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

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Oct 25, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how certain immune cells in the body, called T cells, can help predict how well patients with advanced melanoma will respond to a treatment called pembrolizumab. The researchers believe that by analyzing these T cells, they can better understand why some patients benefit from this immunotherapy while others do not. The goal is to identify specific characteristics of these T cells that may indicate whether a patient will respond positively to the treatment.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of locally advanced or metastatic melanoma, starting treatment with pembrolizumab. They should have areas of their disease that can be biopsied, meaning a small sample can be taken for study. Participants will provide some basic information about their health and will be monitored over time through phone calls to check on their well-being. It's important to note that those who have previously received certain other immunotherapy treatments or have specific medical conditions may not qualify for this study.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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).