Biomarkers to Predict for and Monitor Response to PD-1/PD-L1 Inhibitors

Overview

About this study

The primary objective of this collaborative study is to collect biospecimens for the evaluation of internally developed assays designed to predict for and monitor response to currently available PD-1/PD-L1 inhibitors.

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:

• 18 years of age or older

• Histologic evidence of malignancy (including melanoma, lung cancer, or other malignancies for which treatment with an anti-PD-1 or anti PD-L1 monoclonal antibody is deemed appropriate)

• Recommendation by the treating provider to initiate therapy with a commercially available, FDA approved, anti-PD-1 or anti PD-L1 monoclonal antibody

• An understanding of the protocol and its requirements, risks, and discomforts

• The ability and willingness to sign an informed consent

Exclusion criteria:

• Pregnancy or lactation (for females)

• Inability on the part of the patient to understand the informed consent or be compliant with the protocol

• Any condition, which in the opinion of the patient’s treating oncologist, or the provider performing the biopsy procedure, would make participation in this protocol unreasonably hazardous for the patient (including a history of a serious or life-threatening allergic reaction to such local anesthetics as lidocaine or xylocaine)

Provisions for the inclusion of minorities: All eligible patients will be encouraged to enroll regardless of ethnicity, gender, or race.

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

Jacksonville, Fla.

Mayo Clinic principal investigator

Richard Joseph, M.D.

Closed for enrollment

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Alan Bryce, M.D.

Closed for enrollment

Contact information:

Alan Bryce M.D.

(480) 301-4800

Bryce.Alan@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Closed for enrollment

Contact information:

Minetta Liu M.D.

(507) 293-0526

Liu.Minetta@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20492001

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