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Ocular MelanomaPhase 1NCT01893099

Sorafenib and Radioembolization With Sir-Spheres® for the Treatment of Metastatic Ocular Melanoma

A Phase 1 study testing Sorafenib and Radioembolization with SIR-Spheres® (Yttrium Microspheres) in people with Ocular Melanoma, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

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 best way to combine a loco-regional procedure such as chemoembolisation or radioembolization combined with an anti-angiogenic drug is not clear. This phase I trial aims to establish, first, the tolerability of the combination of liver radioembolization with SirSpheres® and sorafenib in uveal melanoma patients with… 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?
Sorafenib and Radioembolization with SIR-Spheres® (Yttrium Microspheres)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteSwitzerland
Study dates
Jun 2013to 28 Nov 2017
Phase
Phase 1
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

  • Metastatic uveal melanoma with proven histology (stage IV)
  • Presence of liver metastases
  • Concomitant non life-threatening metastases outside the liver are allowed
  • Palliative radiotherapy will be allowed outside the liver
  • Previous chemotherapy or immunotherapy at least 4 weeks before study treatment is allowed
  • Age ≥ 18 years
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  • ECOG Performance Status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Subjects with at least one uni-dimensional (by RECIST) measurable lesion. Lesions must be measured by CT-scan or MRI
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to study treatment
  • Hemoglobin ≥ 9.0 g/dl
  • Absolute neutrophil count (ANC) ≥ 1,500/mm3
  • Platelet count ≥ 100,000/ul
  • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
  • ALT and AST ≤ 5 x ULN
  • Alkaline phosphatase < 4 x ULN
  • PT-INR/PTT < 1.5 x ULN
  • Serum creatinine ≤ 1.5 x ULN
  • Signed and dated informed consent before the start of specific protocol procedures

Who cannot join

  • History of cardiac disease: congestive heart failure >NYHA class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
  • History of HIV infection or chronic hepatitis B or C.
  • Active clinically serious infections (> grade 2 NCI-CTC version 4.0).
  • Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks before treatment start and is clinically stable with respect to the tumor at the time of study treatment).
  • Patients with seizure disorder requiring medication (such as steroids or anti-epileptics).
  • History of organ allograft.
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  • Patients with evidence or history of bleeding diasthesis.
  • Patients undergoing renal dialysis.
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumor (Ta, Tis and T1) or any cancer curatively treated > 3 years prior to study treatment.
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test 72h before all investigations related to the protocol. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial (and men for at least 3 months after last administration of study medication).
  • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
  • Patients unable to swallow oral medications.
  • Pre-treatment with any antiangiogenic agents (Bevacizumab, Sunitinib, or other TKI inhibitors affecting the vessels)
  • Radiotherapy on the liver
  • Major surgery within 4 weeks of start of treatment
  • Autologous bone marrow transplant or stem cell rescue within 4 months of study treatment.
  • Use of biologic response modifiers, such as G-CSF, within 3 weeks of study treatment.
  • Investigational drug therapy outside of this trial during or within 4 weeks of study treatment
  • Prior exposure to the study drug
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Centre Hospitalier Universitaire Vaudois

    Lausanne

Other trials in Switzerland

About this study

The best way to combine a loco-regional procedure such as chemoembolisation or radioembolization combined with an anti-angiogenic drug is not clear. This phase I trial aims to establish, first, the tolerability of the combination of liver radioembolization with SirSpheres® and sorafenib in uveal melanoma patients with liver metastasis studying different schedules of administration of sorafenib after and before radioembolization. Secondly, we aim to evaluate angiogenic markers modifications during these different schedules, either in the serum or radiologicaly. Dose of Sorafenib will be 400 mg BID and the timing of introduction will differ for one cohort to the other, given after the radioembolization for initials cohorts and finally, before and concomitantly to radioembolization for the last cohort.

Read the detailed description

Primary objective:

To evaluate the safety and tolerability of sorafenib in combination with SIR-Spheres® radioembolization in uveal melanoma patients metastatic to the liver.

