NCT05105100Completed
Peripheral T Cell Determinants of Response and Resistance to Pembrolizumab in Melanoma
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 25 (actual)
- First submitted
- 12 Oct 2021
- Start date
- 29 Oct 2021
- Primary completion date
- 15 Sept 2025
- Lead sponsor
- University of California, San Francisco
- Diseases
- Melanoma
- NCT number
- NCT05105100
What you commit to
- Study type: Observational
- Participants enrolled: 25
- From 29 Oct 2021 to the primary completion date, 15 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Lab values
- 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)).
Other
- Has a contraindication to tissue biopsy for minimally invasive research-procedure.
- Contraindication to phlebotomy (up to 40 milliliters (mL)) per phlebotomy every three weeks).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.