Pilot Study of Biomarkers of Response to Immune Checkpoint Blockade in Metastatic Melanoma
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/16/2018 |
| Start Date: | November 2, 2017 |
| End Date: | July 2019 |
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.
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.
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 FLT PET/CT and must not be breast feeding for the
duration of study participation.
We found this trial at
1
site
600 Highland Ave.
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Mark Albertini
Phone: 800-622-8922
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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