Recruiting

Anti-PD-1 Therapy

Sponsor:

Mayo Clinic

Code:

NCT06075524

Conditions

Clinical Stage III Cutaneous Melanoma AJCC v8

Clinical Stage IV Cutaneous Melanoma AJCC v8

Locally Advanced Lung Carcinoma

Locally Advanced Malignant Solid Neoplasm

Locally Advanced Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Electronic Health Record Review

Study Details

Brief summary:

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.

Conditions

Clinical Stage III Cutaneous Melanoma AJCC v8

Clinical Stage IV Cutaneous Melanoma AJCC v8

Locally Advanced Lung Carcinoma

Locally Advanced Malignant Solid Neoplasm

Locally Advanced Melanoma

Study ID

NCT06075524

Start date

Jun 15, 2015

Status verified date

Jun, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 immune checkpoint inhibitor (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:

  • Inability on the part 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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (Blood and stool sample collection)

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.

Interventions

Biospecimen Collection

Undergo blood and optional stool/tissue sample collection

Electronic Health Record Review

Medical records are reviewed

Primary outcome measure

  • Role of Bim for monitoring disease status during anti-PD-1 therapy [ Time Frame: Up to 10 samples: at baseline; 6 weeks after initiation of therapy; subsequently at each radiographic tumor assessment (starting at approx. 9-12 weeks) including at confirmed disease progression. ]
  • Mechanisms of resistance to anti-PD-1 blockade [ Time Frame: Up to 10 samples: at baseline; 6 weeks after initiation of therapy; subsequently at each radiographic tumor assessment (starting at approx. 9-12 weeks) including at confirmed disease progression. ]
  • Quantify and modulate levels of NKG7 mRNA in CD8+ T cells [ Time Frame: Up to 10 samples: at baseline; 6 weeks after initiation of therapy; subsequently at each radiographic tumor assessment (starting at approx. 9-12 weeks) including at confirmed disease progression. ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Svetomir N. Markovic, MD, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-18.