Evaluation of Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types
Part of paid clinical trials in Rochester, Minnesota.
- Sponsor
- Mayo Clinic
- Study ID
- NCT06075524
- Status
- Recruiting
Conditions
- Clinical Stage III Cutaneous Melanoma AJCC v8
- Clinical Stage IV Cutaneous Melanoma AJCC v8
- Locally Advanced Lung Carcinoma
- Locally Advanced Malignant Solid Neoplasm
- Locally Advanced Melanoma
- Metastatic Lung Carcinoma
- Metastatic Malignant Solid Neoplasm
- Metastatic Melanoma
- Stage III Lung Cancer AJCC v8
- Stage IV Lung Cancer AJCC v8
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biospecimen Collection — PROCEDUREUndergo blood and optional stool/tissue sample collection
- Electronic Health Record Review — OTHERMedical records are reviewed
Study Details
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 targets such as Bim and soluble PD-L1 during therapy may help track treatment resistance and clinical outcomes. This information may also help researchers determine why some people with melanoma, lung and other cancer types respond to PD-1/PD-L1 treatment and others do not.
Key Dates
- Start date
- Jun 15, 2015
- Status verified
- Dec 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 500 participants (estimated)
Arms
- Arm: Observational (Blood and stool sample collection)Patients undergo blood sample collection throughout the study. Patients also undergo optional stool sample collection and have their medical records reviewed on study. In addition, patients provide previously-collected tissue sample, if available.
Primary Outcome Measure
Role of Bim for monitoring disease status during anti-PD-1 therapy [ Time Frame: Up to 10 samples: at baseline; 6 weeks after initiation of therapy; subsequently at each radiographic tumor assessment (starting at approx. 9-12 weeks) including at confirmed disease progression. ]
Central Contacts
- Clinical Trials Referral Office855-776-0015
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | Svetomir N. Markovic, MD, PhD (PRINCIPAL_INVESTIGATOR) |
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