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

  • STATUS
    Recruiting
  • End date
    Aug 28, 2026
  • participants needed
    25
  • sponsor
    University of California, San Francisco
Updated on 24 November 2021
metastatic melanoma
cancer
measurable disease
pembrolizumab
advanced melanoma

Summary

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 PD-1 therapy.

Description

Primary Objective:

To understand how the systemic immune profile (T cell activation and expansion in TME) changes in response to pembrolizumab therapy in patients with advanced melanoma on pembrolizumab monotherapy.

Exploratory Objectives :

I. To correlate the peripheral T cell profiles with the objective response rate (ORR) at 24 weeks in patients with advanced melanoma on pembrolizumab monotherapy.

II. To correlate the peripheral T cell profiles with progression free survival (PFS) in patients with advanced melanoma on pembrolizumab monotherapy.

III. To correlate the peripheral T cell profiles with overall survival (OS) in patients with advanced melanoma on pembrolizumab monotherapy.

IV. To correlate the peripheral T cell profiles with toxicity profile. V. Transcriptional and phenotypic features of tumor directed T cells in blood using a combination of phenotypic markers derived from COMET and cite-seq.

Patients will be followed for 6 months from time of treatment initiation. After 6 months, patients do not need to be followed but standard of care scans and survival status can be assessed for up to 5 years.

Details
Condition Malignant Melanoma, melanoma, Skin Cancer, Advanced Melanoma, Metastatic Melanoma, Melanoma, skin cancer
Treatment biopsy, biospecimen collection
Clinical Study IdentifierNCT05105100
SponsorUniversity of California, San Francisco
Last Modified on24 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must have histologically confirmed locally advanced or metastatic melanoma and be starting on standard of care pembrolizumab monotherapy. Patients 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

Exclusion Criteria

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 20 milliliters (mL)) per phlebotomy every three weeks)
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