Trial Outcomes & Findings for Molecular Disease Characterization Initiative (MDCI) (NCT NCT04772053)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Up to approximately 17 months

Results posted on

2024-04-19

Participant Flow

The study was terminated for reasons pertaining to feasibility.

Participant milestones

Participant milestones
Measure	Participants Who Underwent Tumor Biopsy Participants with advanced/metastatic diagnosis of malignancy disease underwent tumor biopsy.
Overall Study STARTED	6
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants Who Underwent Tumor Biopsy Participants with advanced/metastatic diagnosis of malignancy disease underwent tumor biopsy.
Overall Study Physician Decision	2
Overall Study Withdrawal by Subject	3
Overall Study Study Terminated by Sponsor	1

Baseline Characteristics

Molecular Disease Characterization Initiative (MDCI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Who Underwent Tumor Biopsy n=6 Participants Participants with advanced/metastatic diagnosis of malignancy disease underwent tumor biopsy.
Age, Continuous	58.2 YEARS STANDARD_DEVIATION 9.85 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized White	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 17 months

Population: Enrolled population included all participants who signed the informed consent form (ICF) and met inclusion criteria.

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.

Outcome measures

Outcome measures
Measure	Participants Who Underwent Tumor Biopsy n=6 Participants Participants with advanced/metastatic diagnosis of malignancy disease underwent tumor biopsy.
Number of Participants With Positive Inducible T-cell Co-Stimulator (ICOS) Status	2 Participants

PRIMARY outcome

Timeframe: Up to approximately 17 months

Population: Enrolled population

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.

Outcome measures

Outcome measures
Measure	Participants Who Underwent Tumor Biopsy n=6 Participants Participants with advanced/metastatic diagnosis of malignancy disease underwent tumor biopsy.
Number of Participants With Positive New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1)/Cancer Testis Antigen 2 (LAGE-1a) Status	1 Participants

PRIMARY outcome

Timeframe: Up to approximately 17 months

Population: Enrolled population

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.

Outcome measures

Outcome measures
Measure	Participants Who Underwent Tumor Biopsy n=6 Participants Participants with advanced/metastatic diagnosis of malignancy disease underwent tumor biopsy.
Number of Participants With Positive Programmed Death Protein 1 Ligand (PD-L1) Status	0 Participants

Adverse Events

Participants Who Underwent Tumor Biopsy

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Participants Who Underwent Tumor Biopsy n=6 participants at risk Participants with advanced/metastatic diagnosis of malignancy disease underwent tumor biopsy.
Gastrointestinal disorders Dysphagia	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 17 months. Enrolled population included all participants who signed the informed consent form (ICF) and met inclusion criteria

Other adverse events

Other adverse events
Measure	Participants Who Underwent Tumor Biopsy n=6 participants at risk Participants with advanced/metastatic diagnosis of malignancy disease underwent tumor biopsy.
General disorders Asthenia	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 17 months. Enrolled population included all participants who signed the informed consent form (ICF) and met inclusion criteria
General disorders Chest discomfort	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 17 months. Enrolled population included all participants who signed the informed consent form (ICF) and met inclusion criteria
General disorders Pyrexia	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 17 months. Enrolled population included all participants who signed the informed consent form (ICF) and met inclusion criteria
Infections and infestations COVID-19	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 17 months. Enrolled population included all participants who signed the informed consent form (ICF) and met inclusion criteria
Infections and infestations Ear infection	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 17 months. Enrolled population included all participants who signed the informed consent form (ICF) and met inclusion criteria
Musculoskeletal and connective tissue disorders Neck pain	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 17 months. Enrolled population included all participants who signed the informed consent form (ICF) and met inclusion criteria
Nervous system disorders Neuropathy peripheral	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 17 months. Enrolled population included all participants who signed the informed consent form (ICF) and met inclusion criteria
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 17 months. Enrolled population included all participants who signed the informed consent form (ICF) and met inclusion criteria

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER