A Study to Evaluate Maximizing Anti-PD-1 Therapy By Monitoring T Cell Responses In Melanoma, Lung and Other Cancer Types
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-000934
NCT ID: NCT06075524
Sponsor Protocol Number: MC200706
About this study
The purpose of this study is to monitor T cell responses from patients with advanced cancer who are being treated with an anti-PD (programmed death)-1 monoclonal antibody, and compare them with clinical outcomes.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Are 18 years of age or older.
- Have histologic evidence of locally or regionally advanced or stage IV malignancy.
- Are considered appropriate for starting therapy with anti-PD-1/anti-PD-L1 monoclonal antibody by their treating physician (prior therapy with ICI is allowed).
- Have an understanding of the protocol and its requirements, risks, and discomforts.
- Are willing to undergo peripheral blood collection at the time points mentioned in the protocol.
- Are able and willing to sign an informed consent.
Exclusion Criteria:
- Patients under 18 years of age.
- Inability of the patient to understand the informed consent or be compliant with the protocol.
- Patients receiving any concurrent anti-cancer therapy or investigational agents (with the exception of an anti-PD-1/anti-PD-L1 agent as mentioned above).
- Patients who are pregnant, nursing, or are of childbearing potential and are unwilling to employ adequate contraception.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Svetomir Markovic, M.D., Ph.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available