Status:
RECRUITING
Evaluation of Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Clinical Stage III Cutaneous Melanoma AJCC v8
Clinical Stage IV Cutaneous Melanoma AJCC v8
Eligibility:
All Genders
18+ years
Brief Summary
This study explores the role of T cells in monitoring disease status and response during anti-PD-1/PD-L1 treatment in patients with melanoma, lung and other cancer types. Measuring levels of specific ...
Detailed Description
PRIMARY OBJECTIVES: I. Establish the role of Bim for monitoring disease status during anti-PD-1 therapy. II. Identify the mechanisms of resistance to anti-PD-1 blockade. III. Quantify and modulate l...
Eligibility Criteria
Inclusion
- Are 18 years of age or older
- Have histologic evidence of locally or regionally advanced or stage IV malignancy
- Are considered appropriate for starting therapy with anti-PD-1/anti-PD-L1 monoclonal antibody by their treating physician (prior therapy with immune checkpoint inhibitor (ICI) is allowed)
- Have an understanding of the protocol and its requirements, risks, and discomforts
- Are willing to undergo peripheral blood collection at the time points mentioned in the protocol
- Are able and willing to sign an informed consent
Exclusion
- Inability on the part of the patient to understand the informed consent or be compliant with the protocol
- Patients receiving any concurrent anti-cancer therapy or investigational agents (with the exception of an anti-PD-1/anti-PD-L1 agent as mentioned above)
- Patients who are pregnant, nursing, or are of childbearing potential and are unwilling to employ adequate contraception
Key Trial Info
Start Date :
June 15 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06075524
Start Date
June 15 2015
End Date
December 31 2026
Last Update
December 26 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905