MRI and PET to Assess Pembrolizumab Response

A Feasibility Study of MRI and PET Imaging to Assess Response to MK-3475 (Pembrolizumab) in Patients With Metastatic Melanoma

NCT02591654•Columbia University

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Summary

The purpose of this study is to test two imaging techniques, one called whole body (WB) diffusion weighted (DWI) magnetic resonance imaging (MRI) (WB-DWI MRI), and another called Fluorine-18 3'-deoxy-3'-fluorothymidine positron emission tomography (PET) (F-18-FLT PET). The goal is to see whether these imaging techniques would allow the study doctors to see changes in the size of a tumor earlier for patients with metastatic melanoma receiving Pembrolizumab (MK-3475).

Detailed Description

There is a growing body of evidence that demonstrates that tumor proliferation, measured classically by immunohistochemical evidence of increased Ki-67 expression, can be reliably determined in vivo using radiolabeled thymidine. The development of \[18F\]-fluorothymidine (FLT) PET has been reliably identified as a marker of cellular proliferation, and has been shown to identify changes in proliferation in successfully treated patients.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed diagnosis of melanoma
•Stage III or stage IV metastatic melanoma
•Disease that is measurable. This is defined as lesions measuring at least 10mm on radiologic imaging. For lymph node disease, the lesion must measure at least 15 mm or have been biopsied and shown to contain melanoma. Skin or mucosal lesions that are not measurable on radiologic imaging but measure at least 10mm on clinical exam are also acceptable. (See Section 13.2 for detailed definition of measurable disease)
•Disease is termed unresectable or the patient refuses resection
•The Eastern Cooperative Oncology Group (ECOG) performance status of 1 or better
•Age ≥18 years. This is due to the limited data with pembrolizumab in children younger than 18 years of age.
•Normal organ and marrow function as defined below
•* Aspartate aminotransferase (AST) (SGOT) or alanine aminotransferase (ALT) (SGPT) ≤2.5 × institutional upper limit of normal (≤5 x upper limit of normal for patient with liver metastasis)
•* Total bilirubin within 1.5 x institutional level of normal or direct bilirubin ≤ upper limit of normal (ULN) for patient with total bilirubin levels \> 1.5 ULN)
•* Hemoglobin ≥ 9.0g/dL or ≥5.6mmol/L
+4 more criteria

Exclusion Criteria

•Prior therapy with anti-PD-1 antibody
•The patient has symptomatic brain metastases. Asymptomatic brain metastases are permitted provided that there is no steroid requirement, no more than 4 metastases detected on standard MRI imaging, no metastatic brain lesion that is \> 3 cm in size, and no lepto-meningeal disease.
•Patient has not recovered to Grade 0-1 from adverse events due to prior chemotherapy, radiation, or biological cancer therapy (including monoclonal antibody (mAb)).
•The patient is not recovered from minor or major surgery and is less than 4 weeks from major surgery prior to starting treatment with pembrolizumab
•Significant auto-immune disease requiring hospitalization within the past two years or any history of life-threatening auto-immune disease
•Immunosuppressive therapy including systemic corticosteroids except for maintenance dosing for adrenal insufficiency
•Concurrent use of any other investigational agents
•Active central nervous system metastasis and/or carcinomatous meningitis causing symptoms.
•Known additional malignancy that is progressing or requires active treatment with the exceptions of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
•Active autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents with the exceptions of replacement dose steroids for adrenal insufficiency, vitiligo, resolved childhood asthma/atopy, intermittent use of inhaled steroids, local steroid injections, hypothyroidism stable on hormone replacement, and Sjogren's syndrome
+11 more criteria

Locations (1)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, United States

Key Dates

Start Date

October 1, 2015

Primary Completion Date

October 1, 2022

Completion Date

October 1, 2022

Last Updated

December 30, 2022

Enrollment

ACTUAL participants

Conditions

Malignant Melanoma, Metastatic

Interventions

Pembrolizumab

DRUG

FLT PET

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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