NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts

Study Overview
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Brief Summary
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This study will explore the ability of patients on first line combination immunotherapy to sample cytokines at home. The data from this study will be used to evaluate the feasibility of in-home testing and the ability to analyse patients cytokine profiles retrospectively to help feed the development of further studies.

Detailed Description
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Patients will be informed of the study and given a minimum of 24 hours to consider. Once consented patients will enter the study where they will take cytokine samples at home over a 12 week period.

Official Title
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NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts

Conditions
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Cancer, Metastatic Melanoma, Renal Cell Carcinoma, Non-small Cell Lung Cancer

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary informed consent. Aged at least 18 years. Diagnosis of locally advanced or metastatic RCC, Melanoma or NSCLC In the opinion of the investigator deemed suitable to receive first-line combination immunotherapy (RCC and MM) or combination immunotherapy and chemotherapy (NSCLC). Willingness to comply with scheduled trial procedures. Capable of performing own dry blood sampling procedure, or a carer who is willing and able to perform them. Exclusion Criteria: Previous immunotherapy (including any CPI either as single agent on in combination, or high dose interleukin-2). Judgement by the investigator that the individual should not participate if they are unlikely to comply with study procedures and requirements. Patients receiving long term oral anticoagulation deemed by the clinician to be at risk from daily finger pricking.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|This is an observational study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient adherence to protocol defined DBS time points. | the number of DBS samples successfully collected against the number of total expected samples | 12 months | 
| Number of in-home DBS samples passing quality assurance checks in patients receiving CPI therapy by multi-cytokine ELISA. | the number of DBS samples passing quality assurance checks against the number of DBS samples successfully collected. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare cytokine concentrations by DBS sampling and intravenous blood sampling by multi-cytokine ELISA. | The changes of cytokine concentrations will be estimated by the log-ratio of cytokine concentrations measured at two time points. The trend of cytokine concentration during treatment will be estimated by fitting a linear regression model based on all cytokine concentrations collected during treatment. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunotherapy, immune related adverse event, cytokine release