Correlating Early FDG PET/CT and ctDNA in Immune Checkpoint Inhibitor (ICI)-Treated Melanoma Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-30

Study Completion Date

2029-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this research study is to determine if analysis of PET/CT scans and testing of blood samples in people with melanoma that has spread in their body can help researchers determine which patients are more or less likely to respond to immunotherapy and are more or less likely to have side effects. 24 participants will be enrolled and be on study until approximately 4 weeks after their first dose of Immune Checkpoint Inhibitor therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PET Quantitative Assessments of Solid Tumor Response to Immune Checkpoint Blockade Therapy

NCT01666353

Melanoma Renal Cell Carcinoma (RCC) Non-small Cell Lung Cancer (NSCLC)

COMPLETED EARLY_PHASE1

18F-FLT PET Imaging in Patients With Advanced Melanoma

NCT02891616

Melanoma

TERMINATED PHASE1

Early FDG PET in Melanoma

NCT02716077

Clinical Stage III Nodal or Intransit Disease or Resectable Stage IV Melanoma

TERMINATED NA

FDG-PET in Advanced Melanoma

NCT02236546

Recurrent Melanoma Stage IIIA Melanoma Stage IIIB Melanoma +2 more

TERMINATED NA

Interim FDG PET-CT in Melanoma Metastatic Patient's Treated by Anti-PD1 Therapy

NCT03888950

Metastatic Melanoma

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a pilot, prospective, observational study to estimate the degree to which baseline and early interval 18F-FDG PET/CT imaging within 3-4 weeks of ICI therapy initiation can accurately correlate with ctDNA level trends, predict clinical response, onset of immune-related adverse events, and survival outcomes in advanced stage melanoma patients.

Primary Objective

• To determine if early interval response assessment with 18F-FDG PET/CT during initial treatment with ICI therapy at 3-4 weeks correlates with ctDNA level changes in advanced melanoma patients.

Secondary Objectives

* To determine if early interval response assessment with 18F-FDG PET/CT during initial treatment with ICI therapy at 3-4 weeks predicts clinical efficacy at standard disease assessment time points in advanced melanoma patients.
* To assess if early interval response assessment with 18F-FDG PET/CT predicts development of clinical irAEs in advanced melanoma patients.
* To assess if early interval response assessment with 18F-FDG PET/CT and ctDNA level predicts progression-free survival (PFS) in advanced melanoma patients.
* To assess if early interval response assessment with 18F-FDG PET/CT and ctDNA level predicts overall survival (OS) in advanced melanoma patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Melanoma Melanoma Stage III Melanoma Stage IV Unresectable Melanoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Advanced Melanoma Patients with Immune Checkpoint Inhibitors

18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography

Intervention Type DIAGNOSTIC_TEST

research scan 3-4 weeks after start of immunotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography

research scan 3-4 weeks after start of immunotherapy

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

18F-FDG PET/CT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Willing to provide informed consent.
* Must have an advanced stage III or stage IV melanoma diagnosis for which treatment with ipilimumab, nivolumab, and/or pembrolizumab, either alone or in combination with other ICI therapy, is planned.
* Must be planning to participate in Signatera™ (ctDNA level) monitoring with standard of care laboratory testing routinely obtained for treatment with ICI therapy.
* Individuals at least 18 years of age.
* Women of childbearing potential must be willing to use effective contraception as discussed with their oncologist while participating in this study.
* Willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria

* Not able to receive treatment with ICI therapy
* Use of investigational drugs, biologics, or devices within 30 days prior to enrollment.
* Women who are pregnant, lactating, or planning on becoming pregnant during the study.
* Not suitable for study participation due to other reasons at the discretion of the investigators.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No