Secondary objectives:

  • Translational research on biomarkers (blood and liver biopsies) as well as on radiological exam by using microbubble contrast enhanced ultrasound. Angiogenic markers such as VEGF, IGF-2, TFG Angiopoietin-2 and IL-8 will be monitored. Correlations will be investigated between the angiogenic markers (blood \& tumor tissue), angiogenic radiological exam and the response to the treatment.
  • To evaluate the response, clinical benefit, PFS and survival of the patients.
Conditions
Ocular Melanoma
Being tested
Sorafenib, Radioembolization with SIR-Spheres® (Yttrium Microspheres)
Medical subject headings
Uveal Melanoma

What participants receive

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

  • SorafenibDrug

    Also called Nexavar®

    Sorafenib will be given at the dosage of 400 mg BID. Initiation of the drug will vary dependently of the cohort and will be continued until progressive disease or intolerance.

  • Radioembolization with SIR-Spheres® (Yttrium Microspheres)Device

Study groups in NCT01893099
Study groupRoleWhat they receive
Sorafenib- Cohort 1ExperimentalSorafenib 400 mg BID will be started 14 days after the administration of SIRT with SIR-Sphere®.
Receives: Drug: Sorafenib; Device: Radioembolization with SIR-Spheres® (Yttrium Microspheres)
Sorafenib- Cohort 2ExperimentalSorafenib 400 mg BID will be started 11 days after the administration of SIRT with SIR-Sphere®.
Receives: Drug: Sorafenib; Device: Radioembolization with SIR-Spheres® (Yttrium Microspheres)
Sorafenib- Cohort 3ExperimentalSorafenib 400 mg BID will be started 3 days after the administration of radioembolization with SIR-Sphere®.
Receives: Drug: Sorafenib; Device: Radioembolization with SIR-Spheres® (Yttrium Microspheres)
Sorafenib- Cohort 4ExperimentalSorafenib 400 mg BID will be started 7 days prior to the administration of radioembolization with SIR-Spheres® and be given continuously, without drug holidays.
Receives: Drug: Sorafenib; Device: Radioembolization with SIR-Spheres® (Yttrium Microspheres)

What is being measured

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

  1. Toxicity

    Toxicities will be assessed according to the NCI-CTCAE (version 4.0).

    Measured: 30 days of treatment of sorafenib

Secondary outcomes (4)

  1. Translational research on biomarkers

    Measurement of angiogenic factors and evaluation of angiogenesis with dynamic micro-bubble contrast-enhanced US

    Measured: 2 years

  2. Clinical benefit

    Clinical benefit (CR, PR and NC) evaluated with 18F-FDG-PET CT scan and CT scan by using respectively PERCIST criteria and RECIST criteria

    Measured: 2 years

  3. Progression-free survival (PFS)

    Measured: 2 years

  4. Overall survival (OS)

    Measured: 2 years

Timeline

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

  1. First posted8 Jul 2013 (estimated)
  2. Study startJun 2013
  3. Primary completion28 Nov 2017
  4. Study completion28 Nov 2017

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01893099
Sponsor's protocol ID
CHUV-CePO-code 16295
Status last verified
Apr 2018
First submitted
2 Jul 2013
Last updated
23 Apr 2018
Results posted
No
Data monitoring committee
No

Publications

  • Berthod G, Cisarovsky C, Petrova T, Decosterd LA, Choong E, Celestini D, Cuendet MA, Boughdad S, Prior JO, Meuwly JY, Figg WD, Michielin O, Leyvraz S. Sorafenib plus selective internal radiotherapy with 90Y resin microspheres for the treatment of uveal melanoma with liver metastasis: a phase I trial. Br J Cancer. 2026 Feb;134(4):589-597. doi: 10.1038/s41416-025-03279-9. Epub 2025 Dec 11.

    PubMed 41381843

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sorafenib and Radioembolization with SIR-Spheres® (Yttrium Microspheres) in people with Ocular Melanoma, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

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 20 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 2018. 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 Switzerland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Toxicity (time frame: 30 days of treatment of sorafenib). 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 NCT01893099, 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 23 Apr 2018.

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