Uveal MelanomaPhase 2O-Mel-SoraNCT02517736
Study Multicentre Evaluating the Effectiveness and Toxicity Sorafenib (Nexavar®) in Adult Patients With Uveal Melanoma and Metastatic Dissemination
A Phase 2 study testing Sorafenib at a dose of 800 mg / day in people with Uveal Melanoma, run by University Hospital, Caen at 1 site in France.
Trial summary
The objective of the study is to determine the efficacy and toxicity of sorafenib in metastatic uveal melanoma. The main objective is to determine the non-tumor progression rate 24 weeks after initiation of treatment with sorafenib at a dose of 800 mg / day Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- Sorafenib at a dose of 800 mg / day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to 13 Jan 2015
- 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
- Male or female over 18 years old suffering from uveal melanoma with metastasis
- At least one measurable metastases by more than 10 mm acoording to Response Evaluation Criteria in Solid Tumors (RECIST)
- At least 28 days from the previous treatment (systemic or major surgery)
- Performance Index (WHO ≤ 2 or ≥ 70% Karnofsky)
- Weight loss compared to pre morbid weight <20% in the last 12 months
- White blood cells at least 3000 / mm 3, polynuclear neutrophils less than 1500 / mm3, platelets at least 100,000 / mm3, hemoglobin at least 9.0 g / dl
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- Total Bilirubin ≤1.5 x upper limit of normal (ULN) (or less than or equal to 2.5 in liver metastasis), ASAT and ALAT ≤ 2.5 x ULN (or ≤ 5 in liver metastasis) Serum Creatinine (calculated using the cockcroft-Gault method) ≤ 1.5 x ULN, Amylase and lipase <1.5 x ULN
- prothrombin rate and international normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. Possibility of using low molecular weight heparin in place of anti vitamin K treatment
- higher life expectancy than or equal to 3 months
- Negative pregnancy test for women of childbearing age and using a method of contraception during treatment
- No one benefiting from a Social Security scheme
- Informed consent and signed by the patient or his legal representative
Who cannot join
- • Patient who received more than 2 lines of treatment (chemotherapy or immunotherapy), whatever the indication
- Major surgery (excluding the possible diagnostic biopsy) or radiation therapy in the 4 weeks preceding the inclusion
- single liver metastasis treatable by surgery
- active peptic ulcer, uncontrolled
- Other progressive malignancy or during treatment (except basal cell carcinoma)
- Cardiac arrhythmias requiring anti-arrhythmic (excluding beta-blockers or digoxin for chronic atrial fibrillation), active or ischemic coronary disease (myocardial infarction within the last 6 months), or heart failure> New York Heart Association (NYHA) class II
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- Bacterial or fungal infection active (grade> 2 Common Toxicity Criteria for Adverse Effects (CTCAE) v4.03)
- known HIV infection or chronic hepatitis B or C
- cerebral or meningeal tumor metastasis (symptomatic or asymptomatic)
- epileptic disease requiring anti-epileptic taken
- Previous history of organ transplantation or peripheral stem cells
- Patient kidney dialysis
- Concomitant treatment with cytochrome P450 3A4 (CYP3A4) inducers such as rifampin, St. John's wort, phenytoin, carbamazepine, phenobarbital and dexamethasone
- Prior therapy with bevacizumab or other targeted therapy
- Known or suspected allergy to sorafenib
- Any unstable chronic illness can jeopardize patient safety or its compliance
- Women pregnant or lactating
- coagulopathy
- Uncontrolled hypertension
- Inability to swallow
- Failure to submit to medical monitoring of the trial due to geographical, social or psychic
- Persons deprived of liberty or under supervision
- Patient refusing ambulatory care
- Patient simultaneously participating in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to determine the efficacy and toxicity of sorafenib in metastatic uveal melanoma.
The main objective is to determine the non-tumor progression rate 24 weeks after initiation of treatment with sorafenib at a dose of 800 mg / day
- Conditions
- Uveal Melanoma
- Being tested
- Sorafenib at a dose of 800 mg / day
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib at a dose of 800 mg / dayDrug
| Study group | Role | What they receive |
|---|---|---|
| sorafenib at a dose of 800 mg / day | Experimental | Not described Receives: Drug: Sorafenib at a dose of 800 mg / day |
What is being measured
The primary outcome is the main question the study is designed to answer.
non-tumor progression rate
with sorafenib at a dose of 800 mg / day
Measured: 24 weeks after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startFeb 2012
- Primary completion13 Jan 2015
- Study completion13 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517736
- Sponsor's protocol ID
- 09-067
- Acronym
- O-Mel-Sora
- Status last verified
- Jan 2017
- First submitted
- 5 Aug 2015
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mouriaux F, Servois V, Parienti JJ, Lesimple T, Thyss A, Dutriaux C, Neidhart-Berard EM, Penel N, Delcambre C, Peyro Saint Paul L, Pham AD, Heutte N, Piperno-Neumann S, Joly F. Sorafenib in metastatic uveal melanoma: efficacy, toxicity and health-related quality of life in a multicentre phase II study. Br J Cancer. 2016 Jun 28;115(1):20-4. doi: 10.1038/bjc.2016.119. Epub 2016 Jun 2.
PubMed 27253171
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Multicentre Evaluating the Effectiveness and Toxicity Sorafenib (Nexavar®) in Adult Patients With Uveal Melanoma and Metastatic Dissemination
- ClinicalTrials.gov ID
- NCT02517736
- Acronym / sponsor ID
- O-Mel-Sora / 09-067
- Conditions
- Uveal Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- 13 Jan 2015 (actual)
- Study completion
- 13 Jan 2015 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to determine the efficacy and toxicity of sorafenib in metastatic uveal melanoma.
The main objective is to determine the non-tumor progression rate 24 weeks after initiation of treatment with sorafenib at a dose of 800 mg / day
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sorafenib at a dose of 800 mg / day | Experimental | Drug: Sorafenib at a dose of 800 mg / day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female over 18 years old suffering from uveal melanoma with metastasis
- At least one measurable metastases by more than 10 mm acoording to Response Evaluation Criteria in Solid Tumors (RECIST)
- At least 28 days from the previous treatment (systemic or major surgery)
- Performance Index (WHO ≤ 2 or ≥ 70% Karnofsky)
- Weight loss compared to pre morbid weight <20% in the last 12 months
Key exclusion criteria (24 listed)
- • Patient who received more than 2 lines of treatment (chemotherapy or immunotherapy), whatever the indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sorafenib at a dose of 800 mg / day | Drug | sorafenib at a dose of 800 mg / day |
Primary outcome
non-tumor progression rate
Time frame: 24 weeks after initiation of treatment
with sorafenib at a dose of 800 mg / day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Results publication: PubMed 27253171Mouriaux F, Servois V, Parienti JJ, Lesimple T, Thyss A, Dutriaux C, Neidhart-Berard EM, Penel N, Delcambre C, Peyro Saint Paul L, Pham AD, Heutte N, Piperno-Neumann S, Joly F. Sorafenib in metastatic uveal melanoma: efficacy, toxicity and health-related quality of life in a multicentre phase II study. Br J Cancer. 2016 Jun 28;115(1):20-4. doi: 10.1038/bjc.2016.119. Epub 2016 Jun 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib at a dose of 800 mg / day in people with Uveal Melanoma, run by University Hospital, Caen at 1 site in France.
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 12 inclusion and 24 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
non-tumor progression rate (time frame: 24 weeks after initiation of treatment). 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 NCT02517736, 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 17 Feb 2026.