Peripheral T Cell Determinants of Response and Resistance to Pembrolizumab in Melanoma

Completed

Conditions studied: Melanoma, Advanced Melanoma

In brief

This is a non-therapeutic study assessing peripheral T cell determinants of response and resistance to immunotherapy in patients with advanced melanoma.The hypothesis is that systemic T cells traffic into the tumor microenvironment (TME) can predict response and resistance to immunotherapy. These systemic tumor directed T cells can be defined by tumor/blood small conditional RNA (scRNA) using T cell receptor (TCR) as a barcode and can help predict response to Programmed death-1 (PD-1) therapy.

Key facts

Study ID

NCT05105100

Run by

University of California, San Francisco

People needed

25

Starts

2021-10-29

Expected to finish

2025-09-15

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have histologically confirmed locally advanced or metastatic melanoma and be starting on standard of care pembrolizumab monotherapy. Participants may have received any or no prior anti-cancer therapy without limitation.
• Must have one or more sites of disease amenable to biopsy (tumor, skin, lymph node, pleural fluid, peritoneal fluid, cerebral spinal fluid (CSF)).
• Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• Participants must be age 18 years or older on the day of signing informed consent.
• Have the ability to provide written informed consent for the trial.
• Be able and willing to comply with study procedures including provision of basic demographic information and medical history.
• Be willing to receive periodic follow up phone calls to monitor health status and survival status.

You may not qualify if…

• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX 40, Cluster of Differentiation 137 (CD137)).
• Has received prior systemic anti-cancer therapy including investigational agents within the prior 2 weeks.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
• Has a contraindication to tissue biopsy for minimally invasive research-procedure.
• Contraindication to phlebotomy (up to 40 milliliters (mL)) per phlebotomy every three weeks).

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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