Clinical Trials Logo
  1. Home
  2. Ocular Melanoma
  3. NCT01893099

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

Ocular Melanoma Clinical Trial

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

Clinical 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 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01893099
Study type Interventional
Source Centre Hospitalier Universitaire Vaudois
Contact
Status Completed
Phase Phase 1
Start date June 2013
Completion date November 28, 2017
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04364230 - Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma) Phase 1/Phase 2
Completed NCT01200238 - STA-9090(Ganetespib) in Metastatic Ocular Melanoma Phase 2
Completed NCT02858869 - Pembrolizumab and Stereotactic Radiosurgery for Melanoma or Non-Small Cell Lung Cancer Brain Metastases Phase 1
Completed NCT01355120 - THE IPI - Trial in Advanced Melanoma: Melanoma Patients With Advanced Disease Phase 2
Recruiting NCT05524935 - Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma Phase 2
Recruiting NCT05628883 - Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma Phase 1
Active, not recruiting NCT05187884 - Neoadjuvant/Adjuvant Trial of Darovasertib in Ocular Melanoma Phase 2
Recruiting NCT02909517 - The Role of Inflammation in Ocular Tumours
Withdrawn NCT00621439 - Investigative Trial of Interferon Alpha-2b To Shrink Cancer of the Eye N/A
Terminated NCT00346372 - Optical Coherence Tomography of Retinal Abnormalities Associated With Choroidal Nevus, Choroidal Melanoma and Choroidal Melanoma Treated With Iodine-125 Brachytherapy
Recruiting NCT03172299 - Prevention of Neovascular Glaucoma by Intravitreal Injections of Anti-VEGF in Patients Treated With Proton Therapy for a Large Choroidal Melanoma Phase 3
Not yet recruiting NCT06432660 - Eye Plaque Brachytherapy for Ocular Melanoma
Completed NCT00351728 - Combined PET/CT Imaging for the Early Detection of Ocular Melanoma Metastasis Compared to CT Scanning Alone N/A
Active, not recruiting NCT03528408 - Study of Adjuvant Ipilimumab and Nivolumab in Subjects With High-risk Ocular Melanoma Phase 2
Completed NCT03052127 - Study in Subjects With Small Primary Choroidal Melanoma Phase 1/Phase 2
Withdrawn NCT01930968 - Definity for Ultrasound of Intraocular Tumors
Recruiting NCT00168870 - Study of Metastatic Ocular Melanoma Phase 2
Completed NCT02519322 - Neoadjuvant and Adjuvant Checkpoint Blockade Phase 2
Recruiting NCT06007690 - A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma Phase 3
Active, not recruiting NCT04417530 - Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma Phase 2