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Pilot Study of Biomarkers of Response to Immune Checkpoint Blockade in Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT03356470
Recruitment Status : Enrolling by invitation
First Posted : November 29, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study uses molecular imaging and novel immune monitoring to identify a biomarker of response for melanoma patients receiving immunotherapy with anti-PD-1 immunotherapy. Prior to treatment, FDG and FLT PET/CT will be obtained, together with blood and tumor biopsies from each patient. A follow-up FDG and FLT PET/CT will be obtained, together with blood and tumor biopsies, 10-12 weeks after starting treatment with anti-PD-1 antibody. Additional tumor biopsies and blood samples for immune monitoring will be obtained 4-6 weeks after starting treatment with anti-PD-1 antibody as well as 16-18 weeks after starting anti-PD-1 treatment for patients still receiving anti-PD-1 antibody at that time.

Condition or disease Intervention/treatment
Melanoma Other: F-FDG PET/CT

Study Design

Study Type : Observational
Estimated Enrollment : 4 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of Biomarkers of Response to Immune Checkpoint Blockade in Metastatic Melanoma
Actual Study Start Date : November 2, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
FLT/PET + biopsy
F-FDG and FLT PET/CT imaging will be obtained prior to anti-cancer treatment and 10-12 weeks after starting treatment with anti-PD-1 antibody.
Other: F-FDG PET/CT
F-FLT PET uses a thymidine analogue that accumulates in proliferating tissue. Proliferating tissue could include malignant lesions or immune cells. In this study, FLT PET/CT will be utilized as a molecular imaging tool to detect immune activation after administration of immune checkpoint blockade with pembrolizumab or nivolumab.
Other Name: 3'-Deoxy-3'-[18F]Fluorothymidine (FLT) PET/CT


Outcome Measures

Primary Outcome Measures :
  1. Correlation of baseline of response and antitumor response [ Time Frame: Anticipated at one-year after last patient enrolled, around Sept 2019 ]
    To correlate baseline and post-treatment molecular imaging biomarkers of response to immunotherapy with anti-PD-1 with antitumor response based on analysis of the FDG-to-FLT PET/CT ratio in melanoma patients


Secondary Outcome Measures :
  1. Correlation of in vivo clonally amplified T cells to FDG PET uptake in melanoma tumors [ Time Frame: Anticipated at one-year after last patient enrolled, around Sept 2019 ]
    To correlate in vivo clonally amplified T cells in blood that traffic to tumor to FDG PET uptake in melanoma tumors following treatment with anti-PD-1

  2. To correlate histologic and molecular markers of antitumor response to FLT PET uptake in melanoma tumors following treatment with anti-PD-1 [ Time Frame: Anticipated at one-year after last patient enrolled, around Sept 2019 ]
    To correlate histologic and molecular markers of antitumor response to FLT PET uptake in melanoma tumors following treatment with anti-PD-1


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Up to 4 metastatic melanoma patients will be recruited from the University of Wisconsin (UW) Carbone Cancer Center (CCC) Melanoma Clinic located in the UW-Hospital and Clinics.
Criteria

Inclusion Criteria:

  • Participants must have a metastatic melanoma diagnosis (stage IV) for which treatment with nivolumab or pembrolizumab, either alone or in combination with other therapies, is planned. No additional laboratory testing is needed for the imaging in this study apart from the standard laboratory testing routinely obtained for treatment with nivolumab or pembrolizumab, either alone or in combination with other therapies.
  • Participants must have at least 2 subcutaneous or lymph node melanoma metastases that are 2 cm in greatest diameter and are amenable to being biopsied in clinic without requiring image-guidance.
  • Participants must be able to provide informed consent
  • Women of childbearing potential must be willing to use effective contraception as discussed with their oncologist while participating in this study.

Exclusion Criteria:

  • Not able to receive treatment with either nivolumab or pembrolizumab.
  • Women of child-bearing potential must have a negative serum or urine pregnancy test within 7 days of the first study FDG and FLT PET/CT and must not be breast feeding for the duration of study participation.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356470


Locations
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mark Albertini University of Wisconsin, Madison
More Information

Additional Information:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03356470     History of Changes
Other Study ID Numbers: UW16032
2017-0046 ( Other Identifier: Institutional Review Board )
P30CA014520 ( U.S. NIH Grant/Contract )
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Wisconsin, Madison:
melanoma
antimelanoma T cells

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas