Lung Cancer Stage IVNCT03409341
Personalizing Immune Checkpoint Inhibitor Therapy
An observational study of Lung Cancer Stage IV, run by Holy Cross Hospital, Maryland at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Cancer Stage IV
- What is being tested?
- Blood and tumor tissue analysis, Clinical response.
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 22 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: • Ten subjects with lung cancer about to undergo diagnostic/excisional biopsy with the intent to receive therapy with immune checkpoint inhibitors
Who may be able to join
- 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
Who cannot join
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalizing Immune Checkpoint Inhibitor Therapy for Solid Tumors
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.
Read the detailed description
Overall Goal: The long-term goal of this study is to predict whether checkpoint inhibitors will be effective in individual patients with solid tumors.
Objectives: In this pilot study to be conducted in ten subjects with lung cancer who are to receive checkpoint inhibitors, we will use cellular and molecular techniques to characterize
- tumor immunogenicity
- anti-tumor T-cell response
- effect of checkpoint inhibitors on antigen presentation and T-cell response, and
- the tumor microenvironment
Planned enrollment:
- Ten subjects with lung cancer
Methods for Informed Consent:
Investigators will approach subjects for informed consent
- Conditions
- Lung Cancer Stage IV
- Being tested
- Blood and tumor tissue analysis, Clinical response.
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-tumor immune response
Tumor antigen presentation and anti-tumor T-cell response
Measured: 12 months
Secondary outcomes (2)
Clinical response
Clinical response is defined as 50% or greater decrease of the sum of the products of two-dimensional measurements of lesions on imaging within the first year.
Measured: 12 months for each subject
Tumor microenvironment
Tumor mutation burden from tumor genome landscape using DNA sequencing, tumor transcriptome with RNA sequencing, tumor infiltrating immune cells with flow cytometry
Measured: 24 months total study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start1 Feb 2019
- Primary completion8 Jan 2020
- Study completion22 Sep 2020
Why it stopped: No enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holy Cross Hospital, Maryland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409341
- Sponsor's protocol ID
- IRB# 2018-02
- Status last verified
- Sep 2020
- First submitted
- 18 Jan 2018
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing: The data generated in this study will be available to The Holy Cross Health Institutional Review Board, Inc., Investigators named in this protocol, and Officials of the FDA and HHS. Published information following completion of the study will be provided to study patients.
Publications
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.
PubMed 21844808Ashokkumar 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.
PubMed 18976293Ningappa 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.
PubMed 26663361Ranganathan 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.
PubMed 27910913Vinayak 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.
PubMed 28834194Cruz 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.
PubMed 23331862
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalizing Immune Checkpoint Inhibitor Therapy for Solid Tumors
- ClinicalTrials.gov ID
- NCT03409341
- Acronym / sponsor ID
- IRB# 2018-02
- Conditions
- Lung Cancer Stage IV
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Holy Cross Hospital, MarylandUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Overall Goal: The long-term goal of this study is to predict whether checkpoint inhibitors will be effective in individual patients with solid tumors.
Objectives: In this pilot study to be conducted in ten subjects with lung cancer who are to receive checkpoint inhibitors, we will use cellular and molecular techniques to characterize
- tumor immunogenicity
- anti-tumor T-cell response
- effect of checkpoint inhibitors on antigen presentation and T-cell response, and
- the tumor microenvironment
Planned enrollment:
- Ten subjects with lung cancer
Methods for Informed Consent:
Investigators will approach subjects for informed consent
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- • Ten subjects with lung cancer about to undergo diagnostic/excisional biopsy with the intent to receive therapy with immune checkpoint inhibitors
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and tumor tissue analysis, Clinical response.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. | Other | – |
Primary outcome
Anti-tumor immune response
Time frame: 12 months
Tumor antigen presentation and anti-tumor T-cell response
2 secondary outcomes
Clinical response
Time frame: 12 months for each subject
Tumor microenvironment
Time frame: 24 months total study duration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Background: PubMed 21844808Sindhi 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.
- Background: PubMed 18976293Ashokkumar 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.
- Background: PubMed 26663361Ningappa 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.
- Background: PubMed 27910913Ranganathan 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.
- Background: PubMed 28834194Vinayak 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.
- Background: PubMed 23331862Cruz 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.
- Individual participant dataSharing planned: Yes. Data sharing: The data generated in this study will be available to The Holy Cross Health Institutional Review Board, Inc., Investigators named in this protocol, and Officials of the FDA and HHS. Published information following completion of the study will be provided to study patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer Stage IV, run by Holy Cross Hospital, Maryland at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-tumor immune response (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03409341, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.