Microarray Prediction of Response to Nivolumab, Ipilimumab, or Combined Therapy in Subjects With Previously Untreated, Locally Advanced or Metastatic Melanoma (RATIO)
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|ClinicalTrials.gov Identifier: NCT02700971|
Recruitment Status : Recruiting
First Posted : March 7, 2016
Last Update Posted : August 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Procedure: Molecular Microscope Diagnostic system||Not Applicable|
The trial treatment will consist of a pretreatment 18 gauge core biopsy of locally advanced or metastatic cutaneous or subcutaneous lesions. The biopsies will be stabilized on site in RNAlater and shipped to ATAGC by courier at ambient temperature. RNA will be extracted using Trizol-chloroform method and purified using RNAEasy micro kit (Qiagen). RNA samples passing the quality control test (Agilent Bioanalyzer) will be labeled, hybridized to PrimeView Affymetrix microarrays and scanned according to the manufacturer's protocol. Resulting ".CEL" files will be used for the analysis of the global gene expression.
Pathogenesis Based Transcript (PBT) sets that represent molecular signatures of inflammation will be assessed in core biopsies from melanoma patients. Each PBT set gets a "score" - a summarized expression of all members of a set. PBT scores allow an estimate of pre and post-treatment immunological activity in each tumor e.g. TCMR activity or macrophage burden. PBT scores will be correlated with clinical outcome to determine the utility of this technology as a prognostic and predictive biomarker. Finally a molecular classifier predicting the response to therapy will be built.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Rational Approach To Immuno-Oncology Microarray Prediction of Response to Nivolumab, Ipilimumab, or Combined Therapy in Subjects With Previously Untreated, Locally Advanced or Metastatic Melanoma|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2019|
Experimental: Cutaneous Biopsy for microarray analysis
To determine whether outcomes improve as a function of anti-tumor immunity which may enable the use of this technique as a predictive biomarker of treatment response.
Procedure: Molecular Microscope Diagnostic system
Consented patients with locally advanced or metastatic melanoma with This trial will utilize a Molecular MicroscopeTM diagnostic system (MMDxTM) that combines the molecular and histopathological features of biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. This MMDxTM will be utilized to phenotype cutaneous melanoma biopsy samples to detect an immune responsive mRNA signature.
- Correlation of the MMDx from pretreatment biopsy with overall response rate (ORR). [ Time Frame: 24 months ]
- Progression Free Survival (PFS) [ Time Frame: 24 months ]
- Overall Survival (OS) [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700971
|Contact: Michael Smylie, MB, FRCPC||780-432-8757|
|Contact: Suzanne Marneyfirstname.lastname@example.org|
|Cross Cancer Institute||Recruiting|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Contact: Michael Smylie, M.D. 780-432-8757 email@example.com|
|Principal Investigator: Michael Smylie, M.D.|
|Principal Investigator:||Michael Smylie, MB, FRCPC||Alberta Health Services|