Trials / Completed
CompletedNCT05105100
Peripheral T Cell Determinants of Response and Resistance to Pembrolizumab in Melanoma
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 25 (actual)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 Programmed death-1 (PD-1) therapy.
Detailed 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. Outline: Participants will have blood drawn and tumor biopsied. Participants will be followed for 6 months from time of treatment initiation. After 6 months, participants do not need to be followed but standard of care scans and survival status can be assessed for up to 5 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Biopsy | Tumor tissue collection |
| PROCEDURE | Biospecimen Collection | Intravenously Blood draw |
Timeline
- Start date
- 2021-10-29
- Primary completion
- 2025-09-15
- Completion
- 2025-09-15
- First posted
- 2021-11-03
- Last updated
- 2026-04-06
- Results posted
- 2026-04-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05105100. Inclusion in this directory is not an endorsement.