Clinical trial · Observational
Evaluation of Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types
Maximizing Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clinical Stage III Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IV Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Locally Advanced Lung Carcinoma | Lung Carcinoma | CURATED_BROADER | 0.78 |
| Locally Advanced Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
| Locally Advanced Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Metastatic Lung Carcinoma | Lung Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Stage III Lung Cancer AJCC v8 | Malignant Lung Neoplasm |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (Blood and stool sample collection)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Electronic Health Record Review
Primary outcomes (3)
- measure
- Role of Bim for monitoring disease status during anti-PD-1 therapy
- timeFrame
- 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.
- description
- Will be assessed by serial measurements of Bim levels in tumor-reactive CD8+ T cells from the peripheral blood of patients with advanced cancer undergoing therapy with an anti-PD-1 monoclonal antibody and correlate them with clinical outcome.
- measure
- Mechanisms of resistance to anti-PD-1 blockade
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available