Spatial and Molecular Architecture of Tumor Environments Responsive to IO (immuno-oncology) Therapy
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: 17-004117
Sponsor Protocol Number: 17-004117
About this study
The purpose of this study is to gain stepwise understanding of the fundamental biology governing human antitumor immunity, by systematic study of the tumor-immune interface at the level of the TME, taking advantage of the heterogeneity of different interacting tumor and immune cell subsets.
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 orolder
- Histologic proof of malignancy, including metastatic melanoma and metastatic non-smallcell lungcancer
- CT or PET/CT evidence of measurable lymph node involvement, 2-4cm in size in the longest diameter
- Recommendation by the treating provider to initiate therapy with a commercially available, FDA approved, anti-PD-1-based therapy or anti-PD-L1therapy
- The ability and willingness to sign an informed consent
Exclusion Criteria:
- Pregnancy or lactation (forfemales); pregnancy test will have been completed as per standard of care prior to treatment and does not need to be repeated for this study
- Inability on the part of the patient to understand the informed consent or be compliant withthe protocol
- Previous adjuvant immunotherapy with immune checkpointinhibitor(s)
- Previous systemic immune checkpoint inhibitor(s)therapy
- Other active malignancies within 3years
- Any conditions, 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 bleeding disorder and a serious or life- threatening allergic reaction to such local anesthetics as lidocaine orxylocaine)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available