RATIO: Rational Approach To Immuno-Oncology

NCT02700971 | Completed

• 1 other identifier: IIT-RATIO-CCI-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

• Correlation of the MMDx from pretreatment biopsy with overall response rate (ORR).

  24 months

Secondary Outcomes (2)

• Progression Free Survival (PFS)

  24 months

• Overall Survival (OS)

  24 months

Study Arms (1)

Cutaneous Biopsy for microarray analysis

EXPERIMENTAL

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

Interventions

Molecular Microscope Diagnostic system PROCEDURE

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.

Cutaneous Biopsy for microarray analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, \> 18 years of age
• Histologically confirmed locally advanced or metastatic melanoma with cutaneous or subcutaneous lesions
• Immunotherapy treatment naïve subjects (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma)
• Scheduled to receive ipilimumab, nivolumab, or combination treatment
• Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2
• Not pregnant or lactating. Women who are of child-bearing potential must agree to use an effective means of birth control (i.e., latex condom, diaphragm, cervical cap, etc) to avoid pregnancy.
• Informed consent for microarray analysis of locally advanced lesion or skin metastasis retrieved by standard of care biopsy

You may not qualify if:

• Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co- stimulation or immune checkpoint pathways
• Subjects with active, known, or suspected autoimmune disease
• If considered high-risk and tested for hepatitis: Any positive test result for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
• Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
• Any significant medical condition, laboratory abnormality, or psychiatric illness, that would prevent the subject from participating in the study, places the subject at unacceptable risk if he/she were to participate in the study, or any condition that confounds the ability to interpret data from the study

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Transplant Genomics, Inc.: collaborator

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael Smylie, MB, FRCPC

  Alberta Health services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 7, 2016
• Study Start: June 23, 2016
• Primary Completion: June 1, 2022
• Study Completion: September 8, 2023
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)