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מחקרים קליניים

שיבא מכון אלה | מחקרים קליניים

Ongoing clinical studies at the Ella institute

 

 A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs  Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma

This study is ongoing, but not recruiting participants.

 

Detailed Description

Eligible patients will have a 66% chance of receiving Allovectin-7® alone
(an investigational product designed to train your body's immune system to recognize and destroy tumor cells) vs. a 33% chance of receiving standard chemotherapy (either dacarbazine or temozolomide). The treatment course recommended for patients who receive Allovectin-7® is a minimum of 16 weeks. Each cycle will consist of weekly injections of Allovectin-7® alone for six weeks followed by two weeks of observation and assessments. For patients who receive the chemotherapy alone, their treatment course will follow standard dosing. During the trial all patients' tumors will be closely monitored. Patients whose melanoma does not clinically progress will be encouraged to continue on the treatment and be assessed for up to two years

 

 A Phase III Study to Test the Benefit of a New Kind of Anti cancerTreatment in Patients With Melanoma,
After Surgical Removal of Their Tumor
This study is ongoing, but not recruiting participants.

 

Detailed Description http://www.immunotherapyforcancer.info provides information on the "cancer immunotherapeutic approach in an easy-to-understand format". http://www.ascitrials.com "gives practical information on the MAGRIT clinical study"

 

   

A Study of RO5185426 in Comparison With Dacarbazine in Previously

Untreated Patients With Metastatic Melanoma

This study is ongoing, but not recruiting participants.

 

 

Purpose

This randomized, open-label study will evaluate the efficacy, safety and tolerability of RO5185426 as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients will be randomized to receive either RO5185426 [RG7204; PLEXXIKON: PLX4032] 960 mg orally twice daily or dacarbazine 1000mg/m2 intravenously every 3 weeks. Anticipated time on study treatment is until disease progression or unacceptable toxicity. Target sample size is 500-1000 individuals

 

 

 

 

   Adoptive Cell Therapy Following Non-Myeloablate Chemotherapy in Metastatic Melanoma Patients

This study is currently recruiting participants.

Purpose

Metastatic melanoma is an aggressive and highly malignant cancer. The five-year survival rate of patients with metastatic disease is less than 5% with a median survival of only 6-10 months. Drugs like Dacarbazin (DTIC) as a single agent or in combination with other chemotherapy agents, have a response rate of 15-30%, but the duration of response is usually short, with no impact on survival. Interleukin-2 (IL-2) based immunotherapy has shown more promising results. This form of therapy has a similar response rate with some patients achieving a durable complete response. Recently the National Institute of Health (NIH) reported that by using lympho-depleting chemotherapy, followed by an adoptive transfer of large numbers of anti-tumor specific tumor-infiltrating lymphocytes (TIL), an objective regression was achieved in 51% of patients with metastatic melanoma

 

   Compassionate Use Trial for Unresectable Melanoma With Ipilimumab

This study is ongoing, but not recruiting participants.

Purpose

 

The primary objective of the study is to provide treatment with ipilimumab to subjects who have serious or immediately life-threatening unresectable Stage III or Stage IV melanoma, who have no alternative treatment options, and whose physicians believe, based upon available data on benefit and risk, that it is appropriate to administer ipilimumab for eligible subjects, including those previously enrolled in ipilimumab studies MDX010-16 or MDX010-20

 

A Study of RO5185426 in Patients With Metastatic Melanoma

This study is ongoing, but not recruiting participants.

Purpose

 

This is an open-label, non-comparative, multicenter, expanded access study of RO5185426 in patients who have received prior systemic therapy for metastatic melanoma and who have no other satisfactory treatment options.

A Study of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases This study is currently recruiting participants.
(End of requirement Feb 2013)
Purpose

 

This open-label, single-arm, multicenter study will evaluate the efficacy and safety in patients with metastatic melanoma who developed brain metastases. Patients may or may not have received prior treatment for metastatic melanoma with brain metastases (except treatment with BRAF or MEK inhibitors). Patients will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.

 

 

A multicenter study to asses the safety of Vismodegib (GDC-0449) in Patients with locally advanced or metastatic Basal cell Carcinoma  

 

This study is currently recruiting participants

Purpose

This is an open-label, non-comparative, multicenter, phase II study of vismodegib in patients with locally advanced BCC or metastatic BCC who are otherwise without satisfactory treatment options.

 

A study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to the BRAF inhibitor vemurafenib in subjects with unresectable (stage IIIc) or metastatic (stage IV) BRAF V600E/K mutation positive cutaneous melanoma

This study is currently recruiting participants

Purpose

The purpose of this study is to test the safety of dabrafenib, which targets the BRAF gene and trametinib which aims at a different cell signalling gene called MEK and see how well they work together compared to another drug vemurafenib, also known as Zelboraf® which also targets the BRAF gene.

 

 

A study of MK-3475 (Humanized IgG4 Anti-PD1 Monoclonal Antibody) versus Chemotherapy in patient with advanced Melanoma

This study is currently recruiting participants

Purpose

The indication is for Patients with advanced melanoma refractory to Ipilimumab. Patients with BRAF V600E mutant melanoma must have also been previously treated with a BRAF and/or MEK inhibitor

    The current study will examine the efficacy of 2 mg/kg of MK-3475 and 10 mg/kg of

    MK-3475 Q3W versus chemotherapy (treatment of Investigator choice) in patients

    with advanced MEL who are refractory to ipilimumab. Patients with BRAF V600E mu

    MEL have also been previously treated with a BRAF and/or MEK inhibitor.

    Chemotherapy choices to be delivered according to standard of care (SOC) or

    current clinical practice for the treatment of MEL are carboplatin plus paclitaxel,

    carboplatin alone, paclitaxel alone, dacarbazine (DTIC), and temozolomide

 

 

  A multicentre, open label, randomized Phase II trial of the MEK inhibitor

  pimasertib or dacarbazine in previously untreated subjects with NRas mutated

  locally advanced or metastatic malignant cutaneous melanoma

 

This study is currently recruiting participants

Purpose

This study is a phase II, multicentre, randomized,  controlled pimasertib versus dacarbazine (2 vs. 1), open label trial. The aim of the trial is to confirm the activity of

pimasertib in previously untreated subjects with locally advanced or metastatic N-Ras mutated malignant cutaneous melanoma and to quantify it versus dacarbazine. Secondary aims of the trial are to get a better understanding of the efficacy, safety, harmacogenomics

(PGx) and their relationship with pimasertib exposure. Subjects progressing in the dacarbazine arm will be proposed pimasertib treatment (switch).

 

JAN 2013