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CompletedNCT03356470Updated Jan 28, 2026

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

An observational study in Melanoma, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by University of Wisconsin, Madison · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 2,048 studies in Melanoma with a site in United States — 243 open to participants now, 439 under way, 32 of them phase 3. Melanoma · United States.

Enrollment
199th of 212
5 · median 156
Started
2017
with 84 others
Observational
212 of 2,048
47 open now
Registered
1,333rd of 2,048
by date

Among the 2,048 studies in Melanoma with a site in United States, this one is the 199th largest by enrollment of the 212 observational ones that give a count, is one of 85 that started in 2017, is one of 212 observational ones, and was the 1,333rd registered.

Melanoma

3,372 studies on the registry are indexed under Melanoma; 580 are open to participants now.

Browse Melanoma studies →

Open to participants now

243 of the 2,048 studies in Melanoma with a site in United States are open now. Recruiting first, the newest first:

238 more — sign in →

All 243 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 468 Melanoma studies recruiting now, 381 (81%) set no upper age limit and 49 (10%) stop at 75 or younger; 47 take children under 18; 29 take healthy volunteers.

This study: 18 Years and older · all sexes.

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02

Study 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.

03

Conditions studied

  • Melanoma

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Keywords

  • melanoma
  • antimelanoma T cells
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants must have a 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
  • Women of must be willing to use effective as discussed with their oncologist while participating in this study.

Exclusion criteria

Exclusion Criteria:

  • Not able to receive treatment with either nivolumab or pembrolizumab.
  • Women of 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherF-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.

    Also known as: 3'-Deoxy-3'-[18F]Fluorothymidine (FLT) PET/CT

This study also gives Pembrolizumab, Nivolumab. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. Correlation of baseline of response and antitumor response

    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

    Time frame: Anticipated at one-year after last patient enrolled, around Sept 2019

Secondary outcomes

  1. Correlation of in vivo clonally amplified T cells to FDG PET uptake in melanoma tumors

    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

    Time frame: Anticipated at one-year after last patient enrolled, around Sept 2019

  2. To correlate histologic and molecular markers of antitumor response to FLT PET uptake in melanoma tumors following treatment with anti-PD-1

    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

07

Study locations

1 site
  • University of Wisconsin Carbone Cancer Center
    Madison, Wisconsin 53792, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in Jun 2022, 55 months.

Of 177 non-industry observational studies under Melanoma, half reached primary completion within 178 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 320. This study's 55 months is below that.

Counting every sponsor, half of 236 studies reached it within 71 months; a quarter within 35 and three quarters within 248.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 22, 2017
First posted
Nov 29, 2017
StartActual
Nov 2, 2017
Primary completionActual
Jun 17, 2022
CompletionActual
Jun 17, 2022
Last update
Jan 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03356470
Responsible party
Sponsor
First posted
Nov 29, 2017
Start date
Nov 2, 2017
Primary completion
Jun 17, 2022
Completion
Jun 17, 2022
Last update
Jan 28, 2026

Study contacts

Mark Albertini
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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