500 Participants Needed

Evaluation of Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types

CT
Overseen ByClinical Trials Referral Office
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
Must be taking: Anti-PD-1/PD-L1
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This study explores the role of T cells in monitoring disease status and response during anti-PD-1/PD-L1 treatment in patients with melanoma, lung and other cancer types. Measuring levels of specific targets such as Bim and soluble PD-L1 during therapy may help track treatment resistance and clinical outcomes. This information may also help researchers determine why some people with melanoma, lung and other cancer types respond to PD-1/PD-L1 treatment and others do not.

Research Team

SN

Svetomir N. Markovic, MD, PhD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

Inclusion Criteria

You are capable and eager to sign a consent form.
Your healthcare provider deems you a suitable candidate for immunotherapeutic treatment with ICI-based anti-PD-1/anti-PD-L1 monoclonal antibodies.
You are aware of the protocol's stipulations, potential hazards and any discomfort it may cause.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial blood sample collection and baseline measurements for Bim levels and other markers

1 week
1 visit (in-person)

Monitoring

Ongoing blood sample collection and monitoring of T cell responses and resistance mechanisms during anti-PD-1 therapy

Up to 12 weeks
Up to 10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Participant Groups
1Treatment groups
Experimental Treatment
Group I: Observational (Blood and stool sample collection)Experimental Treatment2 Interventions
Patients undergo blood sample collection throughout the study. Patients also undergo optional stool sample collection and have their medical records reviewed on study. In addition, patients provide previously-collected tissue sample, if available.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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