Analysis of Biopsy Specimens to Study Responses to PD-1 or PD-L1 Therapies
NCT ID: NCT03877250
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2019-03-08
2020-08-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Non Small Cell Lung Cancer (NSCLC)
Participants with pathologically confirmed newly diagnosed or recurrent advanced NSCLC that is PD-L1 high by immunohistochemistry
Pre-Treatment Biopsy
Participants screened for participation will include those with a diagnosis of advanced NSCLC who have undergone a pre-treatment biopsy prior to start of therapy with a PD-(L)1 inhibitor or who are medically able to undergo a biopsy if (1) no pre-treatment biopsy has been obtained and (2) no PD-(L)1 inhibitor has been started.
On-Treatment Biopsy
All participants who receive at least 1 dose of PD-(L)1 inhibitor will be referred for a biopsy. The biopsy should be obtained within 4 weeks of first on-treatment imaging (usually performed \~6-9 weeks after beginning therapy) and will be performed in participants regardless of radiologic response.
Biopsy at Disease Progression
All participants who develop disease progression after initial response to PD-(L)1 blockade will be considered for an additional, optional biopsy. Biopsies at disease progression are often obtained per standard of care within 4 weeks of documented progression on imaging and prior to the initiation of further systemic therapy.
Peripheral Blood-Based Studies
All participants will have peripheral blood obtained on Day 1 of cycles 1-4 (0, 3, 6, and 9 weeks). At each time point, peripheral blood sample will be collected pre-treatment and used for analysis of T cell subsets and TCR sequencing.
Interventions
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Pre-Treatment Biopsy
Participants screened for participation will include those with a diagnosis of advanced NSCLC who have undergone a pre-treatment biopsy prior to start of therapy with a PD-(L)1 inhibitor or who are medically able to undergo a biopsy if (1) no pre-treatment biopsy has been obtained and (2) no PD-(L)1 inhibitor has been started.
On-Treatment Biopsy
All participants who receive at least 1 dose of PD-(L)1 inhibitor will be referred for a biopsy. The biopsy should be obtained within 4 weeks of first on-treatment imaging (usually performed \~6-9 weeks after beginning therapy) and will be performed in participants regardless of radiologic response.
Biopsy at Disease Progression
All participants who develop disease progression after initial response to PD-(L)1 blockade will be considered for an additional, optional biopsy. Biopsies at disease progression are often obtained per standard of care within 4 weeks of documented progression on imaging and prior to the initiation of further systemic therapy.
Peripheral Blood-Based Studies
All participants will have peripheral blood obtained on Day 1 of cycles 1-4 (0, 3, 6, and 9 weeks). At each time point, peripheral blood sample will be collected pre-treatment and used for analysis of T cell subsets and TCR sequencing.
Eligibility Criteria
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Inclusion Criteria
* Intended treatment with a PD-(L)1 inhibitor
* Age \>/= 18 years
* Karnofsky Performance Status \>/= 70% and medically fit to undergo a biopsy procedure
Exclusion Criteria
* Pregnant or breastfeeding women
* Cognitively impairment affecting ability to understand and provide informed consent
* Prior PD-(L)1 blockade treatment
* Chemotherapy within 6 months prior to enrollment
18 Years
ALL
No
Sponsors
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Wang Initiative in Lung Cancer Clinical Trials
UNKNOWN
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Matthew Hellmann, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memoral Sloan Kettering Basking Ridge (Consent and Follow up)
Basking Ridge, New Jersey, United States
Memoral Sloan Kettering Monmouth (Consent and Follow up)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent and Follow up)
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk (Consent Only)
Commack, New York, United States
Memoral Sloan Kettering Westchester (Consent & Follow Up)
Harrison, New York, United States
Memorial Sloan - Kettering Cancer Center (Consent and follow-up)
New York, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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19-030
Identifier Type: -
Identifier Source: org_study_id
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