COMPLETED

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

Conditions

Melanoma Advanced Melanoma Peripheral T Cell Pembrolizumab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-29

Study Completion:2025-09-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05105100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. Must have one or more sites of disease amenable to biopsy (tumor, skin, lymph node, pleural fluid, peritoneal fluid, cerebral spinal fluid (CSF)). 3. 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. 4. Participants must be age 18 years or older on the day of signing informed consent. 5. Have the ability to provide written informed consent for the trial. 6. Be able and willing to comply with study procedures including provision of basic demographic information and medical history. 7. Be willing to receive periodic follow up phone calls to monitor health status and survival status.	1. 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)). 2. Has received prior systemic anti-cancer therapy including investigational agents within the prior 2 weeks. 3. 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. 4. Has a contraindication to tissue biopsy for minimally-invasive research-procedure 5. Contraindication to phlebotomy (up to 20 milliliters (mL)) per phlebotomy every three weeks).

Inclusion Criteria

Exclusion Criteria

1. 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.
2. Must have one or more sites of disease amenable to biopsy (tumor, skin, lymph node, pleural fluid, peritoneal fluid, cerebral spinal fluid (CSF)).
3. 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.
4. Participants must be age 18 years or older on the day of signing informed consent.
5. Have the ability to provide written informed consent for the trial.
6. Be able and willing to comply with study procedures including provision of basic demographic information and medical history.
7. Be willing to receive periodic follow up phone calls to monitor health status and survival status.

1. 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)).
2. Has received prior systemic anti-cancer therapy including investigational agents within the prior 2 weeks.
3. 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.
4. Has a contraindication to tissue biopsy for minimally-invasive research-procedure
5. Contraindication to phlebotomy (up to 20 milliliters (mL)) per phlebotomy every three weeks).

Contacts and Locations

Principal Investigator

Adil Daud, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Adil Daud, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-29

Study Completion Date2025-09-15

Study Record Updates

Study Start Date2021-10-29

Study Completion Date2025-09-15

Terms related to this study

Keywords Provided by Researchers

Peripheral T Cell
Pembrolizumab

Additional Relevant MeSH Terms

Melanoma
Advanced Melanoma