Molecular Disease Characterization Initiative (MDCI)

NCT04772053 | Terminated Phase 2 Results

• 1 other identifier: 213299
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Lung Cancer, Non-Small Cell; Neoplasms

Keywords

Tumor biopsy; Molecular Disease Characterization Initiative; Oncology; Clinical trial

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Participants undergoing tumor biopsy

EXPERIMENTAL

Procedure: Tumor biopsy

Interventions

Tumor biopsy PROCEDURE

Archived or fresh tumor biopsy samples will be collected.

Participants undergoing tumor biopsy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Nashville, Tennessee, 37203, United States

Location

GSK Investigational Site

Madrid, 28050, Spain

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: May 25, 2021
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: April 19, 2024
• Results First Posted: April 19, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

US (1); ES (1)