or MRI 4. All melanoma arising from melanocytes of the eye, regardless of intraocular location, will be included in the study 5. Ocular melanoma and UM are used interchangeably in the Protocol
Exclusion criteria
Exclusion criteria: Must meet all of the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) measured using data collected in medical records to evaluate the clinical efficacy of roginolisib as a single agent, against Investigator’s choice of therapy in patients followed for 24 months from the last patient enrolled | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival (PFS) measured from the date of the first dose of IMP until the earliest date of disease progression, as determined by radiographic/objective disease assessment per RECIST v1.1, every 8 weeks whilst on treatment 2. Objective response rate (ORR) defined as the percentage of patients with a Complete Response (CR) or Partial Response (PR), measured every 8 weeks whilst on treatment 3. Duration of response (DOR) defined as the time from the date of first documented response (CR, PR) by RECIST v1.1 until the date of documented progression or death in the absence of disease progression, measured every 8 weeks whilst on treatment 4. Time to response defined as the time from the date of the first dose of IMP until the date of the first documented objective response, measured every 8 weeks whilst on treatment 5. Disease control rate (DCR) defined as the proportion of patients with a Best Objective Response (BOR) of CR, PR, or Stable Disease (SD) recorded at =8 weeks (±1 week), measured every 8 weeks whilst on treatment 6. Clinical benefit rate (CBR) defined as the proportion of patients with a BOR of CR, PR, or SD recorded at Cycle 5 Day 1, measured at Cycle 5 - approximately 16 weeks from the start of dosing 7. Safety and tolerability assessed by AEs, laboratory parameters, vital signs, physical exam, ECG, and ECOG status, measured every 4 weeks whilst on treatment 8. Pharmacokinetics measured by the concentration of roginolisib at pre-dose and steady-state levels (including Area under the curve [AUC], population PK), every 4 weeks for 12 months from the start of treatment 9. Quality of Life measured by changes in PRO relative to baseline, every 4 weeks for 12 months from the start of treatment 10. Safety of 40 vs 80 mg of roginolisib assessed by AEs, laboratory parameters, vital signs, physical exam, ECG, and ECOG status, measured every 4 weeks whilst on treatment 11. Health care utilisation assessed by health resource use (e.g., hospitalisatio | — |
Countries
Italy, Spain, United Kingdom
Contacts
Public ContactMichael Lahn
Outcome results
None listed