Molecular Disease Characterization Initiative (MDCI)

Neoplasms Clinical Trial

Official title:

A Global, Molecular Disease Characterization Initiative (MDCI) in Oncology Clinical Trials

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04772053
• Other study ID #: 213299
• Status: Terminated
• Phase: Phase 2
• Start date: May 25, 2021
• Est. completion date: November 15, 2022

Study information

• Verified date: November 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single arm interventional molecular analysis study with no administration of investigational product and no masking. This multicenter study will involve participants with advanced/metastatic disease for the purpose of collecting tumor tissue and blood samples for broad molecular analysis and examining the expression of specific biomarkers using validated clinical assays.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant is a candidate for molecular screening for a GlaxoSmithKline (GSK) precision therapeutic clinical study (the Intended Treatment Protocol) that is being conducted in parallel at or nearby the MDCI recruitment site.

• Participant is willing to travel to a site recruiting for the intended GSK treatment protocol (or alternative treatment protocol), if feasible, and if, in the investigator's opinion, the participant would benefit from enrolment into the intended GSK treatment protocol at an alternative clinical site.

• Participants with confirmed advanced/metastatic diagnosis of solid malignancy in one of the following disease-areas: Non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), Breast, ovarian, and colorectal cancer (CRC).

• Participants with life expectancy of greater than (>) 6 months.

• Participants who are able to provide blood samples.

• Participants who are able to provide an archival formalin-fixed paraffin-embedded (FFPE) tumor specimen from a current lesion/most current setting (from no more than 2 years ago). If an archival tumor specimen is not available, surplus tissue from standard of care procedures is acceptable before fresh biopsy may be obtained.

• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

• Female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) or Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of less than [<]1 percent [%] per year), preferably with low user dependency; A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) as required by local regulations) within 24 hours before tumor biopsy; and if a urine test cannot be confirmed as negative (for example, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.

• The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

• Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).

Exclusion Criteria:

• Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status >2.

• Participants with history of myocardial infarction, acute inflammatory heart disease, unstable angina, or uncontrolled arrhythmia within the past 6 months.

• For female participants, pregnancy.

• Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with the participant's safety, obtaining informed consent or compliance to the screening study procedures.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Non-Small Cell
• Neoplasms

Intervention

Procedure:
• Tumor biopsy
Archived or fresh tumor biopsy samples will be collected.

Locations

Country	Name	City	State
Spain	GSK Investigational Site	Madrid
United States	GSK Investigational Site	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Positive Inducible T-cell Co-Stimulator (ICOS) Status	Blood samples were collected for clinical biomarker testing and a tumor specimen was collected as per tumor specimen collection requirements. The specimen was evaluated by immunohistochemistry (IHC) to determine the expression of tumor specific antigens and immune markers. The ICOS is the biomarkers and data for participants with its positive status has been presented.	Up to approximately 17 months
Primary	Number of Participants With Positive New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1)/Cancer Testis Antigen 2 (LAGE-1a) Status	Blood samples were collected for clinical biomarker testing and a tumor specimen was collected as per tumor specimen collection requirements. The specimen was evaluated by immunohistochemistry (IHC) to determine the expression of tumor specific antigens and immune markers. The NY-ESO-1 and LAGE-1a are biomarker and data for number of participants with its positive status has been presented.	Up to approximately 17 months
Primary	Number of Participants With Positive Programmed Death Protein 1 Ligand (PD-L1) Status	Blood samples were collected for clinical biomarker testing and a tumor specimen was collected as per tumor specimen collection requirements. The specimen was evaluated by immunohistochemistry (IHC) to determine the expression of tumor specific antigens and immune markers. The PD-L1 is a biomarker and data for number of participants with its positive status has been presented.	Up to approximately 17 months