Personalizing Immune Checkpoint Inhibitor Therapy

NCT03409341 | Withdrawn

• 1 other identifier: IRB# 2018-02
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, observational study will evaluate whether vitro testing of tumor tissue and white blood cells from patients with lung cancer who are being treated with immune checkpoint inhibitors and other standard of care approaches, predicts clinical response to these agents.

Conditions

Lung Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

• Anti-tumor immune response

  Tumor antigen presentation and anti-tumor T-cell response

  12 months

Secondary Outcomes (2)

• Clinical response

  12 months for each subject

• Tumor microenvironment

  24 months total study duration

Interventions

Blood and tumor tissue analysis, Clinical response. OTHER

DNA sequencing and functional testing of peripheral blood mononuclear cells. DNA and RNA sequencing and immune cell analysis of tumor. Clinical response at 12 months.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

• Ten subjects with lung cancer about to undergo diagnostic/excisional biopsy with the intent to receive therapy with immune checkpoint inhibitors

You may qualify if:

• Subjects with lung cancer about to undergo diagnostic/excisional biopsy with the intent to receive therapy with immune checkpoint inhibitors
• Availability of fresh tumor tissue removed at excisional biopsy or diagnostic biopsy
• Informed consent

You may not qualify if:

• Lack of informed consent

Sponsors & Collaborators

• Holy Cross Hospital, Maryland: lead

Study Sites (1)

Holy Cross Hospital

Silver Spring, Maryland, 20910, United States

Location

Related Publications (6)

• Sindhi R, Ashokkumar C, Higgs BW. Cellular alloresponses for rejection-risk assessment after pediatric transplantation. Curr Opin Organ Transplant. 2011 Oct;16(5):515-21. doi: 10.1097/MOT.0b013e32834a94e3.

  PMID: 21844808 BACKGROUND

• Ashokkumar C, Talukdar A, Sun Q, Higgs BW, Janosky J, Wilson P, Mazariegos G, Jaffe R, Demetris A, Dobberstein J, Soltys K, Bond G, Thomson AW, Zeevi A, Sindhi R. Allospecific CD154+ T cells associate with rejection risk after pediatric liver transplantation. Am J Transplant. 2009 Jan;9(1):179-91. doi: 10.1111/j.1600-6143.2008.02459.x. Epub 2008 Oct 31.

  PMID: 18976293 BACKGROUND

• Ningappa M, Ashokkumar C, Higgs BW, Sun Q, Jaffe R, Mazariegos G, Li D, Weeks DE, Subramaniam S, Ferrell R, Hakonarson H, Sindhi R. Enhanced B Cell Alloantigen Presentation and Its Epigenetic Dysregulation in Liver Transplant Rejection. Am J Transplant. 2016 Feb;16(2):497-508. doi: 10.1111/ajt.13509. Epub 2015 Dec 11.

  PMID: 26663361 BACKGROUND

• Ranganathan S, Ningappa M, Ashokkumar C, Higgs BW, Min J, Sun Q, Schmitt L, Subramaniam S, Hakonarson H, Sindhi R. Loss of EGFR-ASAP1 signaling in metastatic and unresectable hepatoblastoma. Sci Rep. 2016 Dec 2;6:38347. doi: 10.1038/srep38347.

  PMID: 27910913 BACKGROUND

• Vinayak R, Cruz RJ Jr, Ranganathan S, Mohanka R, Mazariegos G, Soltys K, Bond G, Tadros S, Humar A, Marsh JW, Selby RR, Reyes J, Sun Q, Haberman K, Sindhi R. Pediatric liver transplantation for hepatocellular cancer and rare liver malignancies: US multicenter and single-center experience (1981-2015). Liver Transpl. 2017 Dec;23(12):1577-1588. doi: 10.1002/lt.24847.

  PMID: 28834194 BACKGROUND

• Cruz RJ Jr, Ranganathan S, Mazariegos G, Soltys K, Nayyar N, Sun Q, Bond G, Shaw PH, Haberman K, Krishnamurti L, Marsh JW, Humar A, Sindhi R. Analysis of national and single-center incidence and survival after liver transplantation for hepatoblastoma: new trends and future opportunities. Surgery. 2013 Feb;153(2):150-9. doi: 10.1016/j.surg.2012.11.006.

  PMID: 23331862 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

1. Peripheral blood samples will be used to evaluate immune cell anti-tumor response, and DNA sequence. 2. A sample of tumor tissue excised for diagnostic biopsy will be used to evaluate tumor immunogenicity, tumor transcriptome, tumor infiltrating immune cells, and tumor DNA sequence.

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 24, 2018
• Study Start: February 1, 2019
• Primary Completion: January 8, 2020
• Study Completion: September 22, 2020
• Last Updated: September 24, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 24 months
• Access Criteria: Upon completion, published results will be provided to participants

Locations

US (1)